Child neurologist, Dr. Fred Baughman says ADHD and other psychiatric diagnoses are fraudulent and over-diagnosed. Other experts counter that ADHD is a legitimate diagnosis.

Fred Baughman, MD

You take the position that ADHD and many of these other psychiatric diagnoses are fraudulent. Why?

An active opponent of the ADHD diagnosis, Baughman has been a child neurologist, in private practice, for 35 years. He is also a medical expert for the Citizens Commission on Human Rights (CCHR), an advocacy group founded by the Church of Scientology in 1969.

The American Psychiatric Association's diagnostic manual, the DSM, lists 18 behaviors, from which a teacher can check off behaviors she observes in the potential patient or student. Likewise, the parent or caregiver does the same thing. In the current DSM, if one checks six or more of the nine, the individual is deemed to have ADHD.

Let there be no mistake about it. Present-day psychiatry, led by the National Institute of Mental Health in league with the American Psychiatric Association and the American Academy of Child Adolescent Psychiatry, represents ADHD . . . to be a biologic abnormality of the brain, a so-called neurobiologic disorder. Their representation to the entire public and to all the teachers and all mental health professionals is that, having ticked off six or more of these nine behaviors, one has diagnosed an organic or a physical abnormality of the brain.

Their neurobiologic propaganda has been so intense for so many years, that the country believes in this. ... We've got probably, conservatively . . . six million [children in the United States] on medications for ADHD and a total of nine million with neurobiologic psychiatric diagnoses of one sort or another, on one or more psychotropic drugs. Here we're talking about as many kids as you've got people in New York City, and to me, this is a catastrophe. These are all normal children. Psychiatry has never validated ADHD as a biologic entity, so their fraud and their misrepresentation is in saying to the parents of the patients in the office, saying to the public of the United States, that this and every other psychiatric diagnosis is, in fact, a brain disease.

Establishing whether it's actually a biological brain disease seems to be a less important issue. The question is whether there aren't certain conditions with symptoms that can't be aided and addressed with psychotropic medications. What's wrong with that?

Well, what they've done essentially is to propose that there are children who, up to the time they walk down the schoolhouse path, seem to everyone to be entirely normal. But what they have proposed is that there are children who are misbehaving at school and at home who are inherently unable to achieve self-control because they've got something wrong in their brain. This ignores whether or not their parenting is optimal, and whether or not their de facto parenting in school or disciplining at school in the hands of a teacher is optimal or not. ...

But in the real world, parenting will never be optimal. Schooling is rarely optimal. But we've got a class of people telling us, psychiatrists and family physicians, that there is a drug that can help children that have a certain set of symptoms. What's wrong with that?

I think that the deficiency is, in fact, in the adults . . . It's a terrible misstep not to require any correction of the adults who are responsible for the development of the child. . . . By denying that there is any problem at all in the adults, and just accepting that it's a chemical imbalance and you're going to take a pill for it, I think you're going to leave unaddressed and undone . . . things that must be done, and should be done, and are being done in proper homes, and are being done in parochial and private schools throughout the country. . . .

Peter Breggin

Psychiatrist and author of Talking Back to Ritalin: What Doctors Aren't Telling You About Stimulants and ADHD, Breggin founded the nonprofit Center for the Study of Psychiatry and Psychology. He has been a vocal opponent of the ADHD diagnosis and he strongly opposes prescribing psychiatric medications to children.

How do you respond to the parents who give glowing testimonies about how that drug has helped their child?

In America today, it's easy to go out and get glowing testimony from parents about how wonderfully their children have been doing on Ritalin. There was a caged animal, a polar bear, in the zoo in Toronto, who was pacing up and down and looking uncomfortable, and looking like he'd really like to go back to the Arctic or the Antarctic. And they put him on Prozac, and he stopped pacing. His name was Snowball. He sat quietly and looked happy. And animal rights people gathered to the zoo and protested the drugging of a polar bear to make him into a good caged animal, and he was taken off the drug.

We have lost track of what childhood is about, of what parenthood and teaching is about. We now think it's about having good quiet children who make it easy for us to go to work. It's about having submissive children who will sit in a boring classroom of 30, often with teachers who don't know how to use visual aids and all the other exciting technologies that kids are used to. Or there are teachers who are forced to pressure their children to get grades on standardized tests, and don't have the time to pay individual attention to them. We're in a situation in America in which the personal growth and development and happiness of our children is not the priority; it's rather the smooth functioning of overstressed families and schools. . . .

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There are no miracle drugs. Speed--these drugs are forms of speed--don't improve human life. They reduce human life. And if you want less of a child, these drugs are very effective. These parents have also been lied to: flat-out lied to. They've been told that children have a neurobiological disorder. They've been told their children have biochemical imbalances and genetic defects. On what basis? That they fit into a checklist of attention deficit disorder, which is just a list of behaviors that teachers would like to see stopped in a classroom? That's all it is. . . .

One of the really obscene things that has happened is that psychiatry has sold the idea that if you criticize drugs, you're making parents feel guilty. What an obscenity that is. We are supposed to be responsible for our children. . . . If we're not responsible for raising our children, what are we responsible for? If children aren't entrusted to us for the specific purpose of our turning ourselves inside-out to be good parents, what is life about? It is a disgrace that my profession has pandered to the guilt of parents by saying, "We'll relieve you of guilt. We'll tell you your child has a brain disease, and that the problem can be treated by a drug."

That's pandering to the worst desires that we have as parents--all of us--which is to say, "I'm not guilty of this problem." . . . I'd rather be guilty as a parent, and say, "I did wrong," than say, "Son, you have a brain disease." Sure, we're all tempted. We're all tempted, when we're in conflict with our children, to hold them responsible. And how much easier it is if we don't even have to hold them responsible. . . .

Let's talk about the lawsuits that have been filed against the Novartis, the manufacturer of Ritalin.

On Tuesday, May 2, a class action suit was brought against the manufacturers of Ritalin and Novartis, against [CHADD], a parents' group that has been heavily funded by the drug companies, and the American Psychiatric Association--for the fraudulent overemphasis on the ADHD diagnosis and treatment with Ritalin. The American Psychiatric Association, CHADD, and the drug manufacturer are accused of conspiracy. The case has been brought in Texas by the law firm of Waters & Krause, and is now actually in the courts. . . . Probably there's going to be a series of related cases, or at least a number of attorneys coming together, around this issue of fraud and conspiracy in the promotion of the diagnosis and the promotion of the drug.

So that will hinge on showing what? Damage to the children?

No damage is required to be shown to the children in this case, because it's not that kind of product liability case. All that the parents have to show is that they spent money on Ritalin, when they were in fact fraudulently induced to think that it would be worth something. . . .

There's actually a great deal of evidence for a conspiratorial relationship. According to international law, you cannot directly promote a highly addictive Schedule II drug to the public. Ritalin is in Schedule II along with amphetamine, methamphetamine, cocaine and morphine. And you're not allowed to put ads in the newspaper for that. You're not allowed, according to international conventions, to directly promote to the public.

Professor of psychiatry and neurology at the University of Massachusetts Medical Center in Worcester. Author of numerous books on ADHD, including ADHD and the Nature of Self-Control and Taking Charge of ADHD: The Complete, Authoritative Guide for Parents.

There are 6,000 studies, hundreds of double-blind studies, and yet, there's still controversy. Why?

There is controversy about ADHD, I believe, partly because we are using a medication to treat the disorder, and people find that to be of concern. But there's also concern because ADHD is a disorder that appears to violate a very deeply held assumption that laypeople have about children's behavior. All of us were brought up believing, almost unconsciously, that children's misbehavior is largely due to the way they're raised by their parents and the way they're educated by their teachers. If you wind up with a child who is out of control and disruptive and not obeying, that that has to be a problem with child rearing. ... Well, along comes this disorder that produces tremendous disruption in children's behavior, but it has nothing to do with learning, and it isn't the result of bad parenting. And therefore it violates these very deeply held ideas about bad children and their misbehavior.

And as long as you have this conflict between science telling you that the disorder is largely genetic and biological, and the public believing that it arises from social causes, you're going to continue to have tremendous controversy in the mind of the public.

Now, there is no controversy among practicing scientists who have devoted their careers to this disorder. No scientific meetings mention any controversies about the disorder, about its validity as a disorder, about the usefulness of using stimulant medications like Ritalin for it. There simply is no controversy. The science speaks for itself. And the science is overwhelming that the answer to these questions is in the affirmative: it's a real disorder; it's valid; and it can be managed, in many cases, by using stimulant medication in combination with other treatments.

Many people in the public ask, "Where were these kids when I was growing up? I've never heard of this before." Well, these kids were there. They were the class clowns. They were the juvenile delinquents. They were the school dropouts. They were the kids who quit school at 14 or 15 because they weren't doing well. But they were able to go to work on their parents' farm, or they were able to go out and get in a trade or get into the military early. So they were out there.

. . . Back then, we didn't have a professional label for them. We preferred to think of them more in moral terms. They were the lazy kids, the no-good kids, the dropouts, the delinquents, the lay-about ne'er-do-wells who were doing nothing with their life. Now we know better. Now we know that it is a real disability, that it is a valid condition, and that we shouldn't be judging them so critically from a moral stance. . . .

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Skeptics say that there's no biological marker--that it is the one condition out there where there is no blood test, and that no one knows what causes it.

That's tremendously naïve, and it shows a great deal of illiteracy about science and about the mental health professions. A disorder doesn't have to have a blood test to be valid. If that were the case, all mental disorders would be invalid--schizophrenia, manic depression, Tourette's Syndrome--all of these would be thrown out. ... There is no lab test for any mental disorder right now in our science. That doesn't make them invalid.

William Dodson

A psychiatrist in Denver, Colorado, Dodson ascribes ADHD mostly to biological causes. He is paid by Shire Richwood, the makers of Adderall, to educate other physicians about the drug's efficacy.

. . . In this country, there is a tenet of faith that says that any difficulty in life can be overcome if you have a good character, if you try hard enough and long enough. And so they don't like that tenet of faith challenge, that there are some children who come from the womb genetically predisposed to being inattentive, compulsive, somewhat reckless, and perhaps aggressive, no matter how hard they try. Trying harder is ineffective.

These people confuse an explanation for misbehavior and failure with an excuse. In point of fact, when people are diagnosed with ADHD, more is expected of them, not less. Now that you've got the diagnosis, now that you're on medication, our expectations for your performance in life are going to increase. But there are a lot of people who say, "I don't want to let the person off. I don't want this to be an excuse." But it's not an excuse. It's an explanation. . . .

I would ask those people to prepare themselves for that day 15 or 20 years from now when their child comes to them and says the following, "Now, let me get this straight. You saw that I was struggling. You saw that I was failing in school. You saw that I couldn't fall asleep at night. You saw that I was having trouble with my interpersonal relationships. You knew that it was ADHD. You knew that it had a good safe treatment. And you didn't even let me try? Explain that to me."

Those folks had better start working on their answer right now, because they're going to need 15 or 20 years to come up with a compelling answer for their child who asks them that question. "You saw me struggling and you did nothing?" That's a good question. And to me, it's a far more compelling one than saying, "We don't have perfect answers, therefore, let's do nothing."

Peter Jenson

Formerly the head of child psychiatry at the National Institute of Mental Health, Jensen was the principal author of the landmark NIMH study: NIMH, the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA). He is now the director of Columbia University's Center for the Advancement of Children's Mental Health.

There doesn't seem to be a lot of consensus about ADHD, even among your own peers.

I think there's consensus among most medical professionals that ADHD is a neurobehavioral disorder, that it's severe, that it affects boys somewhat probably more than girls, and that it's treatable. Now, where consensus begins to break down is how workable the treatments are, and effective and safe over the long-term; and what the exact causes of it are. And it likely has many different causes.

There isn't good consensus about the best way to draw the boundaries between ADHD and other syndromes. But I think you will find that most experts do agree that it's a real disorder that we can characterize reliably, that it has bad outcomes if left on its own, that we can do something about it, and that there is a research agenda that does need further pressing forward and carrying out. . . .

The job of medical science is to decide when it's a real medical condition that has suffering and impairment and lowers the quality of life--and sometimes not only lowers the quality of life, but lessens productivity and even actual days of life. Depression is a good example; we know there that life is actually shortened by suicide.

But kids with ADHD are also at risk for dying somewhat earlier. They are at risk for accidents. It's true for most of the psychiatric disorders. We don't know all the reasons why that is. Sometimes it's accidents, sometimes it's something like suicide. Sometimes it's because people don't obtain adequate health care. There are a lot of mysteries here. But the diseases of the mind shouldn't be treated any differently than the diseases of the other parts of the body, and we've done that too much, I think, as a society. . . .

What about the idea that ADHD is not a disease--that it's simply behavior that's a result of ineffective parenting?

There's no question that a child's behavior affects adults, and adults' behavior affects children. We call that "the human condition." Can it be the case that some children's difficulties are because they're not being handled appropriately? Absolutely true, of course. But does that explain ADHD? Well, all of the studies suggest just the opposite, in fact. When we do these studies to teach parents the most elegant, best parenting strategies that we know how to do--including things you have to get a PhD in parenting to learn--when we give parents and teachers those skills, does it make these problems go away? No. It reduces them a little bit, but there's something different for many of these children. . . .

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There is a real need to get the message out, to help parents understand ADHD. This is not something a child chooses just to do. "Oh, I think I'm going to have real difficulties attending," or, "I don't want to attend," or "I want to look out the window and not attend to the blackboard." If you study these kids as we have, these kids feel bad about themselves. They don't want to be this way. In many ways, it's like a learning disability. Whereas you can maybe sit and listen and attend to me for hours on end, these kids' minds are off after 10 or 15 or 20 seconds. . . . Most kids can track this kind of situation, or a classroom situation, for minutes, tens of minutes, twenties of minutes, or even an hour on task, with minor deviations. . . . These kids can't. It's not that they're willfully disobedient or that we have bad teachers. . . .

Harold Koplewicz

Vice chairman of psychiatry at New York University, Koplewicz believes that ADHD is a legitimate brain disorder. He wroteIt's Nobody's Fault: New Hope and Help for Difficult Children and Their Parents. He is director for the New York University Child Study Center.

A lot of people out there say that all of this is just a fraud, that you've invented this disorder, along with hundreds of other psychiatrists and along with the pharmaceutical industry, which just wants to make more money. They say that there is no litmus test diagnosing ADHD, and this is just a whole bunch of subjective symptoms. What do you say to those people?

I think that the most important part is that when you're able to systematically study what these kids look like long-term, you start to recognize that without treatment, these children lose out on a normal life. They can't get the joy of getting decent grades. They can't get the joy of being picked to be on a team. They get very demoralized. They don't necessarily get depressed, but life becomes a very demoralizing place. If you're yelled at on a continual basis at your job, you'll quit. If you go to school on a regular basis and you're constantly missing out on whatever is being taught and you start to feel that you're foolish and stupid, you learn to quit. And that's maybe one of the reasons why you drop out. . . .

To suggest that this is a fraud, that somehow children are being abused by these treatments, is really an outrage, because for these kids, to not get treated is really the greatest abuse and neglect.

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next: Controversies in the Diagnosis and Treatment of ADHD: One Doctor's Perspective
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ADHD expert, Dr. Lawrence Diller, criticizes the role insurance and pharmaceutical companies play in over-diagnosis of ADHD.

Lawrence Diller, M.D.

Author of Running on Ritalin, Diller received his medical degree from Columbia University's College of Physicians and Surgeons. While he has diagnosed some children in his private practice with ADHD, Diller has criticized the proliferation of the ADHD diagnosis and the rise of "cosmetic psychopharmacology."

What role do the insurance companies and pharmaceutical companies play in the world of ADHD?

. . . There's a suit going on right now in three states. It alleges that the major pharmaceutical company that makes Ritalin, the Novartis Company, along with the American Psychiatric Association, the main representatives of organized medicine in the ADHD movement, and the self-help group CHADD have conspired to dupe the American public into believing that there's such a thing as ADHD, and then thrust upon innocent children a potentially dangerous drug.

The suit alleges that there's a conspiracy. Now, there may be some legal definition that meets the conspiracy angle. But I don't believe that there's any conspiracy at all. We have what I call the "invisible hand" of Adam Smith at work. Adam Smith, as you know, wrote the fundamental textbook on capitalism. And we have market forces at major play here, getting people to think a certain way about medications, and then operating on the doctors and the patients to get them to take them first--often at the expense of other interventions that work.

As a doctor, how do you experience those forces?

. . . I experience them, first of all, by this unbelievable advertising barrage that has hit me first, and now is hitting the consumer directly. . . . I think Novartis has acted quite responsibly, relatively speaking, because I think Ritalin represents a drop in the bucket to them in terms of the kind of money they make. They're much more worried about their bio-engineered foods these days than they are about Ritalin.

On the other hand, the makers of Adderall have presented what I consider to be . . . the most disingenuous, elaborate campaign I've ever experienced. . . . Adderall has passed Ritalin in terms of trade medication written for ADHD. I've been offered $100 if I will sit and listen to someone talk about ADHD, funded by Adderall, for 15 minutes on the telephone, and then fill out a five-minute questionnaire. . . .

And now, with the loosening of controls on the pharmaceutical industry by the FDA, there is this direct marketing to families. You see this picture. . . . Well, it doesn't say that it's for Concerta. It says, "Learn more about ADHD." And it's this picture of this smiling boy who has a pencil in his hand, and on either side of him, his parents are beaming. . . . And underneath, it says something like, "They're happy, because now they know his ADHD is being treated." What's the problem with that? The problem is it pushes people to only one way of thinking about the problem--that this is a biological problem, and that it needs a drug. . . .

Is there an imbalance in how much money goes to studying the efficacy of drugs versus the efficacy of other things?

Yes. That's the other way that the market forces are operating here, in that virtually every ADHD researcher, now, because of previous cutbacks and because there is money out there, takes money from the pharmaceutical industry to do their research. And whether or not you're a doctor in the local hospital . . . or you are one of the editors of the New England Journal of Medicine, we all know that research gets influenced by the funding source.

