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Efficacy, safety, and tolerability of fixed-dose desvenlafaxine 50 and 100 mg/day for major depressive disorder in a placebo-controlled trial

Boyer, Patricea; Montgomery, Stuartb; Lepola, Ullac; Germain, Jean-Micheld; Brisard, Claudined; Ganguly, Ritae; Padmanabhan, Sudharshan K.e; Tourian, Karen A.e

International Clinical Psychopharmacology: September 2008 - Volume 23 - Issue 5 - p 243-253
doi: 10.1097/YIC.0b013e32830cebed
ORIGINAL ARTICLES
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The objective of this study was to assess the efficacy, safety, and tolerability of desvenlafaxine (administered as desvenlafaxine succinate) 50 and 100 mg/day for major depressive disorder (MDD). A multicenter, randomized, double-blind, placebo-controlled trial was conducted in Europe and South Africa. Outpatients with MDD received fixed-dose desvenlafaxine (50 or 100 mg/day) or placebo for 8 weeks. The primary efficacy variable was the 17-item Hamilton Rating Scale for Depression total score; secondary measures included Clinical Global Impressions-Improvement scores. The intent-to-treat population included 483 patients: desvenlafaxine 50 mg (n=164), desvenlafaxine 100 mg (n=158), and placebo (n=161). At the last-observation-carried-forward analysis (final evaluation) using analysis of covariance, adjusted mean changes from baseline on the Hamilton Rating Scale for Depression were significantly greater for both desvenlafaxine 50 mg (−13.2; P=0.002) and 100 mg (−13.7; P<0.001) versus placebo (−10.7). Significant differences on the Clinical Global Impressions-Improvement scores were observed for desvenlafaxine 50 mg (P=0.002) and 100 mg (P<0.001) versus placebo. Both doses of desvenlafaxine were generally well tolerated. The most common treatment-emergent adverse events were nausea, dizziness, insomnia, constipation, fatigue, anxiety, and decreased appetite. Fixed doses of desvenlafaxine 50 and 100 mg/day are safe, generally well tolerated, and effective at a clinically relevant level for the treatment of MDD.

aUniversity of Ottawa, Ontario, Canada

bImperial College School of Medicine, London, England

cKuopion Psykiatripalvelu Oy, Kuopio, Finland

dWyeth Research, Paris, France

eWyeth Research, Collegeville, Pennsylvania, USA

Correspondence to Dr Patrice Boyer, MD, PhD, University of Ottawa, Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, Ontario LIZ 7K4, Canada

Tel: +613 722 6521; fax: +613 798 2982; e-mail: pboyer@rohcg.on.ca

Received 6 March 2008 Accepted 16 June 2008

© 2008 Lippincott Williams & Wilkins, Inc.