September 15, 2008

NIH Study: New Antipsychotics More Risky For Kids Than Old Antipsychotics

Results of the long-awaited TEOSS trial, sponsored by NIMH, were released today by the American Journal of Psychiatry. The study randomly assigned 119 children and teens aged 8 to 19 diagnosed with psychotic symptoms to receive either Zyprexa or Risperdal--two new generation antipsychotics--or molindone, an old antipsychotic, in an 8-week study. The results were very bad for the newer drugs and, in fact, were so bad for Zyprexa that a government oversight panel ordered that kids taking Zyprexa be taken off the drug due to explosive weight gain, an average of 13 pounds in 8 weeks. (Where have we heard that story before with Zyprexa?)

These results (pdf here) need to be understood not only in the context of psychotic symptoms but in the context of these new drugs' use in children and teens being treated for autism (Risperdal is FDA approved there), pediatric bipolar disorder (the FDA has approved Risperdal and Abilify there) and ADHD (no FDA approval for the drugs there) where these drugs are commonly used off-label. Risperdal is approved for use in schizophrenia in adolescents, but not in children. Zyprexa's schizophrenia approval is for adults only.

In my opinion, the TEOSS study results are the death knell for the common and far too casual use of these drugs in kids. Not that the picture is any more pretty in adults.

So what did the study show?

"No significant differences were found among treatment groups in response rates (molindone: 50%; olanzapine: 34%; risperidone: 46%) or magnitude of symptom reduction. Olanzapine [Zyprexa] and risperidone [Risperdal] were associated with significantly greater weight gain. Olanzapine showed the greatest risk of weight gain and significant increases in fasting cholesterol, low density lipoprotein, insulin, and liver transaminase levels. Molindone led to more self-reports of akathisia."

Conversely, that means that large numbers of kids receiving each drug either saw no response or stopped taking the drug due to problems with its use: 50 percent in molidone, 66 percent in Zyprexa and 54 percent in Risperdal.

These results are not wildly different--in fact, they are worse--from what was seen in the 2005 CATIE study of the new antipsychotics used in treating schizophrenia in adults.

What did researchers tell the press?

From the New York Times:

"Dr. Jon McClellan of the University of Washington, a co-author of the new study and of the current guidelines for treating childhood schizophrenia, said in a telephone interview that older schizophrenia drugs should now be considered as an alternative in some cases.

"'Some of the children in this study gained 15 pounds or more in eight weeks,' Dr. McClellan said. 'That’s as much as adults gain in a year on these medications. Children are especially susceptible to these side effects, and this has broad implications across the board, for the use of these agents to treat any disorder.'...

"'I think the reason the use of these newer drugs has gone up so fast is that there was this widespread assumption that they were safer and more effective than what we had before,' Dr. McClellan said. 'Well, we’re seeing now that that’s not the whole story.'

Approximately 2 million children--and maybe more--are being given these drugs for various disorders. It's time to reconsider their use.

Moreover, I'm not sure how much an advantage would be gained by using older drugs such as molindone, as the 8-week trial was too short to capture the various side effects that crop up later with use of first-generation antipsychotics such as Parkinsonism, aka zombieism.

I suspect I'll have more on this study soon.

Posted by Philip Dawdy at September 15, 2008 09:48 AM
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Comments

"Childhood schizophrenia"? I admit to being a bit behind the eightball on this but I thought schizophrenia didn't usually present until age 20 at the earliest. But this article is talking about it in 8 year olds as if it's the most normal thing in the world for an 8 year old to have schizophrenia. Are you telling me this is another disorder that's being pushed into the pre-teens and "treated" with all those dreadful drugs? It's all just too much for me to take in right now. All I want to say is "Say NO to antipsychotics!" Especially in kids!

Posted by: Sara at September 15, 2008 12:04 PM

Gosh, do you really need to be a rocket scientist--or do a big, fancy study--to figure out that a 13-15 pound weight gain in 8 weeks on someone (presumably--these are kids, after all) under 100 pounds is unacceptable???

Posted by: Sherry at September 15, 2008 12:48 PM

Lilly Zyprexa ' Chemical Straitjacket' Use by Children.

Zyprexa,as well as the other atypical antipsychotics, are being prescribed for children, even though this is an unapproved, off-label use. Eli Lilly has been charged in allegedly pushing the drug for children in more than one state.

A report by Dr. Cooper at Vanderbilt University states that 2.5 million children are now taking atypical antipsychotics.

St. Petersburg Times Reports on Zyprexa A risky drug may get wider marketThe FDA may approve Zyprexa for kids, despite its significant side effects in adult use.

http://www.youtube.com/watch?v=uuK1t474ei4
(must see clip)

Daniel Haszard Zyprexa patient who got diabetes from it.

Posted by: Daniel Haszard at September 15, 2008 01:42 PM

I got the schizophrenia. I don't take any medicines for it. Why do these children have to?

Posted by: mark p.s.2 at September 15, 2008 04:46 PM

Mark,
Alas, they have no choice. Children are chattel in our society.