And this is not impugning these men. It's just how it works. They don't publish negative findings. The studies are tilted more toward counting symptoms and pills, rather than looking at the bigger picture. And if you look at a very narrow picture, if you just ask very narrow questions, you will get answers that miss the big picture.

Dr. Peter Jensen, a respected authority in this field, says that, in the case of children's psychiatric medications, that it's not true; that the research money comes from the government, because the pharmaceutical companies are afraid of litigation, and they don't want to go there.

That was the case. It was difficult to fund pharmaceutical research in children, particularly psychiatric pharmaceutical research in children, because there was seen to be no market until the 1990s. The government added this rider, where the pharmaceutical company will get an extra six months of patent protection if they study the drug in children. So what we're going to get, and what we're getting, is a flood of pharmaceutical research money directed toward children. And one could be very glad for that in some ways. But again, if we only ask questions about how many symptoms does the kid have, and how many pills should he take, we are going to get a very, very narrow group of answers of what ails the kid, and what should be done about it.

So we are entrusting the research on our children's mental health and the solutions for their problems to pharmaceutical companies with vested interests?

You got it. It's clear to all of us, even those of us who do receive medication pharmaceutical money, which I don't. And I would like to, because I have to pay for my own trips. But the moment I do, I'm potentially influenced by that money.

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William Dodson

A psychiatrist in Denver, Colorado, Dodson ascribes ADHD mostly to biological causes. He is paid by Shire Richwood, the makers of Adderall, to educate other physicians about the drug's efficacy.

. . . Over the last ten years, there has been extraordinary pressure within the medical field to deliver all medical care much more quickly and, therefore, much more cheaply, than it ever has been delivered before. And so there is a lot of economic pressure to diagnose and treat all disorders, medical or psychiatric, more cheaply and more quickly. So surely, yes, that's going to trickle down to the diagnosis of ADHD.

Can ADHD be diagnosed in a 15-minute well-baby check-up at the pediatrician? No way. In order to do a good, adequate evaluation, you need several hours: to do the evaluation: to rule out all the things that might mimic ADHD; to thoroughly evaluate all the things that can co-exist within ADHD; to educate the parents about the use of medication, and about the ancillary treatments that are going to be necessary; to do a quick screening for learning disabilities. A good, thorough evaluation takes time.

But we're not set up to do that?

We're set up to do it. It's that ADHD and managed care just don't go together. Managed care wants it done quickly and cheaply, and ADHD can't be done quickly and cheaply.

Another controversy is the role of the pharmaceutical companies in marketing these drugs. . . . The pharmaceutical companies make profits off of the sale of Ritalin or Adderall or Concerta. They're companies. They can strategize and put out a marketing message. The alternative therapies--such as behavioral therapy or psychotherapy--don't have that kind of lobbying muscle or marketing muscle. Therefore, it tilts the balance in favor of medication over other therapies. ... Do we have a structural bias in favor of medication?

... Everything in the United States is driven by the profit motive. We get better cars because we have a private enterprise of car manufacturers, who continue to improve their product in hopes of making more sales and making more money for their investors. That's the set-up we have in the United States. If people could demonstrate clear effectiveness from the treatments that didn't involve medication, I think that there would be a lot of people beating a path to their door. The fact is that they haven't been able to demonstrate that. . . .

Peter Jensen

Formerly the head of child psychiatry at the National Institute of Mental Health, Jensen was the principal author of the landmark NIMH study: NIMH, the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA). He is now the director of Columbia University's Center for the Advancement of Children's Mental Health.

Perhaps part of the problem is that most of the studies just study the medications, so the data is there for the medication. Perhaps there isn't that much other data because there's not a lot of money out there to study the impact of behavioral therapies?

In actual fact, the money to study the medications has not been any more plentiful than the money to study the behavior therapies. The drug companies have not wanted to study kids and medicines. They're scared of them, because they've been afraid of lawsuits. . . . So 80 percent to 90 percent of the research has all been supported by the federal government. And what the federal government would do is not say, "Oh, we want medication studies." No, they'd say, "We want studies." . . . Two or three years ago, we've gone through and we counted all of the studies in the ADHD area that met certain criteria.

Well, we had about 600 studies--good clinical trials of one form of meds or another. But there were another 1,500 studies of non-meds. The med studies are easy to describe, and they're easy to kind of get the word out on. But in actual fact, most studies are not medication studies. . . . We hear about medications in the news, because it's a bit of a tempest in a teapot. But we have a lot of studies of the other treatments. ...

The pharmaceutical industry spends a lot of money in an attempt to convince you that that little pill is the next little miracle. How do you feel about that?

The FDA regulates what the drug companies--or anyone, for that matter--can do and what they can advertise if it's a pharmaceutical. ... What the drug companies are doing is guided by science. It's not the only science, but it's guided by science, and it's regulated by the federal government. ... So do I think it's a good thing that industry is trying to teach doctors about what their science has shown? . . . Absolutely. I'm all for it. We need more of it for science. . . . We need more of it for the behavior therapies. . . .

Fred Baughman

An active opponent of the ADHD diagnosis, Baughman has been a child neurologist, in private practice, for 35 years. He is also a medical expert for the Citizens Commission on Human Rights (CCHR), an advocacy group founded by the Church of Scientology in 1969.

Psychiatry and the pharmaceutical industry have become financial economic partners. And frankly, part of their economic compensation has been to develop a strategy whereby they claimed, without science, that all mental illnesses, all things behavioral and emotional, are physical brain dysfunctions or abnormalities.

Representing such things as depression, anxiety, conduct disorder, ADHD, oppositional defiant disorder, and learning disabilities as diseases, absent any scientific proof, is to deceive the public. It preempts the public's right to informed consent in every single case.

. . . [As Running on Ritalin author Lawrence Diller] pointed out, they've led the public to believe that these are brain diseases, chemical imbalances--making it logical for the public to think that a pill is going to be the solution. . . .

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But the charge that the psychiatrists and the pharmaceuticals have joined together in a joint common mercenary interest is quite a charge. How can you say that?

I'm not the only one saying this. In the October, 1995, in the DEA background paper on methylphenidate, which is Ritalin, the DEA says that they have been contacted by the United Nations International Narcotics Control Board (INCB), that had expressed concern about the financial ties of Ciba-Geigy, then the manufacturer of Ritalin, to CHADD. They noted that CHADD had received over $775,000 from Ciba-Geigy, I think up through 1994, and eventually the figure went over $1 million. The INCB charged CHADD with being a vehicle for marketing a controlled substance directly to the public in violation of the Controlled Substances Act of 1971, and international statute by which all countries, all signatories, agreed.

Ciba-Geigy confessed at that point that CHADD was their conduit to the public. CHADD personnel and NIMH personnel were regularly in-house at the Department of Education office of Special Education authoring ADHD materials. I think CHADD made a grant, I believe, of $700,000-some to the Office of Special Education to make a video about ADHD. Then when John Merrow, in his video production in about 1995 . . . pointed out the financial ties between the Ritalin manufacturer, Ciba-Geigy and CHADD, I think that money was then given back by the Department of Education, back to CHADD.

Peter Breggin

Psychiatrist and author of Talking Back to Ritalin: What Doctors Aren't Telling You About Stimulants and ADHD, Breggin founded the nonprofit Center for the Study of Psychiatry and Psychology. He has been a vocal opponent of the ADHD diagnosis and he strongly opposes prescribing psychiatric medications to children.

There are many, many reasons why we're giving more and more psychiatric drugs to children. Probably the most important reason is simple marketing. The drug companies, like the tobacco industry, like the alcohol industry, are highly competitive, and are always searching out new markets. The adult market has been saturated for anti-depressant drugs. How many millions and millions of people can take Prozac and and all the other drugs? We have more adults taking anti-depressants than the National Institute of Mental Health estimates there are depressed people in the United States. The market is saturated, so the pressures move automatically to other markets. And the biggest next market is children. So you have drug company representatives, you have drug company-sponsored conferences examining this issue, or encouraging this issue of marketing to children. ...

What Ciba-Geigy, now a division of Novartis, has done is to fund a parents' group, CHADD, and the group has then gone and promoted Ritalin to the public. So that's one potential aspect to the situation.

How is it different than another pharmaceutical company supporting the American Diabetes Foundation or the American Cancer Society with funding? How is it different that Ciba-Geigy is providing some funding to CHADD?

One of the big differences in what Ciba-Geigy is doing, say, compared to a drug company who might give money for a diabetes drug to the AMA, is that Ritalin is a Schedule II--a highly addictive drug. And there are special controls put upon it by the US government. CHADD, in fact, has lobbied the US government to try to get Ritalin taken out of Schedule II. They couldn't do anything more valuable for the drug company, and more dangerous to the public, than that. Fortunately, they failed, and they failed in part because of our disclosures . . . about CHADD having so much money from the drug companies. . . .

What role did the pharmaceutical industry play in promoting Ritalin and Prozac to the country?

Even before Prozac was approved by the FDA, the drug company was sponsoring seminars for doctors throughout the country on the biochemical basis of depression, mentioning over and over again serotonin, which is the neurotransmitter that's affected by Prozac. They didn't happen to mention that there may be 200 neurotransmitters in the brain, and that connecting any one to depression is absolutely foolish speculation. The brain is an integrated organ, with probably thousands of substances participating in its function.

To label one, serotonin--which is, in fact, a widespread neurotransmitter that goes to every single lobe of the brain and affects everything from memory to coordination to cardiovascular function--imagine that that one happens to be the one that's out of balance, because Eli Lilly is selling Prozac.

But people are so eager nowadays for biological explanations. So physicians and the public grabbed on to what is essentially a PR campaign--perhaps the most successful one in the last 30 years in the Western industrialized nations--that if you have a mental disturbance, it's biochemical.

Harold Koplewicz

Vice chairman of psychiatry at New York University, Koplewicz believes that ADHD is a legitimate brain disorder. He wrote It's Nobody's Fault: New Hope and Help for Difficult Children and Their Parents. He is director for the New York University Child Study Center.

I think that we should look very carefully at who's funding science. I think you'll find that, overwhelmingly, the studies looking at treatment have been funded by the federal government. The National Institute of Mental Health has spent millions and millions of dollars looking at treatments. . . . When you looked at the medicines--all different kinds of medicines that basically have the same mechanism of action--they did work, and they were effective. And when you looked at behavioral therapy, you found that behavioral therapy wasn't effective unless they were taking medications. The federal government doesn't have a bias. They're not looking to support one treatment versus another. . . .

But yet there are pharmaceutical companies that do lobby politicians, and are out there and are pushing certain things and trying to get more funding for certain other things. And sales reps come around doctors' offices and invite doctors on cruises.

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I don't think the pharmaceutical companies are affecting what the National Institute of Health is funding. I think that the reason why that's considered the gold standard is, to get funding from the National Institute of Health, you have to have a scientific research project that is peer-reviewed. Your peers review it and decide whether or not they think it's scientifically sound to use federal funds to study it.

The other question, though, about sales reps, is worthwhile. I think that doctors who are in private practice are overwhelmed with new challenges, and they are working harder than ever. Managed care has turned out not to be managed care, but managed money. We are just trying to keep the costs down of the healthcare system. So you find that doctors are seeing more patients that they ever saw before, especially if you're a primary care physician. . . .

Quite clearly, if a rep comes to your office and quickly tells you about a medication that's effective and easy and safe, that may influence your prescription practice more than reading a peer-reviewed journal. . . . And I think that that's a real problem when you have doctors who don't have enough time to keep up to date.

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What a psychiatric evaluation of a child entails.

Evaluation by a child and adolescent psychiatrist is appropriate for any child or adolescent with emotional and/or behavioral problems. Most children and adolescents with serious emotional and behavioral problems need a comprehensive psychiatric evaluation.

Comprehensive psychiatric evaluations usually require several hours over one or more office visits for the child and parents. With the parents' permission, other significant people (such as the family physician, school personnel or other relatives) may be contacted for additional information. The comprehensive evaluation frequently includes the following:

• Description of present problems and symptoms
• Information about health, illness and treatment (both physical and
• psychiatric), including current medications
• Parent and family health and psychiatric histories
• Information about the child's development
• Information about school and friends
• Information about family relationships
• Psychiatric interview of the child or adolescent
• If needed, laboratory studies such as blood tests, x-rays, or special assessments (for example, psychological, educational, speech and language evaluation)

The child and adolescent psychiatrist then develops a formulation. The formulation describes the child's problems and explains them in terms that the parents and child can understand. Biological, psychological and social parts of the problem are combined in the formulation with the developmental needs, history and strengths of the child or adolescent.

Time is made available to answer the parents' and child's questions. Parents often come to such evaluations with many concerns, including:

• Is my child normal? Am I normal? Am I to blame?
• Am I silly to worry?
• Can you help us? Can you help my child?
• What is wrong? What is the diagnosis?
• Does my child need additional assessment and/or testing (medical, psychological etc.)?
• What are your recommendations? How can the family help?
• Does my child need treatment? Do I need treatment?
• What will treatment cost, and how long will it take?

Parents are often worried about how they will be viewed during the evaluation. Child and adolescent psychiatrists are there to support families and to be a partner, not to judge or blame. They listen to concerns, and help the child or adolescent and his/her family define the goals of the evaluation. Parents should always ask for explanations of words or terms they do not understand.

When a treatable problem is identified, recommendations are provided and a specific treatment plan is developed. Child and adolescent psychiatrists are specifically trained and skilled in conducting comprehensive psychiatric evaluations with children, adolescents and families.

Source: American Academy of Child and Adolescent Psychiatry, April 2001

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Tuesday, March 20, 2001
by Leye Jeannette Chrzanowski
Copyright © The Disability News Service, Inc.

Is Electroconvulsive therapy (ECT) now safe and effective as indicated in a March 14, 2001, editorial published in the Journal of the American Medical Association (JAMA)? The author, JAMA's Deputy Editor Richard Glass, MD, asserts ECT is effective, safe, and no longer abused, and thus time to bring ECT out of the shadows. Glass fails to sway ECT critics. They are incensed that JAMA would publish such a questionable report, and remain unconvinced ECT is the harmless panacea he describes. Critics assert Glass's editorial makes erroneous assumptions, excludes important information, and ignores people who have experienced adverse effects after receiving ECT. They conclude ECT remains ineffective, abused and unsafe.

What is ECT?

According to the National Institutes of Mental Health (NIMH), ECT, sometimes more commonly referred to as shock treatment, involves producing a seizure in the brain of a patient under general anesthesia by applying electrical stimulation to the brain through electrodes placed on the scalp. According to NIMH, "Repeated treatments are necessary to achieve the most complete antidepressant response." People of all ages receive ECT -- even young children.

The Effects

ECT has been known to cause epilepsy, brain damage, memory loss, stroke, heart attacks and even death.

Glass asserts ECT earned a bad reputation in the mid-20th Century, when shock treatments were abused and overused. He also blames the movie One Flew Over the Cuckoo's Nest for contributing to an "erroneous view of ECT as a punitive, painful, and assaultive procedure used by authorities to control inconvenient creativity."

"That reputation was enhanced by the immediate adverse effects of bitten tongues and even fractured bones and teeth caused by the induction of generalized seizures, and the painful effects of electroshocks administered without anesthesia when they did not successfully induce a seizure with loss of consciousness," he writes.

"Richard Glass makes some very erroneous assumptions in this editorial, and it leaves me wondering if he really knows ECT research at all," says freelance journalist Juli Lawrence, MA, BS, BA, who received ECT in July 1994 for severe depression. Lawrence also operates an Internet Web site http://www.ect.org , which contains a vast amount of ECT information. She accumulated the articles and journal entries -- both pro and con -- after spending years researching ECT.

"He lists a few reasons that ECT is controversial, but ignores what every ECT researcher tends to ignore -- patient feedback. That has been the modus operandi of the entire ECT industry from the beginning, although it seems to be currently in vogue to say, `Well, yes, we admit ECT was misused in the past, but it's fixed today,'" adds Lawrence.

"It is disturbing that such a respected source as the Journal of the American Medical Association sees fit to describe ECT as `an effective and safe treatment,' given the fact that a significant number of people have been permanently disabled by it," says Joseph A. Rogers, executive director of the National Mental Health Consumers' Self-Help Clearinghouse in Philadelphia.

To bolster his opinion, Glass relies on the most recent task force report by the American Psychiatric Association (APA) committee on electroconvulsive therapy. First published in 1990, the 2001 edition of The Practice of ECT: Recommendations for Treatment, Training, and Privileging concludes ECT is a safe and effective treatment for severe major depression. Glass writes the committee noted that after receiving ECT, people may experience "a variable but usually brief period of disorientation," or some retrograde amnesia immediately after the ECT seizure is induced, which usually decreases with time. Glass adds that some people may experience a persistent loss of memory of events that happened directly before and after they received the ECT. Anterograde amnesia, forgetting learned information, may also occur during and following ECT, but is resolved in a few weeks, according to Glass.

"Importantly, there is no objective evidence that ECT has any long-term effect on the capacity to learn and retain new information," writes Glass.

"The APA fact sheet claims that ECT is `no more dangerous than minor surgery under general anesthesia, and may at times be less dangerous than treatment with antidepressant medications,'" adds Rogers. He asserts APA wrongly refers to ECT as "a safe, practically painless procedure" and brain damage a "myth." Rogers says APA minimizes memory problems. "Research to the contrary is ignored," he asserts.

If APA considers brain damage a myth, then it ignores the results of its own task force survey. Some 41 percent of psychiatrist responded, "Yes", and only 26 percent said, "No," when asked, "Is it likely that ECT produces slight or subtle brain damage?"

"As a neurologist and electroencephalographer, I have seen many patients after ECT, and I have no doubt that ECT produces effects identical to those of a head injury," wrote Sydney Samant, MD, in Clinical Psychiatry News, March 1983. Samant concluded that ECT "in effect may be defined as a controlled type of brain damage produced by electrical means."

