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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

Papakostas, George I.a; Culpepper, Larryb; Fayyad, Rana S.c; Musgnung, Jeffc; Guico-Pabia, Christine J.c

International Clinical Psychopharmacology: November 2013 - Volume 28 - Issue 6 - p 312–321
doi: 10.1097/YIC.0b013e3283638fbd
Original Articles

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-D17) scores from baseline at week 8. HAM-D17 changes were evaluated in patients with moderate (18<HAM-D17<25) or severe (HAM-D17≥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-D17 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’s≤0.029). Results were similar when baseline severity was defined by Montgomery–Åsberg 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.

aMassachusetts General Hospital, Harvard Medical School

bDepartment of Family Medicine, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts

cPfizer Inc., Collegeville, Pennsylvania, USA

Correspondence to George I. Papakostas, MD, Massachusetts General Hospital, Depression Clinical and Research Program, 50 Staniford Street, 6th floor, Boston, MA 02114, USA Tel: +1 617 726 8895; fax: +1 617 726 7541; e-mail: gpapakostas@partners.org

Received January 11, 2013

Accepted May 22, 2013

© 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins