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Media error stuns Prozac investigator. (Placebo Study).

Dr. Helen S. Mayberg was looking forward to hearing reaction to her study comparing the effects of placebo with those of fluoxetine in depressed men, but she didn't expect what came next.

In the double-blind study of 17 previously unmedicated depressed men, Dr. Mayberg and her colleagues found that while placebo and fluoxetine were comparably associated with specific brain changes in glucose metabolism, fluoxetine yielded further, unique changes in the brain. But the lay press broadly misinterpreted the study to say that placebo was just as effective as fluoxetine.

"After thousands of studies, hundreds of millions of prescriptions, and tens of billions of dollars in sales, two things are certain about pills that treat depression: Antidepressants like Prozac, Paxil, and Zoloft work. And so do sugar pills," stated a Washington Post article that started the avalanche of coverage. Like most of the mainstream media coverage, the Post article glossed over the part of the study findings about fluoxetine's additional, unique brain changes.

"It's actually been quite scary," said Dr. Mayberg, who said she felt the entire study was taken out of context for millions of unsuspecting readers and viewers. "I think surreal would be the best way to describe it.

"People got so focused on the results of the placebo. That's not even my area, but it became the whole linchpin of the coverage," remarked Dr. Mayberg, who heads the Sandra A. Rotman program in neuropsychiatry at the University of Toronto.

"The bigger question I was trying to get at--and that this small study begins to look at--is that we need new ways in which to use information from the brain to be able to make rational decisions about how to medicate mentally ill people."

The patients participating in the 6-week study had been given a DSM-IV diagnosis of unipolar major depression and were randomly assigned to 20 mg of fluoxetine per day or placebo. Regional brain glucose metabolism was measured using positron emission tomography before and after the first and last weeks of treatment.

Response to treatment was defined as a minimum 50% decrease from baseline in Hamilton Depression Rating Scale scores. Eight of the patients who completed the study experienced symptom remission. At the end of the study, it was revealed that half of those who responded had been treated with placebo (Am. J. Psychiatry 159[5]:723-37, 2002).

While the researchers noted unique changes in the brainstem, striatum, and hippocampus with fluoxetine, they found a common pattern of reciprocal changes in specific cortical and paralimbic regions with both placebo and the active drug.

Dr. Mayberg said she was not surprised at the changes patients registered on placebo, or that they showed further, unique changes with fluoxetine. The patients, who participated in the study on an inpatient basis, appeared to benefit from daily interactions with their treating physician as well as from group therapy "These findings have important implications for more specific types of nonpharmacological therapies that explicitly target maladaptive cognitive processing," the investigators reported.

"While it was a small trial, the purpose of our experiment was to have a control group that would allow us to understand brain changes with two different levels of treatment with everything else exposed," she said.
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Article Details
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Author:Perlstein, Steve
Publication:Clinical Psychiatry News
Article Type:Brief Article
Geographic Code:1USA
Date:Jun 1, 2002
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