In the American Journal of Psychiatry, September 1977, John M. Friedberg, MD, writes, "The potency of ECT as an amnestic exceeds that of severe closed head injury with coma. His report, "Shock Treatment, Brain Damage, and Memory Loss: A Neurological Perspective," concluded, "It is surpassed only by prolonged deficiency of thiamine pyrophosphate, bilateral temporal lobectomy, and the accelerated dementias, such as Alzheimer's."

"One reason psychiatrists are unaware that ECT is causing memory loss is that they do not test for it," wrote Peter Sterling, MD, in a January 2000 letter to the editor of Nature. Sterling who works in the department of neuroscience, at University of Pennsylvania, wrote, "Memory loss could be monitored by questioning patients before ECT about early events in their lives and then re-questioning them following each series of ECT. When this was done 50 years ago, memory losses were marked and prolonged. However, no effort has been made since to routinely perform this simple test."

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The late Marilyn Rice, founder of the Committee for Truth in Psychiatry, an organization of approximately 500 former ECT recipients was forced to give up her career as a government economist after ECT wiped out her knowledge of economics.

Lawrence says that ECT wiped out a year and a half of memories before she received ECT, and eight months of memories after her shock treatment. She believes it's important to look at ECT from every angle, and offers both perspectives on her Web site. Still, she is not convinced ECT is an effective treatment for depression, but only offers a brief respite.

Glass' editorial does not warn that ECT may cause heart damage or even death.

Last year's controversial U.S. Surgeon General's Mental Health: A Report of the Surgeon General, endorsed the use of ECT, but warned, "However, a recent history of myocardial infarct, irregular cardiac rhythm, or other heart conditions suggests the need for caution due to the risks of general anesthesia and the brief rise in heart rate, blood pressure, and the load on the heart that accompany ECT administration."

"In a large retrospective study of 3,288 patients getting ECT in Monroe County, New York, ECT recipients were found to have an increased death rate from all causes," reports Moira Dolan, MD, in The Effects of Electroconvulsive Therapy, a review of scientific literature on the subject.

She also reports, "The first three years of mandated recording of death within 14 days of ECT in the state of Texas yielded reports of 21 deaths," according to a 1996 report filed by Don Gilbert, Commissioner, Texas Department of Mental Health and Mental Retardation. "Eleven of these were cardiovascular, including massive heart attacks and strokes, three were respiratory, and six were suicides..."

"In this issue of The Journal, Sackeim et al report the results of a multicenter, randomized controlled trial that addressed the important clinical problem of preventing relapse following a course of ECT," Glass writes.

"He fails to mention that in the JAMA study, patients were given an electrical charge so high (double the maximal output) that special machines had to be manufactured, and that this kind of charge is allowed only in research, not in contemporary US practice," counters Lawrence. "Even with that doubled dose, the response rate was dismal. Out of the 290 persons who completed a full ECT series at this high electrical rate, 24 weeks later only 28 were considered to be `in remission' from depression."

Informed Consent

"In his editorial, Dr. Glass does add that some ECT recipients have reported `devastating cognitive consequences' and says that this should be `acknowledged in the informed consent process,'" adds Rogers. "Unfortunately, he does not note that the opportunity for truly informed consent rarely exists now, since many hospitals base their informed consent information on sources such as the American Psychiatric Association fact sheet, which whitewashes the risks of ECT."

In 1998, the U.S. Department of Health and Human Services released the Electroconvulsive Therapy Background Paper prepared by Research-Able, Inc., a Vienna, Virginia, contractor for the Center for Mental Health Services (CMHS). This report indicated that some 43 states regulated the administration of ECT. Nevertheless, its authors concluded that despite state laws regulating the practice of ECT, "physicians and facilities comply neither with the letter nor the spirit of the laws, nor with professional guidelines." The Wisconsin Coalition for Advocacy, for example, reviewed records and conducted in-depth interviews at a psychiatric hospital in Madison, and uncovered...

• coercion to obtain patients' consent;
• failure to honor the requests of people who refused treatment;
• failure to provide patients with sufficient information about the procedure to allow them to make an informed decision; and
• absence of consent to treat people who were mentally unable to give consent.

"The American Psychiatric Association's own consent form doesn't even mention the high relapse rate, and mentions memory loss and cognitive damage as something rare and nearly freakish," adds Lawrence.

Has the abuse and overuse of ECT has declined over the years?

"One only has to look in the courtrooms of New York and spend an hour talking with Paul Henri Thomas, a man who has received as many as 70 forced electroshocks and is fighting against 40 more," asserts Lawrence.

"Or visit the courtrooms in Michigan, where it is against state law to give involuntary ECT to a person who does not have a guardian; yet in the last year, two hospitals and two judges have ignored state law and done it anyway. And you might talk to prominent [British] psychiatrist Dr. Carl Littlejohns, who is a proponent of ECT. Last year he criticized the American practice of ECT saying it was not standardized at all, and called it `most unsettling.' Or talk to the thousands of ECT survivors who say they have devastating, permanent damage and were lied to about the longevity of ECT on depression," advises Lawrence.

The National Mental Health Consumers' Self-Help Clearinghouse's policy is that potential ECT recipients have a right to be educated about the benefits and dangers of the controversial procedure before they make up their minds about it.

The Financial Factor

Many ECT proponents including some cited by Glass do not disclose they may have a financial conflict. For example, he cites Richard D. Weiner, MD, Ph.D., who heads Duke University Medical Center's Electroconvulsive Therapy Service and the APA task force on ECT which petitioned the Food and Drug Administration to lower its classification of ECT machines in 1982.

"As a paid 'consultant' to shock machine companies, Weiner designs virtually all of the shock machines in the United States," asserted Linda Andre, head of the New York City-based Committee for Truth in Psychiatry in 1999. "He admits getting money from shock machine companies but says it's deposited in his `research' account."

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Andrew D. Krystal, MD, director of Duke's Sleep Disorder Center, an associate of Weiner's who is frequently cited in pro-ECT journals received $150,036 in funding from the NIMH in fiscal year 1998 to conduct research on improving ECT's effectiveness.

"In this issue of The Journal, Sackeim et al report the results of a multicenter, randomized controlled trial that addressed the important clinical problem of preventing relapse following a course of ECT," writes Glass.

Harold A. Sackeim, Ph.D., is chief of the department of biological psychiatry at the New York Psychiatric Institute, where he directs the ECT research program and co-directs the Late Life Depression Research Clinic. The ECT machines Sackeim used in the research Glass cites above were donated by MECTA, Corporation, one of two US companies that manufacture these devices. MECTA reputation is less than stellar. In 1989, the MECTA, Model D machine was used to give ECT to Imogene Rohovit. As a result, she sustained permanent brain damage and could no longer work. The Iowa nurse and her family successfully sued METCA for an undisclosed amount.

Electroconvulsive Therapy authored by Richard Abrams, MD, a professor of psychiatry at the Chicago Medical School, is the primary reference used by ECT practitioners. Abrams, a member of the editorial board of Convulsive Therapy, has authored numerous articles and books, and lectured extensively on the subject of ECT. Glass does not mention this highly esteemed ECT expert by name, however, APA's 1990 task force report relies heavily on Abrams' ECT expertise. Abrams also rarely mentions his interest in ECT goes beyond his practice, writings and lectures.

"Somatics, Inc. was founded in 1983 by two internationally recognized ECT experts and professors of psychiatry for the purpose of manufacturing and distributing the Thymatron? brief-pulse electroconvulsive therapy instrument," reads a statement on the company's Web site. Missing from the site are the names of the two psychiatrists -- Abrams, and Conrad Swartz, MD, Ph.D., a professor at the University of South Carolina, an ECT practitioner, who writes extensively about ECT, and also designs ECT machines and other related devices.

For years, Abrams failed to disclose his financial interest in the company. He did not disclose it in his pro-ECT article, "The Treatment That Will not Die," published in the academic journal Psychiatric Clinics. When journalist David Cauchon interviewed an editor at Oxford University Press, the publisher of his book, she claimed Abrams had never disclosed his financial interest in Somatics. Cauchon reveals this information in his article "Doctor's Financial Stake in Shock Therapy" published in USA Today, December 6, 1995. (A financial disclosure is now included.)

"Abrams says it's ridiculous to think his ownership of a shock machine company may create a conflict of interest," wrote Cauchon. In the article, Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, chides Abrams and Swartz for failing to disclose their financial interest in Somatics, when they lecture or write about ECT. Caplan told Cauchon Abrams and Swartz should "absolutely, without a doubt, disclose their ownership in all their publications," and also on informed consent forms.

Psychiatrists find insurance programs, including federal programs such as Medicare and Medicaid, are willing to pay for less costly shock treatments than for psychotherapy sessions.

"With the insurance companies there isn't a limit [for ECT] like there is for psychotherapy," Gary Litovitz told Sandra Boodman in an interview for her article, "Electric Shock...It's Back" published in The Washington Post, September 24, 1996. "That's because it's a concrete treatment they can get their hands around. We have not run into a situation where a managed care company cut us off prematurely," stated the medical director of Dominion Hospital, a private 100-bed psychiatric facility in Falls Church, Virginia.

"The number of shock treatments in Ontario's community hospitals has more than doubled in the last ten years, Ministry of Health statistics now show," writes Maria Bohuslawsky in The Ottawa Citizen, March 19, 2001. She reports that 40 percent of the 2,087 people who received shock treatment from 1996-1997, were older people -- a growing trend. Bohuslawsky writes that those on both sides of the ECT issue agree that "the trend is partly due to a push for shorter hospital stays: As a short-term treatment, electroshock works faster than antidepressant drugs."

The People Factor

"Neither congressional hearings nor other government proceedings have ever heard from shock survivors and other opponents of shock in representative numbers," states the National Council on Disability in From Privileges to Rights: People labeled With Psychiatric Disabilities Speak for Themselves, a 2000 report the federal agency prepared for the president and Congress. "More often, the proponents of shock have either authored the reports or had major involvement in writing them, often without disclosing conflicts of interest (such as financial involvement with the manufacturers of shock machines), while opponents of shock treatment have been excluded from the process."

"Dr. Glass says it's time for ECT to come out of the shadows," asserts Lawrence. "I've got news for him -- it's out, but not always in the positive light he seems to want. Every day I hear from new people who now consider themselves survivors of ECT. When these patients try and talk to their doctors about their complaints, they are simply ignored or met with scorn. That's what is in the shadows, and it's because the industry refuses to recognize their experiences."

ECT critics raise legitimate concerns which Glass omits from his editorial. The absence of such information, which practitioners and the public have a right to know, casts a dark shadow on Glass's editorial and the Journal of the American Medical Association's credibility.

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A Randomized Controlled Trial

Harold A. Sackeim, PhD; Roger F. Haskett, MD; Benoit H. Mulsant, MD; Michael E. Thase, MD; J. John Mann, MD; Helen M. Pettinati, PhD; Robert M. Greenberg, MD; Raymond R. Crowe, MD; Thomas B. Cooper, MA; Joan Prudic, MD

Context Electroconvulsive therapy (ECT) is highly effective for treatment of major depression, but naturalistic studies show a high rate of relapse after discontinuation of ECT.

Objective To determine the efficacy of continuation pharmacotherapy with nortriptyline hydrochloride or combination nortriptyline and lithium carbonate in preventing post-ECT relapse.

Design Randomized, double-blind, placebo-controlled trial conducted from 1993 to 1998, stratified by medication resistance or presence of psychotic depression in the index episode.

Setting Two university-based hospitals and 1 private psychiatric hospital.

Patients Of 290 patients with unipolar major depression recruited through clinical referral who completed an open ECT treatment phase, 159 patients met remitter criteria; 84 remitting patients were eligible and agreed to participate in the continuation study.

Interventions Patients were randomly assigned to receive continuation treatment for 24 weeks with placebo (n=29), nortriptyline (target steady-state level, 75-125 ng/mL) (n=27), or combination nortriptyline and lithium (target steady-state level, 0.5-0.9 mEq/L) (n=28).

Main Outcome Measure Relapse of major depressive episode, compared among the 3 continuation groups.

Results Nortriptyline-lithium combination therapy had a marked advantage in time to relapse, superior to both placebo and nortriptyline alone. Over the 24-week trial, the relapse rate for placebo was 84% (95% confidence interval [CI], 70%-99%); for nortriptyline, 60% (95% CI, 41%-79%); and for nortriptyline-lithium, 39% (95% CI, 19%-59%). All but 1 instance of relapse with nortriptyline-lithium occurred within 5 weeks of ECT termination, while relapse continued throughout treatment with placebo or nortriptyline alone. Medication-resistant patients, female patients, and those with more severe depressive symptoms following ECT had more rapid relapse.

Conclusions Our study indicates that without active treatment, virtually all remitted patients relapse within 6 months of stopping ECT. Monotherapy with nortriptyline has limited efficacy. The combination of nortriptyline and lithium is more effective, but the relapse rate is still high, particularly during the first month of continuation therapy.

JAMA. 2001;285:1299-1307

Electroconvulsive therapy (ECT) is usually administered to patients with severe and medication-resistant major depression.¹ The number of ECT procedures performed in the United States exceeds coronary bypass, appendectomy, or hernia repair.² While the response rate to ECT in major depression is high, ^{1, 3} relapse is a key problem.4 Naturalistic studies show that the relapse rate during the 6 to 12 months following ECT exceeds 50%.^5-15

Electroconvulsive therapy is the only somatic treatment in psychiatry that is typically discontinued following response, yet patients untreated following ECT response have high rates of relapse.^16-1916-18 Post-ECT monotherapy with antidepressant medication is now standard.^{9, 20-23} However, the evidence supporting this practice is flawed, and the recent naturalistic studies document high relapse rates. Studies in the 1960s suggested that continuation therapy with a tricyclic antidepressant (TCA) or monoamine oxidase inhibitor markedly reduced the 6-month post-ECT relapse rate.

Post-ECT continuation pharmacotherapy has been based on 3 studies conducted in the 1960s.^16-184, ²⁴ At that time, ECT was a treatment of first choice^{.25, 26} Relevance for continuation therapy in medication-resistant ECT responders is uncertain. Second, some patients likely benefited from the concurrent antidepressant during ECT, and continued to benefit from the medication as continuation therapy. Since use of ECT now centers on medication-resistant patients^{,1, 21, 27} the relevance of this early research is questionable. A primary goal of those studies was to determine whether concurrent treatment with TCAs or monoamine oxidase inhibitors reduced the number of ECT treatments needed. Following ECT, patients continued taking active medication or placebo or no subsequent treatment. Using 6-month follow-up periods, the findings were consistent. Patients who received a TCA or monoamine oxidase inhibitor during and following ECT had a relapse rate of approximately 20%, compared with 50% in the control groups. There are major concerns about this research.

We conducted a randomized, double-blind, placebo-controlled trial of continuation pharmacotherapy following ECT response. The treatments were a TCA (nortriptyline hydrochloride), combination treatment with nortriptyline and lithium carbonate, or placebo. A placebo-controlled trial following ECT had never been conducted in the United States. This trial was justified since the relapse rates in recent follow-up studies^5-15 often exceeded those seen with placebo in the controlled investigations from an earlier era.^16-18 A placebo-controlled trial was also justified by our hypothesis that TCA monotherapy, the best documented treatment in post-ECT relapse prevention,^16-18 has limited efficacy. Monotherapy with nortriptyline was tested since (1) early research suggested that TCA continuation therapy was effective in relapse prevention ^16-18; (2) concern that newer agents, such as selective serotonin reuptake inhibitors (SSRIs), may be less effective than TCAs in treatment of the severe episodes characteristic of ECT patients28-33; and (3) given the widespread use of SSRIs and other newer agents as first-line treatments, a low probability that ECT responders would have received an adequate TCA trial during the episode.34 We hypothesized, however, that the nortriptyline-lithium combination would be most efficacious, given the evidence that combined TCA-lithium treatment is particularly effective in medication-resistant major depression,35-41 and the supposition that regimens effective in the acute treatment of medication-resistant major depression exert protective effects as continuation treatment. Nortriptyline-lithium was also selected since few ECT remitters would have received this treatment during the episode.^{34, 42}

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METHODS

Study Site and Study Participation

The study was conducted at the Carrier Foundation (Belle Meade, NJ), a private psychiatric hospital, and at university-based psychiatric facilities of the University of Iowa (Iowa City) and Western Psychiatric Institute and Clinic (WPIC; Pittsburgh, Pa). The New York State Psychiatric Institute (NYSPI; New York) was the coordinating and monitoring center. Using the Schedule for Affective Disorders and Schizophrenia,⁴³ patients met the research diagnostic criteria⁴⁴ for major depressive disorder. They had a pretreatment score of 21 or higher on the Hamilton Rating Scale for Depression (HRSD; 24-item scale).⁴⁵ Patients were excluded if they had a history of bipolar disorder, schizophrenia, schizoaffective disorder, nonmood disorder psychosis, neurological illness, alcohol or drug abuse within the past year, ECT within the past 6 months, or severe medical illness that markedly increased the risks of ECT (eg, unstable or severe cardiovascular conditions, aneurysm or vascular malformation susceptible to rupture, severe chronic obstructive pulmonary disease).

Participants were recruited from those clinically referred for ECT. Over a 6-year period (1993-1998), 349 patients consented and participated in the pre-ECT screening (Figure 1). Patients who met inclusion/exclusion criteria for the open ECT phase were completers if they received at least 5 treatments or ended ECT earlier due to response and did not receive any psychotropic medication during the ECT course other than lorazepam (^≤23 mg/d). Of the 59 patients who did not contribute to ECT outcome data, 17 patients were dropped before ECT due to diagnostic exclusions; 14 patients could not be withdrawn from psychotropics before (n=7) or during (n=7) ECT; 12 patients terminated ECT against medical advice prior to the fifth treatment; 9 developed an intercurrent illness so ECT was not initiated (n=2) or was interrupted (n=7) (all before the fifth treatment); 6 patients withdrew consent before ECT; and 1 dropped below the inclusion threshold (HRSD score of 21) before starting ECT. Only 2 of 59 dropouts (prohibited medications) should have contributed to ECT efficacy analyses, but end point evaluations were not obtained.

