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Antidepressant drug trials turn away most of the depressed population. A reason why drug trials are flawed.

Studies establishing the effectiveness of antidepressants are based on highly selective samples of depressed patients. New research by Brown University psychiatrists found as many as 85 percent of depressed patients treated in an outpatient setting would be excluded from the typical study to determine whether an antidepressant works.

Trials to determine the effectiveness of antidepressants have historically evaluated only a small subset of depressed individuals with a very specific clinical profile. People diagnosed with other psychiatric problems and people with mild depression are among those excluded, says the study, which appears in the March 2002 American Journal of Psychiatry.

“When you take any medicine you assume it’s been found to be effective for your condition,” said Mark Zimmerman, associate professor of psychiatry and human behavior, director of outpatient psychiatry at Rhode Island Hospital, and the study’s lead researcher. “No one knows for sure whether antidepressants are effective for most of the patients we treat.”

“Drug companies are concerned that individuals with mild depression will respond just as well to a placebo as they will to antidepressant medication,” said Zimmerman. “However, this represents a sizable number of individuals who are prescribed these medicines, especially by primary care physicians.”

“Drug companies have been correct in assuming that if they show their medicine works for a highly select group of depressed patients, physicians will use it for all patients,” said Zimmerman.

http://www.brown.edu/Administration/...02/01-091.html