Posted by: Sherry at September 15, 2008 05:34 PM

I recall learning "hebephrenic schizophrenic" back when I was taking Abnormal Psych.....I think that category has bit the dust though...that wouldn't be a child schizophrenic, but an adolescent.

Posted by: susan at September 15, 2008 06:13 PM

Re:Sherry
"they have no choice"
Yes I know.
I was just trying to point out the diagnosis is an afterthough, a justification to drug the minds of misbehaving children. Psychiatry makes this invisible discipline possible in the clean name of science. A better world through chemistry.

Posted by: mark p.s.2 at September 16, 2008 04:34 AM

No they should not be used for children, or for most adults for that matter, given the death and disability rates. However, the biggest users are Medicaid and the question is how to police Medicaid. Is there a way the semi-moribund federal Medicaid and Medicare guys could be awakened from their slumber? Doubtful. It is up to the states, and to people who are willing to help the states police the use of this lethal stuff. For children AND for adults. Think of all the adults with mental illness who are now living their lives with diabetes in addition to their mental condition. I have heard of a few very good ideas to help doctors and state medicaids do a better job. Save money. Save lives. Beat back Pharma.

Posted by: Sorrowful at September 16, 2008 12:36 PM

Life is hard enough as an adult mental patient; shrinks regularly abuse their authority to mind f*ck patients into taking drugs that they (presumably) know have lots of side effects...all while claiming the meds are "safe and effective." God only knows how they deal with kids who have no rights and are often in pdoc's offices because their parents are frustrated and/or incompetent.

On the other hand, I'm glad to see more studies using better old-school antipsychotics to compare to the atypicals. Back when the atypicals first rolled out, the studies were using like 20mgs of Haldol versus the atypicals (at moderate doses): of course, the atypicals looked *awesome*.

Molindone sucks (antipsychotics generally do), but its kind of atypical-ish, has antidepressant qualities, and can cause weight loss...I think its a better drug to use to compare to zyprexa than, say, Haldol..it (Moban) is also less toxic than the phenothiazines, so this is an even better comparison than the perphenazine (Trilfaon) vs. the atypicals done in the CATIE study.

Posted by: Off_meds at September 16, 2008 01:18 PM

I've have had plenty of experience with the older antipsychotics and the atypicals. They're all ghastly drugs. I only take Seroquel now for a sleep aid.

Like the poster above, I was surprised to read about "childhood schizophrenia." The first psychotic break is usually in the early 20s. I've been diagnosed with schizophrenia and miraculously recovered. Hope these kids do too. I think the ticket is to recover from the psychiatric religion. It's like becoming an ex-Jehovah's Witnesses. Difficult but certainly worthwhile.

Posted by: Francesca Allan at September 17, 2008 08:25 PM

I am the father of an 8 yr old boy who is taking Risperdal. I have read many articles regarding the use of atypical antipsychotics in children and am very concerned about my son’s health and safety. My son does not have severe or even moderate mental health problems. He has not been diagnosed bipolar, autistic or schizophrenic. Nothing like that at all. The Doctor who sees him now has labeled him ADHD. However, a ten day evaluation at the Salem Hospital Pediatric Day Treatment Facility revealed that he suffered from depression. They did not diagnose him ADHD. My former wife began taking my son to mental health professionals because of anger outbursts and disruptive behavior. My son is a normal healthy boy. I disagree with the off label use of risperdal in my sons case. I would very much like to establish dialogue with other Mothers, Fathers, Grandmothers, etc who have experience with or have first hand knowledge how harmful atypical antipsychotics can be. I am particularly interested in cases involving children.
I can be reached at pkrlra@msn.com

Posted by: Peter Nelson at October 7, 2008 11:10 PM

Peter,
I trust you're in regular dialogue with an excellent attorney also.
Best wishes,
Sherry

Posted by: Sherry at October 8, 2008 04:48 AM

Yes I am Sherry. Thanks for the well wishes

Posted by: Peter at October 8, 2008 06:27 PM

My son who is age 30 now, started taking Risperdal
and Valproic Acid about three years ago for
Bipolar II with psychotic delusions. He was
diagnosed with Schizoaffective Disorder, and they
said he had this probably since he was about age
19. He has very angry outbursts and destroyed
a lot of property when he got angry and then he
started getting really delusionary. That is when
I had to call for help for him (and me), as he
became a danger to himself and others at that point. However, ever since he has been on psych
meds, he seems to have no life in him at all.
At least he used to be able to work and make friends. And, now he can't and is very depressed.
He remembers having life and the ability to function, and he just can't do any of those things
any more. He has been certified as 100% disabled
by the Military (the VA), although MHMR will not
certify him as so. I have just written his counsellor with this concern as I myself wonder
and have confronted his counselor with the accusation that I believed all they were doing was
giving my son some form of chemical lobotomy.
I don't know much about this condition in children, as my son's doctor told us that Bipolar
usually does not show up til the late teens or
early twenties; same for schizophrenia. I wish
I could find better meds or something that would
actually hold out the promise of "healing".
This article was informative and helpful to me.
Thanks!

Posted by: Patricia Williams at June 15, 2009 10:17 AM
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