To enter the continuation trial, patients had to achieve at least a 60% reduction in HRSD scores relative to pre-ECT baseline, with a maximum score of 10 both at an assessment within 2 days of ECT discontinuation and reassessment 4 to 8 days following ECT termination, while free of psychotropic medication. Since the extent of residual symptoms is predictive of relapse following antidepressant treatment,^{46, 47} the remitter criteria were particularly stringent. These criteria required both a substantial symptomatic reduction and a low absolute score both immediately and 4 to 8 days following ECT. Patients with medical contraindications to nortriptyline or lithium were excluded. Patients provided separate informed consent for participation in the ECT and continuation pharmacotherapy phases, and capacity to consent was assessed at each time point. The institutional review boards at each enrollment site and the NYSPI approved the study. Assuming a relapse rate of 50% with placebo, the goal was to enroll at least 25 patients in each randomized treatment condition to have at least an 80% probability of detecting a significant advantage in relapse time for an active treatment in a primary, intent-to-treat, parametric survival analysis.

Study Design

Patients were withdrawn from psychotropic medications, other than lorazepam (up to 3 mg/d) as needed, before starting ECT. Methohexital (0.75-1.0 mg/kg) and succinylcholine chloride (0.75-1.0 mg/kg) were the anesthetic medications, with preadministration of an anticholinergic agent (0.4-6 mg of atropine or 0.2-4 mg of glycopyrrolate). Based on clinical judgment, patients received either right unilateral or bilateral ECT, using the d'Elia⁴⁸ or bifrontotemporal²¹ placements, respectively. Electroconvulsive therapy was given 3 times per week with a customized MECTA SR1 device (MECTA Corp, Lake Oswego, Ore), which had double the maximal charge output of commercial devices in the United States. Seizure threshold was quantified at the first treatment using empirical titration.49 For right unilateral ECT, dosage at subsequent treatments exceeded initial threshold by at least 150%. Patients who did not show substantial improvement to right unilateral ECT within 5 to 8 treatments were switched to bilateral ECT. To be considered adequate, minimal seizure duration was 20 seconds of motor or 25 seconds of electroencephalogram manifestation.²¹ Length of the ECT course was determined on clinical grounds.

The ECT remitters were randomized to 3 continuation pharmacotherapy groups, stratified by classification of the index episode as psychotic depression; medication-resistant nonpsychotic depression; and nonpsychotic depression without medication resistance. Medication resistance was rated using the Antidepressant Treatment History Form.^{8, 34, 50} Medication-resistant nonpsychotic patients had to have received at least 1 adequate antidepressant trial prior to ECT. Patients with psychotic depression were not further stratified by resistance classification since only 4 (4.3%) of 92 such patients received an adequate combination antidepressant-antipsychotic trial during the episode.⁴²

Using a randomly permuted block procedure consisting of blocks of 6 patients (within site and the 3 strata), each treatment condition was equally represented. The study psychiatrist who completed the Antidepressant Treatment History Form communicated the patient classification to the pharmacist who assigned the next available patient number within the stratum. Only the site pharmacist, the study coordinator at NYSPI, and the NYSPI laboratory conducting plasma level assays had access to the randomization code. The randomization code was generated by the study coordinator at NYSPI based on the randomization tables provided by Fleiss.⁵¹ Treatment teams, outcome assessors, and data analysts were blind to treatment assignment.

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Medication was administered in sealed capsules containing 25 mg of nortriptyline, 300 mg of lithium, or microcrystalline cellulose (placebo). The capsules containing nortriptyline or lithium were distinct in appearance, and each was matched with placebo capsules identical in size, weight, appearance, and taste. Each patient was given 2 sets of pills. On the first study day, 50 mg of nortriptyline or its placebo and 600 mg of lithium or its placebo were administered. Blood samples were obtained 24 hours later and estimates were determined for the oral dose needed to produce steady-state levels of 100 ng/mL of nortriptyline and 0.7 mEq/L of lithium.52-54 On days 3 and 4, depending on the estimate, oral doses were adjusted and maintained until plasma levels were again taken on days 9 through 11. The goal was to maintain nortriptyline levels between 75 and 125 ng/mL and lithium levels between 0.5 and 0.9 mEq/L. During the 24-week trial, plasma levels were determined on 10 occasions. A yoked-control procedure was used, with a psychiatrist at NYSPI reporting simulated nortriptyline and lithium values for patients receiving placebo, based on matching by sex, age, and weight with patients who were receiving active medication.

Patients were evaluated at weekly intervals for the first 4 weeks, at 2-week intervals for the next 8 weeks, and at 4-week intervals for the remaining 12 weeks. They were contacted by telephone at weekly intervals between visits. Clinical ratings during the continuation phase were obtained by the same blinded evaluator (continuous rater) who evaluated patients throughout the ECT course. During the continuation trial, a blinded study psychiatrist assessed adverse effects and vital signs, adjusted medication or placebo dosage (based on plasma levels reported by NYSPI and adverse effects), and completed clinical ratings. To evaluate the adequacy of the blinding, patients guessed their treatment assignment as placebo, nortriptyline, or nortriptyline-lithium at study exit. Patients who dropped out of the study or relapsed were offered clinical care by a psychiatrist at the research site not affiliated with the study or the follow-up evaluation of the particular patient.

Time to relapse was the main outcome measure. The criteria for relapse were a mean HRSD score (continuous rater and study psychiatrist) of at least 16 that was maintained for at least 1 week (over 2 consecutive visits) and a mean absolute increase of at least 10 points at 2 consecutive visits relative to continuation trial baseline. These criteria reflected a clinical worsening for which most clinicians would abandon the current treatment in favor of an alternative.

At the pre-ECT evaluation, a research nurse completed ratings on the Cumulative Illness Rating Scale⁵⁵ to assess medical comorbidity. At all major time points (pre-ECT, post-ECT, start of continuation trial [day 0], week 12, week 24, and relapse), the HRSD, Clinical Global Impression,⁵⁶ and Global Assessment Scale43 scores were completed by the continuous rater and the study psychiatrist. At each site, intraclass correlation coefficients for the 2 raters exceeded 0.97, 0.93, and 0.90 for HRSD, Clinical Global Impression, and Global Assessment Scale scores, respectively. A site-independent, time-blind clinician at NYSPI rated 239 videotapes of continuous rater interviews conducted at random intervals during the ECT and continuation phases. The intraclass correlation coefficients were 0.97, 0.96, and 0.95 for HRSD, Clinical Global Impression, and Global Assessment Scale scores, respectively. The HRSD, Clinical Global Impression, and Global Assessment Scale scores reported below are the continuous rater evaluations.

At each visit in the continuation phase, a blinded study psychiatrist completed the Treatment Emergent Symptom Scale.⁵⁶ Forty-eight possible adverse effects were rated for severity, relationship to study medication, and action taken. Clinically significant adverse effects were defined as those rated as moderate in severity, possibly related to study medication, and, at minimum, those requiring increased surveillance.

Statistical Methods

Patients who met remitter criteria following ECT and who did or did not participate in the continuation trial were compared in demographic, clinical, and previous treatment features with t tests for continuous measures and ^≤2 analyses for dichotomous variables. The randomized continuation pharmacotherapy groups were compared on baseline variables using analyses of variance or ^≤2 analyses.

The primary analysis of the continuation trial used survival analysis for right-censored failure-time data. A simultaneous regression model was fit to the relapse-time data using the Weibull distribution.10, 15 Covariates in the regression model were the randomized treatment condition (3 levels), strata (3 levels), sex, and HRSD score at the start of the trial. In a secondary analysis, ECT treatment modality (right unilateral only vs right unilateral and bilateral ECT vs bilateral ECT only) and number of ECT treatments were added as additional covariates. To confirm the findings from the parametric analysis regarding treatment group differences, nonparametric estimates of the survival distribution function for each group were computed, using the Kaplan-Meier method57 and contrasted with the log-rank test (Mantel-Cox).58

Early in the study, 1 site (Carrier Foundation) was closed when the hospital discontinued its research division, so another site (University of Iowa) was added late. These 2 sites entered 21 patients in the continuation trial compared with 63 patients at WPIC. To determine whether the effects were not unique to WPIC, the Carrier Foundation and the University of Iowa were pooled for analysis. A site term (WPIC vs Carrier Foundation and University of Iowa) was entered into both secondary parametric and nonparametric survival analyses.

To assess the adequacy of pharmacotherapy, separate analyses of variances were conducted on the last plasma levels for nortriptyline and lithium obtained in completers (24-week or time of relapse), using the assayed values for active medication and the simulated values for placebo, and treatment group (3 levels) and relapse status as between-subject factors. A logistic regression was conducted on the patients' guess of treatment condition with relapse status and actual treatment assignment as predictors.

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RESULTS

Of the 290 patients who completed the ECT phase, 159 (54.8%) patients were remitters (Table 1 and Figure 1). There was no difference among the sites in remitter rate (^≤222=3.75, P=.15). Immediately following ECT, 17 patients (5.9%) met initial remitter criteria, but not at the 4- to 8-day reassessment. The remitter rate may have been negatively influenced by the stringency of the remission criteria and the fact that 262 patients (90.3%) started with right unilateral ECT, with the minimum dosage only 150% above seizure threshold. Subsequent research has shown that the efficacy of right unilateral ECT improves at a higher dosage relative to seizure threshold.15, 59

Of the 159 remitters, 84 (52.8%) patients entered the randomized continuation trial. Of the 75 remitters who did not participate, 22.7% had medical exclusions for nortriptyline or lithium; 26.7% had travel limitations; and 50.7% preferred treatment by their referring physician, were receiving other medications or ECT, or were unwilling to receive placebo.

Comparisons of remitters who did or did not enter the continuation trial yielded no differences in pre- or post-ECT HRSD, Clinical Global Impression, or Global Assessment Scale scores, number of episodes, duration of current episode, number of ECT treatments, strength of the most potent antidepressant trial during the index episode, sum or average potency of all trials, number of trials, or number of adequate trials. The groups also did not differ in sex, race, history of previous ECT, use of right unilateral or bilateral ECT, or classification of medication resistance. Trial participants were younger (mean [SD], 57.4 [17.2] years) than nonparticipants (64.2 [16.3] years) (t₁₅₇=2.54; P=.01); had more previous psychiatric hospitalizations (2.4 [2.6]) than nonparticipants (1.5 [1.6]) (t₁₅₇=2.82; P=.005); a higher rate of psychotic depression (41.7% vs 16.0%) (^≤2₁=12.54, P <.001); and less total medical burden (Cumulative Illness Rating Scale score, 6.1 [4.2] vs 8.0 [3.9]) (t₁₅₇=2.91; P=.004). The medical exclusions for the continuation trial and travel limitations likely accounted for the higher age and greater medical burden of nonparticipants.

The continuation treatment groups were compared in demographic and clinical features (Table 2). There were no significant differences.

Eleven (13.1%) of the 84 patients dropped out of the trial before completing 24 weeks or meeting relapse criteria. The reasons for noncompletion are described in Figure 1. Dropout rates were evenly distributed among the 3 treatment groups (4 placebo, 2 nortriptyline, and 5 nortriptyline-lithium).

The overall model in the parametric analysis on survival time was significant (likelihood ratio, ^≤2₆=27.3; P<.001) (Table 3). The treatment groups differed markedly (P<.001). Both nortriptyline alone (P=.01) and nortriptyline-lithium (P<.001) were superior to placebo in survival time, and nortriptyline-lithium was superior to nortriptyline alone (P=.04).

The Kaplan-Meier survival function was computed for each treatment group (Figure 2). Across the sample, 45 (61.6%) of 73 completers relapsed. This confirmatory nonparametric analysis yielded a log-rank ^≤2₂ of 9.12 (P=.01). The relapse rates for completers were 84.0% (21/25) for placebo (95% confidence interval [CI], 70%-99%); 60.0% (15/25) for nortriptyline (95% CI, 41%-79%); and 39.1% (9/23) for nortriptyline-lithium (95% CI, 19%-59%). Only 1 patient relapsed while taking nortriptyline-lithium after 5 weeks, while relapse steadily continued with placebo and nortriptyline throughout the 24-week trial (Figure 2). Nonparametric survival analyses comparing each active treatment condition with placebo yielded a significant effect for nortriptyline-lithium (^≤2₁=8.52; P=.004), but only a trend for nortriptyline (^≤2₁=3.33; P=.07).

The parametric survival analysis indicated that across the treatment conditions, medication-resistant nonpsychotic patients had a higher relapse rate than patients with psychotic depression. The relapse rates were 50.0% for psychotic patients (n=28), 55.6% for nonpsychotic patients without medication resistance (n=9), and 72.2% for nonpsychotic medication-resistant patients (n=36). The significant effect of sex was due to a higher relapse rate among women (77.8%) than men (53.6%). Patients who relapsed had higher mean (SD) HRSD scores at trial entry (6.0 [3.1]) than patients who did not relapse (5.0 [2.8]). There were no additional significant effects in the parametric survival analysis when treatment with right unilateral, right unilateral and bilateral, or bilateral ECT (P=.89), and number of ECT treatments (P=.96) were entered as additional terms.

Study site (WPIC vs combined Carrier Foundation and University of Iowa) was entered as a term in both the parametric and nonparametric survival analyses. There were no site effects. The relapse rates at WPIC for placebo, nortriptyline, and nortriptyline-lithium were 88.9%, 60.0%, and 41.2%, respectively, and for the combined Carrier Foundation and University of Iowa they were 71.4%, 60.0%, and 33.3%, respectively.

The high rate of relapse across the treatments could have been due to excessively sensitive relapse criteria. Clinical ratings at continuation trial entry and end point were compared as a function of relapse status. Relapsed patients showed marked symptomatic worsening. Fifteen (33%) of the 45 relapsed patients were hospitalized and received ECT, 6 patients (13%) received outpatient ECT, and all other relapsed patients (53%) were switched to other pharmacotherapies. The severity of relapse did not differ among the continuation treatments.

No effects approached significance in the analyses of variances of nortriptyline and lithium levels on final visit. At final visit, the mean (SD) nortriptyline level was 89.9 (38.2) ng/mL for the nortriptyline group, 89.2 (32.2) ng/mL for the nortriptyline-lithium group, and the simulated levels reported for the placebo group averaged 93.0 (27.5) ng/mL. For lithium, the levels were 0.59 (0.2) mEq/L for the nortriptyline-lithium group, with simulated levels of 0.54 (0.2) mEq/L and 0.62 (0.2) mEq/L for the nortriptyline and placebo groups, respectively. Relapse was not associated with nortriptyline or lithium plasma levels.

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A 1-way analysis of variance indicated that the treatment groups did not differ in the average number of clinically significant adverse effects (F_2,80=0.13; P=.88). For the placebo, nortriptyline, and nortriptyline-lithium groups, the mean (SD) number of significant adverse effects per patient was 1.24 (1.8), 1.42 (1.7), and 1.21 (1.3), respectively. An analysis of variance in the completer sample (with treatment group and relapse status as between-subject factors) yielded no significant effects. The mean (SD) number of significant adverse effects among patients who relapsed (1.48 [1.7]) did not differ from nonrelapsed patients (1.32 [1.6]) (t₇₀=0.39; P=.70). Table 5 presents the clinically significant adverse effects experienced by at least 3 patients.

At study exit, 63 of the 73 completers guessed their treatment assignment. The logistic regression analysis yielded a modest association between the treatment assignment and the patients' guesses (^≤2₄=9.68; P=.05) and a more robust association with relapse status (^≤2₂=8.17; P=.02). Only 1 (4%) of the 25 patients who did not relapse believed he/she was treated with placebo, while this was true of 16 (42.1%) of the 38 patients who did relapse. Of the patients treated with placebo, 50% believed they received only placebo, while 31.8% and 18.2% believed that they had received nortriptyline and nortriptyline-lithium, respectively. For the nortriptyline group, the guesses were 29.4% for placebo, 23.8% for nortriptyline, and 52.4% for nortriptyline-lithium. For nortriptyline-lithium, these guesses were 5.0%, 30.0%, and 65.0%, respectively. While the patient blinding was imperfect, relapse status was a more powerful determinant of the guesses. The distributions overlapped considerably among patients treated with nortriptyline and nortriptyline-lithium.

COMMENT

Early research, based on first-choice use of ECT for major depression, indicated that half of the patients remain well in the 6 months following response without continuation therapy.16-18 We found that the relapse rate for placebo-treated patients was 84%. This suggests that the prognosis following ECT is more guarded today. Given the shift in use of ECT for severe, recurrent, and medication-resistant patients with higher risk of relapse,8, 15, 60 almost universal relapse should be expected without effective continuation therapy.

The early research suggested that continuation monotherapy with a TCA reduced the relapse rate to approximately 20%.16-18 We found that the relapse rate with nortriptyline continuation monotherapy was 60%, above the original projections for placebo. While TCAs are believed to be among the most effective antidepressant agents,27, 30, 33 our findings indicate that the efficacy of post-ECT TCA continuation monotherapy is not acceptable. Similarly, in a naturalistic study, Flint and Rifat⁶¹ found that continuation monotherapy with a TCA was ineffective in preventing relapse in psychotically depressed patients who responded to ECT.

The relapse rate for the combination of nortriptyline-lithium was 39.1%, which was superior to placebo and nortriptyline monotherapy. Similar results were reported in a naturalistic study at NYSPI, in which relapse rates over 1 year were markedly lower among ECT remitters who received TCA-lithium continuation therapy (35.3%) compared with patients who received continuation treatment with other pharmacological regimens (67.9%).15 It was noteworthy that the lithium levels in the present study were at the low end of what is considered the therapeutic range for acute or maintenance treatment (0.5-1.2 mEq/L).62, 63 This suggests that in combination with nortriptyline, lithium levels may only need to be greater than 0.5 mEq/L to prevent post-ECT relapse.

