In Brief: Testing antidepressants: How methods affect results
Testing antidepressants: How methods affect results
In many clinical trials of antidepressants eventually approved by the FDA, there was little or no difference in therapeutic effect between the drug and a placebo. An analysis published in the American Journal of Psychiatry aims at teasing out features of experimental design or choice of patients that made for success or failure of the drug.
The authors examined FDA reports for 52 clinical trials of 9 antidepressants evaluated between 1985 and 2000. On average, the difference between the antidepressant effect and the placebo effect was a modest 3.1 points on a standard rating scale for depressive symptoms. The analysts defined as successful the 26 trials in which the drug-placebo difference was greater than that.
Surprisingly, the average number of subjects was about the same in successful and unsuccessful trials, and subjects took the drug (or placebo) for about the same length of time whether the trial succeeded or failed.