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A Pooled Analysis Of Two Placebo-Controlled Trials Of Desvenlafaxine In Major Depressive Disorder., Daniel Z Lieberman, Stuart A Montgomery, Karen A Tourian, Claudine Brisard, Gregory Rosas, Krishna Padmanabhan, Jean-Michel Germain, Bruno Pitrosky

Psychiatry and Behavioral Sciences Faculty Publications

The efficacy, safety, and tolerability of desvenlafaxine (administered as desvenlafaxine succinate) were evaluated in two similarly designed, phase 3, randomized, double-blind, placebo-controlled, venlafaxine-extended-release-referenced, flexible-dose studies of outpatients with a primary diagnosis of major depressive disorder. Owing to a high placebo response, the individual studies were underpowered. Therefore, a post-hoc pooled analysis was performed (desvenlafaxine and placebo data were pooled; venlafaxine extended release data were not, owing to different flexible-dose regimens in the two studies). The primary outcome measure was the change from baseline on the 17-item Hamilton Rating Scale for Depression; the Clinical Global Impressions-Improvement item score was a secondary …