This study could not determine whether the advantage of the TCA-lithium combination was due to lithium alone or the synergism of lithium with the TCA. The only placebo-controlled trial of lithium following ECT in unipolar patients found that lithium did not have protective effects during the first 6 months following ECT.64, 65 Thus, it is likely that the advantage of nortriptyline-lithium was due to additive or synergistic effects and not lithium alone. Our findings encourage the use of nortriptyline-lithium as post-ECT continuation therapy. It is unknown whether similar protective effects would be obtained with a mood stabilizer other than lithium or antidepressants other than nortriptyline (in combination with lithium). This issue is important since SSRIs and other newer antidepressant agents have better tolerability than TCAs and are now more commonly used.

Patients with higher HRSD scores at the start of the continuation trial had shorter survival time. This is consistent with several studies of relapse during continuation pharmacotherapy following response to antidepressant medications 46, 47 or ECT.8 Thus, concerted attempts should be made to maximize symptomatic improvement in patients receiving ECT. Women were more prone to relapse during the continuation phase. There is inconsistent evidence from naturalistic studies of a higher relapse/recurrence rate among women.14, 66-70 Studies of patients with psychotic depression suggested a high post-ECT relapse rate.6, 7 However, regardless of the treatment producing remission, no previous controlled study has compared relapse rates in psychotic and nonpsychotic depressed patients. We found that psychotically depressed patients had a lower relapse rate than medication-resistant nonpsychotic patients. Several studies have shown that medication resistance is especially predictive of post-ECT relapse.8, 15, 60 It is also possible that compared with medication-resistant nonpsychotic patients, patients with psychotic depression had less Axis II (personality disorder) pathology and better interepisode function. There is evidence that the post-ECT course is poorer in patients with significant Axis II pathology.71, 72

The major finding was that treatment with the nortriptyline-lithium combination produced a substantially lower relapse rate than treatment with placebo or nortriptyline alone. Nonetheless, the relapse with nortriptyline-lithium was high (39.1%). Two alternative strategies, which are not mutually exclusive, should be tested.4 Both strategies are suggested by the observations that relapse is heavily skewed to the period immediately following ECT. During the acute treatment phase, there is a several week delay before antidepressant and mood stabilizing agents exert therapeutic effects.⁷³ Further, the abrupt discontinuation of effective somatic treatment is associated with potentiation of relapse,^74-76 which is standard in terminating an ECT course. One strategy is to taper ECT over a few weeks, as is commonly done with pharmacological treatments, providing symptom suppression during the most vulnerable period. Second, the antidepressant medication used in continuation therapy may be started during the course of ECT, followed by post-ECT addition of lithium. All controlled studies in which ECT was combined with an antidepressant medication focused on whether response to ECT was improved,16-19 and not whether this strategy reduced post-ECT relapse. Nonetheless, a low post-ECT relapse rate was seen in studies in which patients began taking an antidepressant at the start of the ECT course.16-19 Thus, these 2 adjunctive strategies raise the possibility that the advantage seen with the nortriptyline-lithium therapy may be further improved and that the problem of the high rate of early relapse with continuation pharmacotherapy following ECT could be resolved.

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Author/Article Information

Author Affiliations: Departments of Biological Psychiatry (Drs Sackeim and Prudic), Neuroscience (Dr Mann), and Analytical Psychopharmacology (Mr Cooper), New York State Psychiatric Institute, and the Departments of Psychiatry (Drs Sackeim, Mann, and Prudic and Mr Cooper) and Radiology (Drs Sackeim and Mann), College of Physicians and Surgeons, Columbia University, New York, NY; Western Psychiatric Institute and Clinic and the Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pa (Drs Haskett, Mulsant, and Thase); Carrier Foundation, Belle Meade, NJ (Drs Pettinati and Greenberg); Department of Psychiatry, University of Iowa, Iowa City (Dr Crowe). Dr Pettinati is now with the Department of Psychiatry, University of Pennsylvania, Philadelphia; Dr Greenberg, the Department of Psychiatry, St Francis Hospital, Jersey City, NJ.

Corresponding Author and Reprints: Harold A. Sackeim, PhD, Department of Biological Psychiatry, New York State Psychiatric Institute, 1051 Riverside Dr, New York, NY 10032 (e-mail: has1@columbia.edu).

Author Contributions: Study concept and design: Sackeim, Haskett, Mann, Pettinati, Cooper, Prudic.

Acquisition of data: Haskett, Mulsant, Mann, Pettinati, Greenberg, Crowe, Prudic.

Analysis and interpretation of data: Sackeim, Haskett, Mulsant, Thase, Cooper.

Drafting of the manuscript: Sackeim, Mann.

Critical revision of the manuscript for important intellectual content: Sackeim, Haskett, Mulsant, Thase, Mann, Pettinati, Greenberg, Crowe, Cooper, Prudic.

Statistical expertise: Sackeim.

Obtained funding: Sackeim, Haskett, Mann, Pettinati, Prudic.

Administrative, technical, or material support: Sackeim, Haskett, Mulsant, Thase, Mann, Pettinati, Cooper, Prudic.

Study supervision: Sackeim, Haskett, Mulsant, Thase, Mann, Pettinati, Prudic.

Funding/Support: This work was supported by National Institute of Mental Health grants R37 MH35636 (Dr Sackeim), R10 MH57009 (Dr Sackeim), R01 MH47739 (Dr Sackeim), R01 MH48512 (Dr Haskett), R01 MH49786 (Dr Mulsant), R01 MH52247 (Dr Mulsant), R01 MH 01613 (Dr Mulsant), R01 MH30915 (Dr Thase), R10 MH57804 (Dr Crowe), and R01 MH47709 (Dr Pettinati). The lithium carbonate used in this study was obtained through a grant from Solvay Pharmaceuticals Inc (Marietta, Ga). The electroconvulsive therapy devices used in this study were donated by the MECTA Corp.

Acknowledgment: We thank James J. Amos, MD, Donald W. Black, MD, Robert Dealy, MD, Diane Dolata, MSW, RN, Jennifer Dean, BA, Tracy Flynn, MEd, Janelle Gabel, RN, Stephen J. Hegedus, BS, Kevin M. Malone, MD, Mitchell S. Nobler, MD, Carrie J. Opheim, BS, Shoshana Peyser, CSW, PhD, Steven P. Roose, MD, Kerith E. Spicknall, BA, and Stephanie M. Stevens, RN, for assistance in carrying out this study.

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REFERENCES

1-15 ~ 16-30 ~ 31-45 ~ 46-60 ~ 61-75

1.
American Psychiatric Association Committee on Electroconvulsive Therapy.
The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training, and Privileging.
2nd ed. Washington, DC: American Psychiatric Association; 2001.

2.
Thompson JW, Weiner RD, Myers CP.
Use of ECT in the United States in 1975, 1980, and 1986.
Am J Psychiatry.
1994;151:1657-1661.
MEDLINE

3.
Sackeim HA, Devanand DP, Nobler MS.
Electroconvulsive therapy.
In: Bloom F, Kupfer D, eds. Psychopharmacology: The Fourth Generation of Progress. New York, NY: Raven; 1995:1123-1142.

4.
Sackeim HA.
Continuation therapy following ECT: directions for future research.
Psychopharmacol Bull.
1994;30:501-521.
MEDLINE

5.
Karlinsky H, Shulman KI.
The clinical use of electroconvulsive therapy in old age.
J Am Geriatr Soc.
1984;32:183-186.

6.
Spiker DG, Stein J, Rich CL.
Delusional depression and electroconvulsive therapy: one year later.
Convulsive Ther.
1985;1:167-172.

7.
Aronson TA, Shukla S, Hoff A.
Continuation therapy after ECT for delusional depression: a naturalistic study of prophylactic treatments and relapse.
Convulsive Ther.
1987;3:251-259.

8.
Sackeim HA, Prudic J, Devanand DP, et al.
The impact of medication resistance and continuation pharmacotherapy on relapse following response to electroconvulsive therapy in major depression.
J Clin Psychopharmacol.
1990;10:96-104.

9.
Malcolm K, Dean J, Rowlands P, Peet M.
Antidepressant drug treatment in relation to the use of ECT.
J Psychopharmacol.
1991;5:255-258.

10.
Sackeim HA, Prudic J, Devanand DP, et al.
Effects of stimulus intensity and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy.
N Engl J Med.
1993;328:839-846.

11.
Grunhaus L, Shipley JE, Eiser A, et al.
Shortened REM latency post-ECT is associated with rapid recurrence of depressive symptomatology.
Biol Psychiatry.
1994;36:214-222.

12.
Lemstra A, Leentjens AF, van den Broek WW.
Temporary results only in electroconvulsive therapy in therapy-resistant depression: retrospective study.
Ned Tijdschr Geneeskd.
1996;140:260-264.

13.
O'Leary DA, Lee AS.
Seven-year prognosis in depression: mortality and readmission risk in the Nottingham ECT cohort.
Br J Psychiatry.
1996;169:423-429.

14.
Flint AJ, Rifat SL.
Two-year outcome of psychotic depression in late life.
Am J Psychiatry.
1998;155:178-183.

15.
Sackeim HA, Prudic J, Devanand DP, et al.
A prospective, randomized, double-blind comparison of bilateral and right unilateral electroconvulsive therapy at different stimulus intensities.
Arch Gen Psychiatry.
2000;57:425-434.

16.
Seager CP, Bird RL.
Imipramine with electrical treatment in depression: a controlled trial.
J Ment Sci.
1962;108:704-707.

17.
Imlah NW, Ryan E, Harrington JA.
The influence of antidepressant drugs on the response to electroconvulsive therapy and on subsequent relapse rates.
Neuropsychopharmacology.
1965;4:438-442.

18.
Kay DW, Fahy T, Garside RF.
A seven-month double-blind trial of amitriptyline and diazepam in ECT-treated depressed patients.
Br J Psychiatry.
1970;117:667-671.

19.
Lauritzen L, Odgaard K, Clemmesen L, et al.
Relapse prevention by means of paroxetine in ECT-treated patients with major depression: a comparison with imipramine and placebo in medium-term continuation therapy.
Acta Psychiatr Scand.
1996;94:241-251.

20.
Abou-Saleh MT, Coppen AJ.
Continuation therapy with antidepressants after electroconvulsive therapy.
Convulsive Ther.
1988;4:263-268.

21.
American Psychiatric Association Committee on Electroconvulsive Therapy.
The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training and Privileging.
Washington, DC: American Psychiatric Association; 1990.

22.
Royal College of Psychiatrists.
The ECT Handbook: The Second Report of the Royal College of Psychiatrists' Special Committee on ECT.
London, England: Royal College of Psychiatrists; 1995.

23.
Abrams R.
Electroconvulsive Therapy.
3rd ed. New York, NY: Oxford University Press; 1997.

24.
Sackeim HA, Prudic J, Devanand DP.
Treatment of medication-resistant depression with electroconvulsive therapy.
In: Tasman A, Goldfinger SM, Kaufmann CA, eds. Annual Review of Psychiatry. Vol 9. Washington, DC: American Psychiatric Press; 1990:91-115.

25.
Medical Research Council.
Clinical trial of the treatment of depressive illness: report to the Medical Research Council by its Clinical Psychiatry Committee.
BMJ.
1965;1:881-886.

26.
Sargant W, Slater E.
An Introduction to Physical Methods of Treatment in Psychiatry.
Baltimore, Md: Williams & Wilkins; 1964.

27.
Flint AJ, Rifat SL.
The effect of sequential antidepressant treatment on geriatric depression.
J Affect Disord.
1996;36:95-105.

28.
Danish University Antidepressant Group (DUAG).
Citalopram: clinical effect profile in comparison with clomipramine: a controlled multicenter study.
Psychopharmacology.
1986;90:131-138.

29.
Andersen IM, Tomenson BM.
The efficacy of selective serotonin reuptake inhibitors in depression: a meta-analysis of studies against tricyclic antidepressants.
J Psychopharmacol.
1994;8:238-249.

30.
Roose SP, Glassman AH, Attia E, Woodring S.
Comparative efficacy of selective serotonin reuptake inhibitors and tricyclics in the treatment of melancholia.
Am J Psychiatry.
1994;151:1735-1739.

31.
Reimherr F, Wood D, Byerley B, Brainard J, Grosser B.
Characteristics of responders to fluoxetine.
Psychopharmacol Bull.
1984;20:70-72.

32.
Tignol J, Stoker M, Dunbar G.
Paroxetine in the treatment of melancholia and severe depression.
Int Clin Psychopharmacol.
1992;7:91-94.

33.
Danish University Antidepressant Group (DUAG).
Paroxetine: a selective serotonin reuptake inhibitor showing better tolerance, but weaker antidepressant effect than clomipramine in a controlled multicenter study.
J Affect Disord.
1990;18:289-299.

34.
Prudic J, Haskett RF, Mulsant B, et al.
Resistance to antidepressant medications and short-term clinical response to ECT.
Am J Psychiatry.
1996;153:985-992.

35.
de Montigny C, Cournoyer G, Morissette R, Langlois R, Caille G.
Lithium carbonate addition in tricylic antidepressant-resistant unipolar depression.
Arch Gen Psychiatry.
1983;40:1327-1334.

36.
Dinan TG, Barry S.
A comparison of electroconvulsive therapy with a combined lithium and tricyclic combination among depressed tricyclic nonresponders.
Acta Psychiatr Scand.
1989;80:97-100.

37.
Bruijn JA, Moleman P, Mulder PG, van den Broek WW.
Comparison of 2 treatment strategies for depressed inpatients: imipramine and lithium addition or mirtazapine and lithium addition.
J Clin Psychiatry.
1998;59:657-663.

38.
Heninger GR, Carney DS, Sternberg DE.
Lithium carbonate augmentation of antidepressant treatment: an effective prescription for treatment-refractory depression.
Arch Gen Psychiatry.
1983;40:1335-1342.

39.
Joffe RT, Singer W, Levitt AJ, MacDonald C.
A placebo-controlled comparison of lithium and triiodothyronine augmentation of tricyclic antidepressants in unipolar refractory depression.
Arch Gen Psychiatry.
1993;50:387-393.

40.
Kantor D, McNevin S, Leichner P, Harper D, Krenn M.
The benefit of lithium carbonate adjunct in refractory depression: fact or fiction?
Can J Psychiatry.
1986;31:416-418.

41.
Thase ME, Kupfer DJ, Frank E, Jarrett DB.
Treatment of imipramine-resistant recurrent depression, II: an open clinical trial of lithium augmentation.
J Clin Psychiatry.
1989;50:413-417.

42.
Mulsant BH, Haskett RF, Prudic J, et al.
Low use of neuroleptic drugs in the treatment of psychotic major depression.
Am J Psychiatry.
1997;154:559-561.

43.
Endicott J, Spitzer RL.
A diagnostic interview: the Schedule for Affective Disorders and Schizophrenia.
Arch Gen Psychiatry.
1978;35:837-844.

44.
Spitzer RL, Endicott J, Robins E.
Research diagnostic criteria: rationale and reliability.
Arch Gen Psychiatry.
1978;35:773-782.

45.
Hamilton M.
Development of a rating scale for primary depressive illness.
Br J Soc Psychol.
1967;6:278-296.

46.
Prien R, Kupfer D.
Continuation drug therapy for major depressive episodes: how long should it be maintained?
Am J Psychiatry.
1986;143:18-23.

47.
Prien RF, Koscis JH.
Long-term treatment of mood disorders.
In: Bloom FE, Kupfer DJ, eds. Psychopharmacology: The Fourth Generation of Progress. New York, NY: Raven; 1995:1067-1080.

48.
d'Elia G.
Unilateral electroconvulsive therapy.
Acta Psychiatr Scand.
1970;215(suppl):1-98.

49.
Sackeim HA, Decina P, Prohovnik I, Malitz S.
Seizure threshold in electroconvulsive therapy: effects of sex, age, electrode placement, and number of treatments.
Arch Gen Psychiatry.
1987;44:355-360.

50.
Prudic J, Sackeim HA, Devanand DP.
Medication resistance and clinical response to electroconvulsive therapy.
Psychiatry Res.
1990;31:287-296.

51.
Fleiss JL.
The Design and Analysis of Clinical Experiments.
New York, NY: John Wiley & Sons; 1986.

52.
Cooper TB, Simpson GM.
Prediction of individual dosage of nortriptyline.
Am J Psychiatry.
1978;135:333-335.

53.
Cooper TB, Simpson GM.
The 24-hour lithium level as a prognosticator of dosage requirements: a 2-year follow-up study.
Am J Psychiatry.
1976;133:440-443.

54.
Cooper TB, Simpson GM.
Issues related to the prediction of optimum dosage.
In: Cooper TB, Gershon S, Kline NS, Schou M, eds. Lithium: Controversies and Unresolved Issues. Amsterdam, the Netherlands: Excerpta Medica; 1979:346-353.

55.
Miller MD, Paradis CF, Houck PR, et al.
Rating chronic medical illness burden in geropsychiatric practice and research: application of the Cumulative Illness Rating Scale (CIRS).
Psychiatry Res.
1992;41:237-248.

56.
Guy W.
ECDEU Assessment Manual for Psychopharmacology.
Washington, DC: Superintendent of Documents, US Government Printing Office, US Dept of Health, Education, and Welfare; 1976. Publication 76-338.

57.
Kalbfleisch JD, Prentice RL.
Survival Models and Data Analysis.
New York, NY: John Wiley; 1980.

58.
Peto R, Peto J.
Asymptomatically efficient rank invariant procedure.
J R Stat Soc Ser A.
1972;135:185-207.

59.
McCall WV, Reboussin DM, Weiner RD, Sackeim HA.
Titrated moderately suprathreshold vs fixed high-dose right unilateral electroconvulsive therapy: acute antidepressant and cognitive effects.
Arch Gen Psychiatry.
2000;57:438-444.

60.
Shapira B, Gorfine M, Lerer B.
A prospective study of lithium continuation therapy in depressed patients who have responded to electroconvulsive therapy.
Convuls Ther.
1995;11:80-85.

61.
Flint AJ, Rifat SL.
The effect of treatment on the two-year course of late-life depression.
Br J Psychiatry.
1997;170:268-272.

62.
Steering Committee of the American Psychiatric Association.
The Expert Consensus Guideline Series: treatment of bipolar disorder.
J Clin Psychiatry.
1996;57(suppl 12A):3-88.

