Journal
NEUROPSYCHOPHARMACOLOGY
Volume 28, Issue 3, Pages 552-557Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/sj.npp.1300059
Keywords
antidepressants; clinical trials; placebo; fixed dose; flexible dose; meta-analysis
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The assumption that the design of an antidepressant clinical trial affects the outcome of that trial is based on sparse data. We sought to examine if the dosing schedule, either a fixed dose or a flexible dose type, in an antidepressant clinical trial affects the frequency with which antidepressants show statistical superiority over placebo, Randomized, placebo-controlled clinical trials of nine antidepressants approved by the Food and Drug Administration between 1985 and 2000 were reviewed. These trials comprised 93 13 depressed patients who participated in 5 1 antidepressant clinical trials consisting of 92 treatment arms with eventual approved doses. In the flexible dose trials, 59.6% (34/57) of the antidepressant treatment arms were statistically significant compared to placebo, whereas in the fixed dose trials only 31.4% (11/35) of the antidepressant treatment arms were statistically significant compared to placebo (x(2) = 6.9, df = 1, p<0.01). These data suggest that the antidepressant dose schedule may influence trial outcome due in part to a significantly lower magnitude of symptom reduction with placebo in flexible dose trials (F=4.08, df = 1, 48, p<0.05) compared to fixed dose trials. Symptom reduction was similar with antidepressants in the flexible and fixed dose trials. Further, the primary function of finding a dose-response relationship was not found among the fixed dose studies.
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