October 24, 2006

An Interesting OCD Study

A reader passed along a University of Florida study, just in the recruitment phase, that will both try to measure increased agitation and suicidality in kids and teens (ages 7 to 17) taking Zoloft for obsessive-compulsive disorder, and create a behavioral model to scientifically assess agitation and suicidality in such patients.

Zoloft is one of the SSRIs that carries a black box warning for the risk of increased suicidality in adults and youngsters. Its only approved use in people younger than 18 is for OCD. It is not approved for use in treating depression and such in this population.

So, if a drug is linked with suicides and suicidal ideation in youth, then why would you even need to test what problems it might present with youth who are not depressed? Isn't this just courting disaster?

If there's one thing I have learned about researchers over the years, and not simply psych researchers, is that they will study literally every possible question around literally every substance on earth and how it interacts with humans. That's good in some ways. Scientific inquiry should be encouraged. But sometimes it leads to plenty of studies where we already have a pretty decent idea what the answer will be. Researchers can always make the case that even though an answer is known, it is not known with scientific precision (or at least not the kind researchers prefer) and therefore it must be studied. Besides, they can get grant money for the research. And if you are a researcher who's under pressure to drum up research dollars for your university, then you'll chase the money. Or be out of a job. Seriously, academic science is cut throat like that these days.

I think that's what we have going on with this study. But it still makes me uneasy. My hunch is that if this study shows that there is no connection between Zoloft and suicidality, etc. in the young OCD study group, then we will see headlines and media mentions that "Zoloft doesn't cause suicide after all, researchers at the University of Florida announced today." What the articles won't mention is that this is a study group of about 140 youth and that the larger population upon which all the bad news was predicated involved hundreds of thousands of people. Maybe I am weird, but I consider that more solid evidence than whatever you might get from a 140 patient study group.

Stay tuned.

NOTE: The study's principal investigator, Wayne Goodman, recently showed up in a "New York Times article about conflict of interest (ie, getting pharma money) amongst researchers who advise government agencies about drug approvals. Dr. Goodman, a major player on the FDA advisory committee on psych meds, appears to be one of those whose hands are clean. Which is good.

Posted by Philip Dawdy at October 24, 2006 12:01 AM
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Comments

My daughter was dx OCD in 1999 and placed on Luvox, then Zoloft. At age 13, she was on 150mg per day of Zoloft. FDA guidelines are 200 mg per day.
No psychiatrist ever suggested CBT (cognitive behav.therapy) as the least invasive form of therapy.
Psychiatrists then and now are happy to write rx for patients as young as 4 yrs old, this verified by myself as a parent inside the psych wards since 1999.

These children are the future.

When one fights a battle, let the grounds be based on our own struggles to prevent painful outcomes for the next generation.

This, should be all of our goals.

These faces, the young children.

Blaze a good trail for them, they need us to do that for them.

If anyone is interested in this study:

Be assured, that I have made a phone call to the University, and they assure me, that no child will suffer at the expense of this important trial.

As many of you know, my daughter has been through a lot.

What the next generation deserves:

CBT vs. Medications.

This study is attempting to prove it.

~ Stephany,

Peace.

Posted by: Stephany at October 24, 2006 06:34 PM

Side note:

The study will be using Zoloft in this trial, per the FDA guidelines of 200mg per day.

My daughter at age 11 was on 150mg per day and was hospitalized during the withdrawal period, and was out of her mind before the drug was removed.

The reason I called the research team, was to alert them of what happened to my daughter and question why they would medicate children so young; and I was told it is to prove CBT is superior, as a Gold Standard treatment for OCD.

The team assured me they do not want another child to go through what my daughter did.

I trust they will place all safeguards they can in place to watch these children in the study.

It causes a great amount of grief for me to imagine any child suffering like my daughter did on Zoloft. Zoloft hands down, was worse than Zyprexa for her, and that's a hard stat to beat.

Posted by: Stephany at October 25, 2006 09:11 AM

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