63.
American Psychiatric Association.
Practice guideline for the treatment of patients with bipolar disorder.
Am J Psychiatry.
1994;151(12 suppl):1-36.

64.
Coppen A, Abou-Saleh MT, Milln P, et al.
Lithium continuation therapy following electroconvulsive therapy.
Br J Psychiatry.
1981;139:284-287.

65.
Abou-Saleh MT.
How long should drug therapy for depression be maintained?
Am J Psychiatry.
1987;144:1247-1248.

66.
Sargeant JK, Bruce ML, Florio LP, Weissman MM.
Factors associated with 1-year outcome of major depression in the community.
Arch Gen Psychiatry.
1990;47:519-526.

67.
Black DW, Goldstein RB, Nasrallah A, Winokur G.
The prediction of recovery using a multivariate model in 1471 depressed inpatients.
Eur Arch Psychiatry Clin Neurosci.
1991;241:41-45.

68.
Ernst C, Angst J.
The Zurich Study, XII: sex differences in depression: evidence from longitudinal epidemiological data.
Eur Arch Psychiatry Clin Neurosci.
1992;241:222-230.

69.
Kessler RC, McGonagle KA, Swartz M, Blazer DG, Nelson CB.
Sex and depression in the National Comorbidity Survey, I: lifetime prevalence, chronicity and recurrence.
J Affect Disord.
1993;29:85-96.

70.
Simpson HB, Nee JC, Endicott J.
First-episode major depression: few sex differences in course.
Arch Gen Psychiatry.
1997;54:633-639.

71.
Zimmerman M, Coryell W, Pfohl B, Corenthal C, Stangl D.
ECT response in depressed patients with and without a DSM-III personality disorder.
Am J Psychiatry.
1986;143:1030-1032.

72.
Sareen J, Enns MW, Guertin JE.
The impact of clinically diagnosed personality disorders on acute and one-year outcomes of electroconvulsive therapy.
J ECT.
2000;16:43-51.

73.
Hyman SE, Nestler EJ.
Initiation and adaptation: a paradigm for understanding psychotropic drug action.
Am J Psychiatry.
1996;153:151-162.

74.
Suppes T, Baldessarini RJ, Faedda GL, Tohen M.
Risk of recurrence following discontinuation of lithium treatment in bipolar disorder.
Arch Gen Psychiatry.
1991;48:1082-1088.

75.
Baldessarini RJ, Tondo L, Faedda GL, Suppes TR, Floris G, Rudas N.
Effects of the rate of discontinuing lithium maintenance treatment in bipolar disorders.
J Clin Psychiatry.
1996;57:441-448.

76.
Reynolds CF III, Frank E, Perel JM, et al.
High relapse rate after discontinuation of adjunctive medication for elderly patients with recurrent major depression.
Am J Psychiatry.
1996;153:1418-1422.

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His New Battle
Patient takes fight against electric shock treatment to court

Paul Henri Thomas, a former Haitian human rights activist, is now an American citizen championing a different cause: the right of psychiatric patients to refuse forced electric shock therapy.

As in Haiti, he counts himself among the oppressed here. Thomas, 49, has been a patient at Pilgrim Psychiatric Center in Central Islip for the past 22 months, where he has received shock therapy between 30 and 50 times.

Pilgrim psychiatrists say he needs to be shocked because he has schizophrenic affective disorder, a form of psychosis that in Thomas' case shows itself through manic, delusional behavior.

Thomas says he's fine. He's not mentally ill, so he doesn't need shock treatment, he says. If anything, Thomas says, shock treatment makes his life worse.

"After the treatment, it is just as if I came back from nowhere," Thomas said during a court hearing Friday. "I am surprised I am myself... It is not a pleasant experience."

The hearing was held to determine whether Thomas is psychologically competent to refuse shock therapy. If state Supreme Court Justice W. Bromley Hall determines he is competent, the focus of the hearing will turn to whether shock treatment is appropriate for Thomas. If Hall decides Thomas is not competent, the hospital may proceed with therapy, despite Thomas' wishes.

Thomas and his plight have become an international cause. Anti-shock therapy Web sites urge viewers to rally behind him.

Friday's hearing took place in a cramped courtroom in Building 69 on the Pilgrim campus. About 30 activists, some from as far away as Syracuse, gathered outside. Although Thomas waived his privacy rights and Hall assured the public it could attend, state Office of Mental Health officials made the activists unwelcome.

Pilgrim police officers made them stand outside in the snow for hours until court was in session and then allowed only five to sit in the courtroom. Pilgrim police also threatened news photographers with arrest if they took pictures on campus. Police followed a group of activists to make sure they were photographed beyond Pilgrim's property line.

Dr. Robert Kalani, Pilgrim's associate medical director and the director of electroconvulsive therapy there, testified that Thomas came to Pilgrim in May 1999 when he became unmanageable at South Nassau Community Hospital in Oceanside.

Thomas' psychiatric problems date to 1977, when he had a breakdown while living in Haiti.

Kalani said shock treatment is appropriate for Thomas because years of taking psychotropic drugs have damaged his liver. Thomas still takes 3,000 milligrams of Depakote and 1,200 milligrams of lithium a day. Depakote and lithium are mood stabilizers.

During questioning by Assistant Attorney General Laurie Gatto, Kalani said Thomas is not competent to decline shock treatment. Evidence of that is Thomas' belief that he's not even mentally ill, Kalani said.

"He does not appreciate the consequences of refusing treatment," Kalani said.

Kalani also said Thomas' illness is apparent in how he communicates. He has "pressured speech" -- he speaks rapidly -- and needs to be frequently redirected or else his answers to questions quickly ramble off the topic. For example, Thomas responded to one question during an interview about how he was functioning by listing his educational background, Kalani said.

But Thomas' attorney, Kim Darrow of the state Mental Hygiene Legal Services, suggested that Thomas gave his education as an example of how well he was functioning.

But Thomas' own sister, Mary Ann Pierre-Louis of Elmont, testified that he cannot function in society. Before his transfer to Pilgrim, Pierre-Louis said, Thomas was out of control.

"He was playing with his feces," she said. "He said he was doing an experiment."

Later during the hearing, Thomas said he didn't recall that, adding that if he had been experimenting with feces he would have known enough to have worn latex gloves.

"My brother is sick," she said. "We know it. My brother is very ill."

Thomas' answers on the witness stand were frequently elliptical, often unrelated to the question and sometimes completely incoherent. At times Darrow struggled to follow his client's answers.

"What are we talking about now?" Darrow said in confusion at one point.

Thomas' speech was slurred and his hands trembled, a result of the psychotropic medicine he took when he was younger, according to his doctors.

But Dr. Ron Leifer, a Syracuse psychiatrist hired by Darrow, testified that he agreed Thomas had no major mental illness.

"If he's suffering from delusions, so am I," Leifer said. "His speech is not disorganized, if you have the patience to listen to him. He always comes back to the point."

Thomas' refusal of shock therapy is well reasoned, Leifer said.

"Shock treatment is very unpleasant, and because he believes he's not mentally ill, it doesn't make any sense," Leifer said.

During cross-examination by Gatto, Leifer stood by his diagnosis and added that everyone suffers from some kind of personality disorder.

The hearing will continue next week.

---

Notes Say Shock Treatments Help Man

by Zachary R. Dowdy
Staff Writer
March 13, 2001

The scribblings of doctors and nurses tell a tale of Paul Henri Thomas, a man they say lapsed into delusions and harassed Pilgrim Psychiatric Center staff until he was given a jolt of electric shock therapy.

The contents of the "progress notes" read by Pilgrim's Dr. Robert Kalani at a hearing before State Supreme Court Justice W. Bromley Hall in Central Islip yesterday formed the bulk of the state's claim that Thomas is better off, and more manageable to staff, when he gets regular doses of electroconvulsive therapy.

The notes, dating from the time he was admitted to the facility in May 1999 through last month, consist of dozens of short reports of Thomas displaying "manic behavior," "pressured speech" and "agitation." Soon after shock treatment, though, the notes said, he was "much calmer," displayed "no acting out" and was "no longer manic." State Assistant Attorney General Laurie Gatto asked Kalani about Thomas' treatment and used Kalani's opinion and the progress notes to draw a direct link between Thomas' behavior and the shock treatment, which Thomas vigorously opposes.

Kalani said Thomas, 49, is afflicted with "bipolar mania with psychotic features," though Thomas' disorder had been diagnosed as "schizoaffective bipolar type with psychotic features," Gatto said.

The hearing will determine whether Thomas should be subject to the therapy against his will.

Thomas, whose psychiatric problems date to 1977 when he had a breakdown in Haiti, came to Pilgrim after he became unmanageable at Southside Community Hospital in Oceanside. His plight has become, for some, a symbolic fight for the preservation of a constitutional right to refuse treatment.

His doctors at Pilgrim, however, say he is sick, and unable to determine what is best for himself.

Pilgrim officials, backed by three court orders, won the right to administer the treatment, subjecting Thomas to up to 60 shocks over the past two years.

Thomas' attorney, Kim Darrow of the state's Mental Hygiene Legal Services, said his client has no mental illness and is healthy enough to be released.

He objected each time Kalani began to read through the progress notes that contained illegible signatures. And, in what may have been the most dramatic moment of the hearing, he said some of them were written to make the case that Thomas should continue to receive the treatment.

"These notes are made for the specific purpose of this litigation and should not be admitted as evidence," Darrow said. But his objection, like dozens of others, was overruled by Hall.

Darrow, who did not get a chance to cross-examine Kalani because the court day ended, also argued the notes make "conclusions" and statements that categorize Thomas' behavior without describing what specific acts he allegedly committed.

At a hearing earlier this month, Hall divided the case into two portions: to determine whether Thomas has the capacity to make health decisions for himself and to determine whether the controversial shock treatment is an appropriate method in his case.

The next hearing date could be set as early as today, and Hall said it will likely occur Thursday.

March 16, 2001

Mental Competence in Question Doctors: Man not fit to refuse shock treatment

In June 1, Paul Henri Thomas thought clearly enough to sign a consent form, giving his doctors permission to place electrodes near his temples and send jolts of electricity through his brain as part of his treatment at Pilgrim Psychiatric Center.

He underwent the painful and controversial electro- shock procedure three times, on June 9, 11 and 14. But after that third treatment, he had refused to submit to it again.

That's when his doctors began saying Thomas, 49, no longer had the mental capacity to make decisions on his own, so they obtained a court order to force the electroshock therapy upon him.

The revelation of a kind of Catch-22-the strange circumstance that Thomas was fine when he consented to the procedure but mentally incompetent when he refused it-took center stage at a hearing yesterday to determine whether doctors may again shock Thomas against his will.

Thomas, who has been a patient at Pilgrim since May 1, is challenging the state's application to continue giving him shock treatments-a controversial form of therapy to treat a variety of mental illnesses. Thomas contends he is not mentally ill.

At the third day of Thomas' hearing yesterday, his attorney questioned a witness for Pilgrim.

"In June he was competent to consent and received three treatments, and some time after that he became incompetent. Is that correct?" asked Kim Darrow, an attorney for the state Mental Hygiene Legal Service, which is representing Thomas.

"I'm unable to answer that," responded Dr. Robert Kalani, Pilgrim's associate medical director.

But State Supreme Court Justice W. Bromley Hall swiftly cut off Darrow's line of questioning, saying Thomas' capacity to make decisions about his health may have changed since he consented to the treatment.

"There are a lot of people walking around with capacity for whatever," Hall said in the Central Islip courtroom. "The fact that you have capacity today doesn't mean you will have capacity tomorrow," he added, prompting gasps from Thomas' supporters.

---

The proceeding marked the first time Darrow could cross-examine Kalani, who was testifying for Assistant Attorney General Laurie Gatto on Monday.

Gatto had made the case then that Thomas was perceived to be much more manageable during the periods when he was receiving shock treatments.

If Pilgrim officials are successful, they will be able to administer the treatment to Thomas, who is also on mood stabilizing drugs, despite his wishes.

The facility seeks authorization for 40 more shock treatments.

It would be the fourth time they have obtained court approval for the procedure on him. Thomas has already received at least 57 treatments over a two-year span without his consent.

Under questioning by Darrow, Kalani also admitted that on Feb. 1, he signed a form for a court order for additional treatments without first examining Thomas, an act that Darrow said was a violation of state rules regarding treatment of mental illness.

Darrow also said the affidavit submitted to the court for additional shock treatments was only a stock form with spaces for the date, patient's name, name of the doctor and the disorder. It had no specific details concerning the patient.

Darrow asked Kalani how he could sign off on such a form, but Kalani said he based his decision partly on a conversation he had with Thomas' physician.

Testimony ended with Darrow asking Kalani, given that Thomas has called the procedure "torture" and "evil," how has it improved his life.

"Do you think you have improved the quality of life for Mr. Thomas?"

"I think we have," Kalani answered.

The hearing will continue next week.

March 28, 2001

Man Says More Rights Violated

by Zachary R. Dowdy
Staff Writer

In recent weeks, Paul Henri Thomas has become Long Island's most visible and vocal opponent to electroshock treatment, a procedure he has undergone at Pilgrim Psychiatric Center nearly 60 times against his will since he was confined there in May 1999.

His fight against the treatment has spilled into public forums, including news media and the Internet, but most notably state Supreme Court in Central Islip, as he challenges the state's application to give him 40 more shocks.

He has called the procedure a form of "torture," claiming doctors at Pilgrim are violating his constitutional right to refuse the treatment.

Now, Thomas, 49, and his attorneys say Pilgrim officials are violating another basic right-freedom to speak his mind about electroshock treatment-by monitoring his conversations with people who visit him at Pilgrim in Central Islip. And, they say, the restrictions that have been imposed on Thomas are in retaliation for his efforts to publicize his plight.

"Under the guise of seeing whether he is competent to do such things as sign papers or have a conversation, they are providing obstacles for his free communication to the public about his views on what's happening to him," said Dennis Feld, deputy chief attorney for the state Mental Hygiene Legal Service, which is representing Thomas.

Jill Daniels, a spokeswoman for the state Office of Mental Health in Albany, declined to comment, citing ongoing litigation.

Feld, whose agency filed the lawsuit Friday in Federal Court, said Pilgrim officials have placed Thomas under so-called one-to-one observation. That designation means Thomas cannot sign papers or have a conversation with anyone outside of his family or attorneys without a Pilgrim staff member present.

Thomas, who Feld said receives visitors almost daily, seeks a declaration from the court that his rights were violated, an order barring the restrictions, in addition to attorney fees and monetary damages.

The one-to-one designation, Feld said, is normally applied to patients who have been "acting out," or who do not have the mental capacity to sign papers.

The lawsuit comes as State Supreme Court Justice W. Bromley Hall tries to decide whether Thomas has the capacity to refuse the treatment and whether shock treatment is appropriate therapy for him.

April 17, 2001

Judge Continues Electroshock

Saying that expert witnesses for Paul Henri Thomas were "simply not credible," a State Supreme Court justice yesterday gave Pilgrim Psychiatric Center the green light to resume the electroshock treatments Thomas had hoped to stop.

---

Justice W. Bromley Hall's seven-page decision comes more than two months after Pilgrim applied for a court order to administer 40 shock treatments to Thomas.

The judge approved the treatments and lifted a temporary injunction blocking three treatments Pilgrim had won the right to give by a previous court order.

Thomas, 49, who emigrated from Haiti in 1982, denies he has a mental illness, but doctors at Pilgrim testified he displays signs of several disorders including schizoaffective disorder and bipolar mania.

He has received nearly 60 electroconvulsive therapy treatments -- most of them against his will -- since he was committed to the institution in May 1999.

Hall's decision, which evaluates the weight of testimony from Thomas, his sister and expert witnesses, came as no surprise, according to the state attorney general's office which represented Pilgrim.

"The intensity of the objection by Mental Hygiene Legal Service [which represented Thomas] is the only thing that was surprising," said Assistant Attorney General Laurie Gatto.

Denis McElligott of the state attorney general's office said Thomas' case shows that electroshock treatments are forced upon a patient only after a thorough legal debate.

"We're hoping that the best thing that comes from this entire situation is the public's understanding that when this is done it is only done pursuant to a court order after a judge has heard all of the testimony," McElligott said.

But Dennis Feld, deputy chief attorney for the state Mental Hygiene Legal Service in Mineola, said Hall discredited Thomas' witnesses, tipping the scales against him. "The decision doesn't come as a surprise with the court discounting our experts' testimony," Feld said. "It leaves very little to be argued and to be guessed as to which way the court would go."

Kim Darrow, an attorney who argued the case for Thomas, was unavailable for comment yesterday.

Feld said his agency would appeal the decision once the attorney general's office drafts an order to administer the treatments.

Hall's decision came after many weeks of testimony from experts who fall on both sides of the controversial electroshock treatment issue.

The hearing was designed to answer two questions: Did Thomas possess the mental capacity to make medical decisions on his own and was this form of treatment, ­it is uncomfortable if not painful for some patients, has caused memory loss and is often followed by relapses -- the best treatment for Thomas?

Pilgrim doctors Robert Kalani, associate medical director, and Andre Azemar, Thomas' psychiatrist, both testified that Thomas badly needed the treatment, partly because drugs that would help him will further damage his liver.

They said he suffers from delusional thinking and is prone to behavior they consider bizarre.

"He has been found sitting on the floor comparing himself with Mahatma Gandhi," Hall wrote. "He was wearing three pairs of pants which he believed provided therapy for him. At the same time he was found, in the ward, wearing layers of shirts which were inside-out, together with jackets, gloves and sunglasses."

Hall dismissed the testimony of Ron Leifer, an Ithaca psychiatrist, and John McDonough, a psychologist, who appeared on behalf of Thomas. Hall said that Leifer was "evasive," and that his testimony was influenced by his opposition to electroshock and involuntary medical treatment altogether. The judge declared McDonough's testimony as "not helpful," saying it was based largely on a widely used intelligence test that measures cognitive ability and that he did not administer tests that measure psychosis or discuss Thomas' alleged illness or electroshock treatment.

