Efficacy of desvenlafaxine 50 mg compared with placebo in patients with moderate or severe major depressive disorder: a pooled analysis of six randomized, double-blind, placebo-controlled studies

This study assessed the efficacy of desvenlafaxine 50 mg/day compared with placebo for treating moderate or severe major depressive disorder (MDD). Data were pooled from six double-blind, placebo-controlled, desvenlafaxine 50 mg/day fixed-dose studies in adults with MDD. The primary endpoint was improvement in 17-item Hamilton Rating Scale for Depression (HAM-D-17) scores from baseline at week 8. HAM-D-17 changes were evaluated in patients with moderate (18<HAM-D-17<25) or severe (HAM-D(17)25) MDD at baseline using analysis of covariance with treatment, study, and baseline in the model. The pooled analysis included 2189 patients (desvenlafaxine 50 mg, n=1150; placebo, n=1039). Of those, 694 (32%) patients had severe depression at baseline. Desvenlafaxine improved HAM-D-17 scores versus placebo in patients with either moderate [desvenlafaxine, adjusted mean (+/- SE), -10.26 +/- 0.24; placebo, -8.87 +/- 0.26; P<0.001] or severe MDD (desvenlafaxine, -11.91 +/- 0.40; placebo, -9.85 +/- 0.42; P<0.001). Both moderately and severely depressed patients had significantly higher rates of response and remission with desvenlafaxine treatment compared with placebo (all P's0.029). Results were similar when baseline severity was defined by Montgomery-angstrom sberg Depression Rating Scale or Sheehan Disability Scale scores. Desvenlafaxine 50 mg/day significantly improved depressive symptoms regardless of severity at baseline and was effective in treating both moderate and severe MDD.