The most damning testimony against Thomas, though, may have come from James D. Lynch, an independent psychiatrist who said Thomas has an acute form of bipolar disorder and manic behavior and needs more than the 40 shock treatments to help him function.

Briefs

April 25, 2001

Zachary R. Dowdy; Chau Lam

BRENTWOOD / Pilgrim Patient Wins a Stay Paul Henri Thomas, 49, the Pilgrim Psychiatric Center patient who is challenging the state facility's decision to give him electroshock treatments, will not have to undergo the procedure, at least for now, pending a decision from an appellate court.

On Monday, attorneys for Thomas secured from the Appellate Division a temporary stay of an order signed by State Supreme Court Justice W. Bromley Hall. Hall's order approved Pilgrim's request to administer 40 electroshock treatments.

The stay will remain in effect at least until Monday, the deadline by which Pilgrim officials must file papers with the Appellate Division, said Kim Darrow, an attorney for the state Mental Hygiene Legal Service, which represents Thomas.

After that, a four-judge panel will review the arguments from both sides and decide whether to grant another stay while the court reviews Thomas' appeal.

The stay, granted by Justice David S. Ritter, asks Pilgrim to make a case as to why shock treatments should not be prohibited while the court reviews Hall's order, which was signed April 20.

That order came after a weeks-long hearing in which Thomas challenged an application by Pilgrim in February to administer the 40 shock treatments. Hall ruled that the expert witnesses who testified for Thomas were not credible, saying in conclusion that the treatments are in Thomas' "best interest." Thomas, who Pilgrim doctors say displays signs of mental illnesses ranging from schizoaffective disorder to bipolar mania, has been in the Brentwood facility since May 1999.

He has received about 60 shocks in all, almost all of them against his will. Thomas signed papers consenting to the treatments in June 1999.

He underwent three procedures and then refused them. That's when doctors at Pilgrim sought court approval for the procedure, arguing that Thomas did not have the mental capacity to make medical decisions for himself. -Zachary R.

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(Shocked! ECT note: Tenet-owned hospitals are in red)

Source: Missouri Certificate of Need program; Bureau of Hospital Licensing; Missouri Department of Health

In St. Louis and St. Louis County, only 16 facilities provide beds for psychiatric patients. SouthPointe Hospital represents nearly 8 percent of the 1,354 beds available.

Hospitals, ranked by number of psychiatric beds:

1. St. Louis Psychiatric Rehabilitation Center, 5300 Arsenal Street, St. Louis, 215.

2. St. Anthony's Medical Center, 10010 Kennerly Road, south St. Louis County, 158.

3. Metropolitan St. Louis Psychiatric Center, 5351 Delmar Boulevard, St. Louis, 111.

4. Veterans Affairs Medical Center, 915 North Grand Boulevard, St. Louis, 117.

5. Barnes-Jewish Hospital, 216 South Kingshighway, St. Louis, 109.

6. SouthPointe Hospital, 2639 Miami Street, St. Louis, 104.

7. St. John's Mercy Medical Center, 615 South New Ballas Road, Creve Coeur, 82.

8. Christian Hospital Northwest, 1225 Graham Road, Florissant, 80.

9. DePaul Health Center, 12303 DePaul Drive, Bridgeton, 78.

10. Hawthorn Children's Psychiatric Hospital, 1901 Pennsylvania Avenue, north St. Louis County, 60.

11. Forest Park Hospital, 6150 Oakland Avenue, St. Louis, 59.

12. St. Louis University Hospital, 3635 Vista Avenue at Grand Boulevard, St. Louis, 47.

13. St. Mary's Health Center, 6420 Clayton Road, Richmond Heights, 44.

14. St. Alexius Hospital, 3933 South Broadway, St. Louis, 41.

15. Missouri Baptist Medical Center, 3015 North Ballas Road, Town and Country, 28.

16. Des Peres Hospital, 2345 Dougherty Ferry Road, Des Peres, 21.

Source: Missouri Certificate of Need program; Bureau of Hospital Licensing; Missouri Department of Health

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February 21, 2001
Riverview Hospital Report

Carried out by:

* Dr. Caroline Gosselin (Head, Dept. of Geriatric Psychiatry, VHHSC) - Chair
* Dr. Elisabeth Drance (Geriatric Psychiatrist, Providence Health Care) - Member
* Ms. Jeanette Eyre (RN and ECT Coordinator, UBC Hospital) - Member
* Dr. Norman Wale (Anesthesiologist, Dept. of Anesthesia, Royal Jubilee Hospital, Capital Health Region) - Member
* Dr. Athanasios Zis (Professor and Head, Dept. of Psychiatry, UBC and VHHSC) -Member
* Mr. Noam Butterfield (PhD candidate, Pharmacology & Therapeutics, UBC) - Secretary and Principle Facilitator
* Mr. Wayne Jones (MHECCU, St. Paul's Hospital) - Statistical Consult

February 21, 2001

Review of ECT Practice at Riverview Hospital February 21, 2001

PURPOSE: The Ministry of Health, Division of Mental Health Services, has appointed a committee to review the current practice of electroconvulsive therapy (ECT) at Riverview Hospital (RVH). The mandate of this review was to determine if patients at RVH are provided with ECT services that are appropriate and safe, and to make Recommendations to improve ECT service.

COMMITTEE COMPOSITION: * Dr. Caroline Gosselin (Head, Dept. of Geriatric Psychiatry, VHHSC) - Chair
* Dr. Elisabeth Drance (Geriatric Psychiatrist, Providence Health Care) - Member
* Ms. Jeanette Eyre (RN and ECT Coordinator, UBC Hospital) - Member
* Dr. Norman Wale (Anesthesiologist, Dept. of Anesthesia, Royal Jubilee Hospital, Capital Health Region) - Member
* Dr. Athanasios Zis (Professor and Head, Dept. of Psychiatry, UBC and VHHSC) - Member

ADDITIONAL CONTRIBUTORS: * Mr. Noam Butterfield (PhD candidate, Pharmacology & Therapeutics, UBC) - Secretary and Principle Facilitator * Mr. Wayne Jones (MHECCU, St. Paul's Hospital) - Statistical Consult

TERMS OF REFERENCE (as outlined by the Ministry of Health): Purpose: To determine if patients at RVH are provided with ECT (electroconvulsive therapy) services that are appropriate and safe, and to make recommendations to improve service.

Issue: ECT practice at RVH has been questioned by Dr. Jaime Paredes, Medical Staff President, in a letter to Honourable Corky Evans, Minister of Health and Minister Responsible for Seniors. Media coverage reflects concern for safety of clients.

Deliverables: The review will determine practices for both in- and outpatient ECT in the following areas and compare with accepted medical practice:

1. Equipment of Physical Design - specifications of the ECT machine (e.g. waves, voltage, monitoring heart rate, e.e.g.s etc) design of the ECT and recovery rooms, safety and anesthetic and ancillary equipment issues.

2. ECT Technique and Anesthesia - issues of technical competence (unilateral versus bilateral; timing of current, wave forms, etc) that are designed to have the therapeutic effect and reduce memory disturbance. Medications including type and dosage of anesthetics used during ECT and physiological monitoring during ECT.

3. Care Plan and Documentation - protocols and guidelines in place for ECT. Clear documentation of Assessment and treatment plan.

4. Preparation and Aftercare - preparation of the patient for the procedure and aftercare including instructions to caregivers.

5. Patient Selection - exclusions for other medical conditions, characteristics of psychiatric conditions including non-responsiveness, urgency, etc. and indications for second opinions and other consultations are addressed. Indications for maintenance ECT.

6. Patient Education/Consent - process for informed consent; consent forms; completed methods of presenting material to patients and families.

7. Staff Training - level of skill and knowledge of staff involved in any aspect of providing ECT.

8. Monitoring and Evaluation - RVH practice of monitoring important aspects of ECT. Trends and comparisons in the use of inpatient and outpatient and maintenance ECT. Monitoring, on a periodic basis the type of equipment, techniques, staff training and patient outcomes.

NOTE: The review is to address system issues as opposed to professional practice of individuals. Individual practice concerns are not the purview of this report and, therefore the review team will refer such issues to appropriate RVH professional bodies and/or provincial practice bodies.

REVIEW PROCESS: Discussions were held over three days with management, medical staff, nursing staff, patients and their families and patient advocacy groups.

---

The first site visit was conducted on January 16, 2001, during which the review team members, the terms of reference and the review process were introduced to President/CEO of RVH, Chair of the Board of Trustees, the Clinical Executive Team and ECT staff representatives. Following introductions, meetings were held separately with the following groups:

* ECT physicians (psychiatrists and anesthesiologists) and ECT Nursing Staff
* Coordinator of the ECT program and Manager of the ECT Program
* Vice President, Medicine and Research and Vice President of Clinical Services
* President, Medical Staff Association
* Medical Director and Patients Services Director of the Geriatric
Psychiatry Program and five Medical Staff
* Medical Director and Patient Services Director of the Adult Residential Transfer Program
* Medical Director and Patient Services Director of the Adult tertiary Redevelopment Program
* An open forum was also held for any other Riverview Hospital Staff, patients, families or advocacy groups, to voice any concerns and provide feedback.

During the second site visit on January 17, 2001, time was spent observing patients in the pre-ECT room, in the treatment room, and in the post-anesthetic recovery room, as well as being transferred back to the ward. A discussion was held with families of some of the patients who received ECT treatment this day. A chart review was initiated and additional discussions were held with the following:

* Union of Psychiatric Nurses (UPN, Local 102) Nurse, Aggressive Stabilization Ward and Vice President, UPN
* Five members of Medical Staff Organisation

On January 22, 2001, discussions were held with the following:

* Ten Geriatric physicians * Vice President of Clinical Services

In addition to the three site visits, materials provided by Riverview Medical Staff and Administration were reviewed. Substantial correspondence received by the Minister from a variety of individuals and organisations was forwarded to the team as well.

ASSESSMENT AND RECOMMENDATIONS:

1. Equipment and Physical Design

Assessments: PHYSICAL DESIGN Riverview Hospital houses a newly built ECT suite on the ground floor of Valleyview Pavilion with formal operation underway since December, 2000. This current location was found to be well located with respect to the patient population served. It encompasses a waiting area for patients and families, a treatment room and a recovery room capable of managing 4 post-ECT patients. It is clean, spacious, well lit, and provides a comfortable environment for both recipient and providers of ECT.

ECT EQUIPMENT The ECT suite is equipped with the newest ECT devices available. A Spectrum 5000Q is used for daily ECT. A Thymatron and an older model of MECTA (the JRI) are also in the treatment room for backup in the event of equipment failure.

ANESTHESIA EQUIPMENT a) Stretchers - The stretchers are of current design, safe and sturdy. b) Monitoring Equipment - Blood pressure, heart rate, electrocardiogram, haemoglobin saturation and neuromuscular transmission monitors are all of current design and good quality. c) Suction Equipment - Suction availability, although not through a central system, is adequate. Three such suctioning units were tested and all well functioning.

2. ECT Technique and Anesthesia

ECT TECHNIQUE Assessment: ECT Technique was uniformly praised by all those interviewed, including by those who raised concerns in other domains.

Patients are prepared for ECT in accordance with APA standards i.e.: skin cleansing with alcohol, application of abrasive and non-abrasive conductant gels. Bilateral lead placement is routinely used with the Titration Method dosing strategy according to the protocol devised by Duke University. A standard rubber mouth guard is inserted into the patient's mouth prior to ECT and the anesthesiologist provides jaw support during the delivery of the stimulus itself. The ECT device creates an EEG recording of the convulsion, which is documented on a flow sheet.

It is presumed, given the training the treating psychiatrists have, that EEG morphology is used as an adjunct to the progress report of the patient's physician to determine electrical dosage used for each treatment. We observed the Coordinator of ECT Services deliver ECT for several patients. The remaining five psychiatrists who deliver ECT declined to allow us to observe them - stating that we did not have the authority to do so. They cited receiving advice from the College of Physicians and Surgeons of B.C for their decision. The Coordinator of ECT Services informed us that they have all received ECT training at either Canadian or American programs and practice accordingly.

Recommendation: Although the choice of electrode placement is a subject of continuous research and discussion, recent evidence suggests that the therapeutic outcome of unilateral electrode placement of sufficient electrical intensity is comparable to bilateral ECT, but with reduced cognitive side effects. The choice of electrode placement should be reviewed and updated.

ANESTHESIA Assessment: Oxygen Supply: The provision of oxygen was adequate, although the addition of a pressure gauge to provide "real time" monitoring of supply/pressure would be desirable. Absent also was any conspicuous visual or auditory alarm to be deployed if there should occur a failure in oxygen supply. A large K-cylinder of oxygen as back up supply was readily at hand.

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Drug Supply: Sufficient and appropriate drugs are readily available. Drugs and equipment required for resuscitation are also appropriately stored, labelled, and immediately available. Surveillance and replenishment of dated drugs is an ongoing commitment of Riverview Pharmacy.

Practice: The current practice in the provision of anesthesia for ECT at Riverview Hospital conforms to the "Guidelines to the Practice of Anesthesia, revised edition 2000" as recommended by the Canadian Anesthesiologists' Society. The safe and courteous conduct of anesthesia was apparent, as was the cooperative compassionate approach to patient care.

Recommendations: a) "Real time" monitoring of oxygen supply pressure should be provided. b) Auditory and visual alarms to notify personnel of failure of oxygen supply are also recommended. c) Consideration should be given to the use of "needle-less" supplies for the administration of drugs and/or intravenous fluids. There is no doubt that patients receiving therapy later in the day do benefit from intravenous fluid administration, and such fluids may be given utilizing one of the several "needle-less" products which are currently available. The principle advantage of using "needle-less" supplies continues to be the reduced risk of "needle-poke" injuries.

3. Care Plan and Documentation

Assessment: We reviewed the following documents and guidelines:
* ECT Consent Process (Flow sheet)
* Consent for ECT Treatment (Guidelines)
* Consent for Treatment, Involuntary Patient
* Consent for Treatment, Informal Patient and Outpatient
* ECT - Information for Patients and Families (1997)
* Preparing for ECT - Information for Inpatients (1997)
* Preparing for ECT - Information for Outpatients (1997)
* ECT Information For Students (1996)
* Pre-ECT Nursing Checklist
* ECT Ward Nursing Guidelines
* Request for Consultation (form)
* ECT Service Procedure Manual: Pre-ECT/Pre-Anaesthesia Consultations
* Pre-ECT Medical Checklist
* Medications Used In ECT - A Brief Compendium for Ward Nursing Staff
* ECT Service Procedure Manual: Duties of the Escort Nurse
* ECT Service Procedure Manual: Duties of the Waiting Room Nurse
* ECT Service Procedure Manual: Description of the ECT Treatment Process
* ECT Service Procedure Manual: Clinical Nursing Procedures in the ECT Room
* ECT Service Procedure Manual: Description of the ECT Treatment Process
* Medical Staff Policy & Procedure Manual: ECT (1997)
* ECT Service Procedure Manual: Anaesthesia Procedures in the ECT Treatment Room
* ECT Treatment Room Drug List (1996)
* Communication In the ECT Suite
* ECT Treatment Record
* ECT Nursing Record
* Methicillin Resistant Staphylococcus Aureus Guidelines (MRSA) (1997)
* Management of Patients Infected or Colonized with MRSA and other Multiple Drug-Resistant (MRO) Microorganisms
* ECT Service Procedure Manual: PARR Equipment
* ECT Service Procedure Manual: PAR Nurse Qualifications
* ECT Service Procedure Manual: Clinical Nursing Procedures in the PARR
* ECT Service Procedure Manual: Documentation In the PARR
* ECT Service Procedure Manual: Nurse to Patient Ratio in the PARR
* ECT Service Procedure Manual: Post Anaesthesia Recovery Room
* ECT Service Procedure Manual: Medical Emergency - Code Blue
* ECT Service Procedure Manual: Criteria For Discharging Patients from the PARR
* ECT Outcome Evaluation

Recommendations:
These guidelines are comprehensive and clear and only minor changes are recommended:
a) Aortic Stenosis is not listed in the "Medical Staff Policy and Procedure Manual (1997)" as a relative contraindication
b) The document "CLI-005 Description of the ECT Treatment Process" contains inaccurate information and is poorly written. It needs to be revised and the author and purpose of such a document identified.

4. Preparation and Aftercare

Assessment: Preparation of the patient begins as soon as a decision has been made that ECT is a recommended treatment choice for the patient. The attending physician discusses treatment options with the patient including the possibility of ECT. An "Information for Patients and Families" booklet on ECT is given to the patient and family members if possible, prior to being asked to sign consent for ECT. The patient and family members both have the opportunity to meet with the attending physician to ask questions about the recommended ECT. If the patient is capable of giving informed consent the attending physician will meet with the patient and review and explain the information on the back of the ECT form.

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Patients and families are also encouraged to view a video about ECT as well as visit the ECT suite prior to beginning ECT to meet the Staff, see the facilities and address any concerns they may have about the process.

A pre-ECT nursing checklist is completed prior to the patient leaving the ward (for inpatients) and checked by the waiting room nurse. For outpatients, the waiting room nurse completes the pre-ECT nursing checklist.

The PARR nurses manage the patient's airway, administer oxygen at 6-8L per minute, and monitor the heart rhythm by ECG. They also assess and score the following every five minutes until the patient meets discharge criteria: blood pressure, pulse, respiratory rate, oxygen saturation, level of consciousness and muscle strength. When the patient has met the criteria for discharge from the PARR they are transferred from the stretcher to a wheel chair and returned to the waiting room. The waiting room nurse receives a verbal report from the recovery room nurse of any significant information. This is in turn passed on to the escort nurse or to the person returning the patient to a facility or home. The patient is offered cookies and juice in the waiting room prior to discharge from the ECT suite. Patients returning to their wards will have their vitals assessed and recorded within 30 minutes.

Outpatients are discharged home in the care of a responsible adult.

Concern was raised about the length of time some patients were required to fast prior to receiving their treatment, despite requesting an earlier time slot. The ECT Treatment Team are aware of this and have responded by suggesting methods of keeping patients hydrated (e.g. with intravenous fluids) prior to their treatment. They have also attempted to accommodate these patients as best as possible.

Recommendations: a) Improved communication is necessary to facilitate the issue surrounding fasting patients (i.e. personal contact rather than an answering machine). Without increased resources such as a registered nurse (on site five days per week), this will be difficult to accomplish. b) Riverview needs to expand their discharge information for outpatients and identify staff responsible for providing this information. A checklist would ensure this information has been disseminated (as is already established for inpatients).

5. Patient Selection

PATIENT SELECTION Assessment: There was a lack of pertinent statistics pertaining to ECT at Riverview. Moreover, due to time constraints it was not possible to conduct a systematic chart review to address issues pertaining to patient selection. There is however, no doubt that the number of ECT procedures at Riverview has increased over the last few years and that this increase in ECT procedures is primarily due to an increase in ECT procedures for geriatric patients. There is insufficient information available to draw any firm conclusions regarding the rate of ECT across age and diagnostic groups or the number of treatments per patient. For the same reason, it is not possible to draw any conclusions whether patient selection and utilization are in agreement or at variance with other provincial, national and international data.

Efforts are being made by an internal subcommittee at Riverview to address questions related to appropriate utilization of ECT, and we were pleased to be informed of changes of the composition of said committee to better accommodate the concerns of the Medical Staff for a more objective assessment.

Recommendation: The committee, due to inadequate data, is unable to draw any conclusions regarding ECT patient selection and utilization at Riverview. The committee strongly supports the internal review currently underway under the auspices of the Riverview Medical advisory Committee and cannot underscore enough the need for an independent and objective review process. Although this Review Team cannot speak to Riverview's numbers, nor the appropriateness of patient selection, the Ministry of Health and Ministry Responsible for Seniors needs to extend effort to refine ECT data collection and examine ECT use Province-wide.

SECOND OPINION FOR TREATMENT Assessment: Several staff aired concerns about the process of a second psychiatric opinion. It was pointed out that the bulk of the ECT at Riverview is carried out by Geriatric Psychiatrists for Geriatric patients.

Recommendation: We recommend that second opinions should be done in a more objective manner i.e.: by Adult psychiatrists for geriatric patients. The Geriatric Psychiatrists have agreed with this in principle and have added that it is also crucial for the second opinion to be done by psychiatrist well versed in ECT. They have expressed a desire for Adult Psychiatrists to join the ECT delivery team in the future.

6. Patient Education / Consent

PATIENT EDUCATION Assessment: Patients and families are invited to view a video regarding ECT and are provided with written brochures (appended). They are further referred to Riverview's library for additional information. Attending physicians also spend time preparing patients and their families for ECT. Despite this, at the open forum, some patients, as well as the Patient Advocacy group representative, expressed a concern that often, patients do not fully understand ECT and are scared during their initial treatment.

The family representatives that spoke at the open forum, as well as those interviewed on the second review day, all expressed a sense that they had been given ample relevant information prior to the treatments. They also felt strongly that their input had been valued in the initial decision to proceed with treatment.

Recommendation: While fear of medical procedures and or anesthesia is common, Riverview Staff need to remain sensitive to patients' reactions during a course of ECT and encourage education and support. CONSENT Assessment: We did not witness any consent interviews during our visit. Therefore, our data comes from chart review and discussion with the above-mentioned parties.

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The process being followed for informed consent is well outlined in documents appended here. In addition, the Coordinator of ECT Services stated that ECT was not given without the consent of family, even though that may not formally be required under the Mental Health Act.

In charts reviewed by the team, appropriate consent documents were found in 100% of cases.

The facility has a clear understanding of the effect of the new Guardianship Legislation on consent and has built in new steps to accommodate this.

Involuntary patients may sign consent forms for themselves if their physician considers them to be mentally capable; however, if they are incapable of signing, the Vice President of Medical and Academic Affairs must sign as "Deemed Consent".

Although this consent process is outlined in the ECT Policies and Procedure Manual on all wards, some staff indicated that they are unaware of the VP's decision-making "checklist" in signing "Deemed Consent" for Involuntary patients.

Recommendation: The VP of Medical and Academic Affairs' role in consent for Involuntary patients should be clearly delineated and communicated to staff.

NUMBER OF TREATMENTS IN CONSENT Assessment: Some concern was expressed by a number of physicians that the consent form, being designed for up to fifteen treatments, might influence the number of treatments given. Certain physicians recommended reducing the number of treatments in a course per consent.

Recommendation: The average number of treatments for an index course is normally between six and twelve, however more may be needed. It is advisable that a new informed consent form is signed after a course of twelve treatments or a period of six months.

7. Staff Training

PHYSICIANS Assessment: Since the last review in 1996, the prerequisite training for psychiatrists wishing to carry out ECT has increased significantly. Attendance at the Duke University Course in ECT is recommended, and most of the psychiatrists currently performing ECT have attended this course. All of them endorse it as an outstanding experience which has prepared them well to carry out ECT. Currently, the hospital pays for missed sessional time while the individual pays for their airfare, accommodation, and course registration.

Some psychiatrists have expressed concern that the hospital should fully compensate physicians for attending this course if it is a prerequisite to practising ECT. According to the Coordinator of ECT Services, while the course is strongly recommended, equivalent experiences can be arranged within British Columbia for those who do not wish to attend. The Coordinator of ECT Services is insistent that psychiatrists practising ECT require sophisticated skills, as the patient population at RVH frequently suffers from co-morbid medical conditions.

Consideration is being given to having a separate credentialing process for psychiatrists wishing to practise ECT in order to maintain high standards of practice.

Currently, exposure to the ECT suite and the practice of ECT is not part of the orientation for Physicians.

Ongoing ECT grand rounds are offered annually. However, in our discussions with physicians and nursing staff, questions were raised about the increasing numbers of geriatric patients with dementia who were receiving ECT. There seemed to be limited understanding of the current changing indications for ECT in people with Dementia. Recommendations: a) The criteria for joining the ECT treatment team, as a Psychiatrist, need to be clarified (i.e. what constitutes an adequate "specific training course/lecture" as specified in the Medical Staff Policy and Procedure Manual, 1997). b) All physicians hired at Riverview Hospital should receive an orientation to the ECT suite and the practice of ECT. This should become a formal part of their orientation to aid in their understanding and decision-making about ECT. c) ECT Grand Rounds should continue to occur on an annual basis and should reflect the educational needs voiced by staff. This would be an excellent opportunity to relay new research findings related to ECT.

NURSING Assessment: In-services about ECT have been held and ECT information and procedure binders have been created for each ward. There appears however, to be a lack of ongoing education for Riverview nurses. This concern was voiced by The Coordinator of ECT Services and the nurses from the ECT Treatment Suite. In particular, staff who are rarely involved with patients undergoing ECT should nevertheless be kept abreast of ECT practices at RVH. Recommendation: All nurses at RVH should be required to spend time in the ECT suite to develop thorough knowledge of the indications for and the practice of ECT. In additions, they should be oriented to the current indications for ECT to enhance their ability to participate in team ECT decisions.

8. Monitoring and Evaluation Assessments: a) The ECT program lacks a detailed database. Statistics currently kept are collected manually by staff in the ECT suite. This deficit makes examination of the RV practice of ECT with respect to patient selection and outcome virtually impossible.

We have been made aware by the administration at RVH that a database is not likely forthcoming for at least another year and a half. This hampers both monitoring of clinical practice and research initiatives.

b) While an outcome tool was included in our pre-reading package, it was not found on any of the charts reviewed.

d) Similarly to the Inpatient population, there is little data regarding the use of outpatient ECT at Riverview. Monitoring of the progress of these patients occurs partially in the community, and partially by ECT physicians. There are no dedicated resources for Outpatient ECT.

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Recommendations: a) The ECT program at RV is in need of a database in order to gather statistics that will answer the questions regarding utilization of the practice of ECT. A year and a half delay is unacceptable and needs to be reassessed. b) An appropriate ECT outcome tool needs to be completed for each patient at the completion of the Index Course of ECT and then on an ongoing basis for those patients receiving Maintenance ECT. It should be included and easily identified in the patient chart.

c) Riverview needs to enhance and formalise an outpatient ECT clinic. This would involve an expansion of resources. A full-time ECT nurse coordinator could take on several roles including: i. Enhancing ECT education to patients, families and staff (e.g. managing groups) ii. Participating in planning for further education iii. Liasing with the community referral source for patient management iv. Maintaining outpatient ECT statistics.

Additional resources would also allow for additional ECT days (Tuesday and Thursday). This would reduce the total number of patients treated in one day and therefore reduce the waiting time for patients requiring who must fast prior to treatment.

Additional observations: While Riverview is filled with talented and caring professionals, it appears to struggle in the area of developing a healthy work culture.

In our review, we met with a wide variety of professionals including psychiatrists, nurses, anesthesiologists, general practitioners and administrators. Many described their interdisciplinary relationships with colleagues and other health care providers as thoroughly satisfactory. Others expressed fear that speaking out about controversial subjects leads to retribution by the administration in the form of termination of contracts or demotions.

These are serious allegations. They point to a culture which feels unwelcome of diverse opinions, which threatens people's sense of security, and which is strongly hierarchical. The involvement of the media and letters to the health minister may be reflections of this culture.

Riverview Hospital needs to foster an improved quality of internal communication and provide manifestation of respect for individuals' freedom of expression.

Concluding Remarks:

ECT delivery at Riverview Hospital is of high quality. Protocols and guidelines for safe and effective application are in effect. A Reasonable and acceptable informed consent process is in place which is in keeping with current legislation. There are some areas for improvement such as revising second opinion protocols, updating education for Riverview Staff, and expanding resources for outpatient ECT.

Although questions have arisen pertaining to ECT utilization, the lack of trust that such issues will be fairly addressed within the organization has caused this issue to become public. The staff, patients, and families of Riverview Hospital have experienced distress as a result of adverse publicity. There is a need for Riverview Hospital and other health care professionals to improve public understanding about ECT.

The number of ECTs at Riverview Hospital has increased. Data explaining this increase are currently unavailable and therefore conclusions regarding utilisation cannot be made at this time. A comprehensive Province-wide database, including appropriate outcome measures, is essential.

February 21, 2001 Riverview Report

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Many women suffer with both major depression and anxiety. Here's why and the difficulties that come with treating comorbid anxiety and depression in women.

1. Major depression in women is twice as common as in men - lifetime prevalence 21% for women. At age 10, the incidence difference begins to differ between the sexes, and peaks by mid to late adolescent.
2. Women are more likely to have an increase in stressors prior to the depression diagnosis than men. Anxiety, panic, somatic complaints, increased appetite, weight gain, guilt, and decreased sexual desire are more apt to be seen in women that men. Comorbid psychiatric disorders are more common. Women attempt suicide more often than men but men are more apt to be successful with the attempt.
3. Why is depression more common in women than men? May be due to genetic transmission or difference in brain structure. Depression is also associated with reproductive function. There are many psychosocial risk factors. Lack of work outside the home may be a risk factor, along with marital conflict (women three times more apt to be depressed in an unhealthy marriage than men) and the presence of young children in the home.
4. Depression and anxiety together usually results in more treatment difficulties - often with the need for higher med dosing with longer duration of med use.
5. Women with anxiety have much more panic and phobia problems than men. Posttraumatic stress disorder in women is more common along with a history of sexual abuse in women with PTSD.
6. Tricyclic antidepressants can have significant side effects once at therapeutic doses to treat depression. The lethal potential is greater than with the SSRI's as well.
7. Panic disorder in women is associated with a more frequent relapse when the meds are discontinued. SSRI's are effective as this is most thought to be due to a serotonin deficiency. Starting at low dose and then titrating up to the mid or higher end of the dosing schedule for any given ssri is the recommended way to go. Beginning a benzodiazepine with the SSRI initially can be acceptable, but it is important to let the patient know that this is a temporary medication.
8. Cognitive therapy is a valuable adjunct to medication use and should not be forgotten.
9. Premenstrual dysphoric disorder (PMDD) - premenstrual and cyclical with mood symptoms (irritability is the hallmark), along with other typical depressive symptoms. Women with postpartum depression, history of mood changes when on bcp's have a higher incidence of PMDD. The theory of this is that there is a decrease in serotonin function. There is also serotonergic dysregulation.
10. Treatment of PMDD - one a day multivitamin plus calcium, diet modification with smaller and more frequent meals with higher carbohydrates and less fat, nsaids can be effective for the dysmenorrhea, and consideration for SSRI medications. The SSRI's work "immediately" to treat the PMDD as they effect serotonin levels immediately. Some may already be on an SSRI and can "bump up" the dose for the one to two weeks of PMDD symptoms. The low dose of an SSRI may be all that is needed to treat the PMDD especially if there is no other comorbid condition such as anxiety or depression
11. Postpartum depression (PPD) can also be well treated with SSRI's. Treatment for a minimum of one year is suggested. There can be an increase in conduct disorders and depression in children of women with untreated postpartum depression. Women with a previous history of PPD do better when given meds prophylactically shortly after the birth or even before birth (ssri's are category C, however -so one must weigh the risks and benefits) if the mother has a history of the depression beginning before the child is born. Minimal case reports of problems noted in babies breastfeeding whose mothers are on an SSRI medications.
12. Depression during the perimenopause: commonly seen together. Early menopause is risk factor, as is surgical menopause.

The Concise Guide to Women's Mental Health is a book that can be obtained from the American Psychiatric Association to get additional advise in medication prescribing in breastfeeding or pregnant women.

Source: Annette Smick, M.D. (Marquette General Hospital), Feb. 2001

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Anxiety and work is a little discussed topic. Stress, yes. But not anxiety. Yet work has much anxiety associated with it. Our success or failure rests on our ability to deal with the unknown. Doubts about our individual competence run through us all. Some of the tasks we have to perform may be unpleasant, distressing, or irritating.

In the last fifty years, a growing field of inquiry has focused on how these anxieties get handled in organizations. A seminal study was produced by Isabel Menzies Lyth (1959) on a consulting project she did with an English teaching hospital. The presenting problem was the concern voiced by senior staff that student nurses' training was driven more by work demands of the hospital than the training needs of nurses. What she discovered was an extremely high level of distress and anxiety within the nursing staff - so high in fact that about one third of student nurses left each year of their own volition.

Her initial observation was that the work of nursing is itself exceptionally anxiety-producing. Nurses work with people who are ill or dying. Wrong decisions can have devastating consequences. Nurses must respond to the distressed family of the patient. Many tasks are distasteful or repulsive.

She also observed that the way work was organized seemed directed at containing and modifying this anxiety. For instance, there was a dominant belief that if the relationship between nurse and patient were close, the nurse would experience more distress when the patient was discharged or died. Work practices encouraged distance. Nurses were required to perform a few specialized tasks with a large number of people, thereby restricting contact with any one patient. Calling patients by their condition - "the liver in bed 14"- rather than their proper name was common. Similarly, the weight of responsibility for making a final decision was mitigated in a number of ways. Even inconsequential decisions were checked and rechecked. Tasks were "delegated" up the hierarchy, with the result that many nurses were doing work well below their competence and position. In some cases subordinates were reticent to make decisions; in others guidelines were not in place to implement delegation.

These procedures appeared analogous to individual defense mechanisms. While they protected the nurses from their original anxieties, they created new ones. For instance, nurses and student nurses in particular, were given lists of simple tasks over which they had little discretion on how to perform them. Consequently they would wake patients to give them sleeping pills! They woke patients early in the morning to wash their faces before the doctors arrived, despite feeling that they would be better off sleeping. In interviews, nurses expressed guilt that they had in fact practiced bad nursing even though they carried out procedures to the letter. They knew they were not caring for patients' needs, but the system's needs.

Menzies Lyth argued that substantial parts of the hospital organization constituted social defenses (Jaques, 1955) that helped individuals avoid anxiety. The nursing management made no direct attempt to address the issue of the anxiety-provoking experiences and develop nurses' capacity to respond to anxiety in a psychologically healthy way. They did not, for instance, acknowledge that a patient's death affected nurses or provide support to deal with this and other distress. Instead, the rationale developed that a "good nurse" was "detached".

Menzies Lyth proposes that an organization is influenced by four main factors: (1) its primary task, including related environmental pressures and relationships. (2) the technologies needed to perform the task, (3) the need of members for social and psychological satisfaction, and (4) the need for support in dealing with anxiety. She argues that the influence of task and technology is often exaggerated, and that the power of psychological needs of members is generally underestimated as an influencing force. Task and technology are the framework- the limiting factors. Within those limits, the culture, structure, and mode of functioning are determined by psychological needs.

If support for anxiety is not provided, people will still find ways to insure that their anxieties are eased. The process will, however, be unconscious and covert, and the defenses developed against anxiety will become embedded in the organization's structure and culture. As we saw with the nurses, these defenses may work counter to the needs of the primary task. They may not make sense. But they are an aspect of the organization's reality to which everyone must adapt or leave.

So if we look at any organization's processes and culture, do they make more sense from a rational productivity perspective, or can they be better explained as social defenses? What about governmental bureaucratic procedures? What about the current culture of heavy work loads and long hours? As with the nursing practices, both are well in place with many people complaining about them.

The striking point arising from Menzies Lyth's study is how deeply vested we all are in the way things are done. Those of us who work to introduce change into organizations must be sensitive to how dependent we all are on social defenses. We must recognize the active function that many dysfunctional processes fulfill in the psychological lives of members if we are to keep ourselves grounded in the reality of how difficult change is to achieve.

References

Menzies Lyth, Isabel. "The Functioning of Social Systems as a Defence against Anxiety", in Containing Anxiety in Institutions, Free Associations, London, 1988. pp 43-85.

Jaques, "Social Systems as a Defense against Persecutory and Depressive Anxiety", in New Directions in Psychoanalysis, Klein, Heimann, and Money-Kyrle, Eds., Tavistock Publications, London, 1955. pp 478-498.

© 2001 All rights reserved. The authors are Brian Nichol and Lou Raye Nichol or call (919)303-5848.

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