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Open Access Research article

A double-blind, randomized, placebo-controlled study assessing the efficacy and tolerability of desvenlafaxine 10 and 50 mg/day in adult outpatients with major depressive disorder

Michael R Liebowitz1*, Karen A Tourian2, Eunhee Hwang2, Linda Mele2 and for the Study 3362 Investigators

Author Affiliations

1 Columbia University, 134 East 93rd Street, Suite 201B, New York, NY, 10128, USA

2 Pfizer Inc, 500 Arcola Road, Collegeville, PA, 19426, USA

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BMC Psychiatry 2013, 13:94  doi:10.1186/1471-244X-13-94

Published: 22 March 2013

Abstract

Background

In an effort to establish the lowest effective dose of desvenlafaxine (administered as desvenlafaxine succinate), we assessed the efficacy, safety, and tolerability of 10- and 50-mg/day desvenlafaxine vs placebo for the treatment of major depressive disorder.

Methods

Adult outpatients with DSM-IV–defined major depressive disorder and a 17-item Hamilton Rating Scale for Depression (HAM-D17) total score ≥20 were randomly assigned to receive placebo or desvenlafaxine (10 or 50 mg/day) after a 6- to 14-day single-blind placebo lead-in period in an 8-week, phase 3, fixed-dose trial. The primary efficacy measure was change from baseline in the HAM-D17 score analyzed using analysis of covariance. Efficacy analyses were conducted with the intent-to-treat population, using the last observation carried forward.

Results

The intent-to-treat population included 673 patients. Change from baseline to final evaluation in adjusted HAM-D17 total scores was not significantly different comparing desvenlafaxine 10 mg/day (-9.28) and desvenlafaxine 50 mg/day (-8.92) with placebo (-8.42). There were no differences among treatment groups in the rates of treatment response or remission. Discontinuations due to adverse events occurred in 1.8%, 0.9%, and 1.8% of patients in the placebo and desvenlafaxine 10- and 50-mg/day groups, respectively. Overall rates of treatment-emergent adverse events with both doses were similar to placebo.

Conclusions

Both doses of desvenlafaxine failed to separate from placebo. However, in a companion study reported separately, desvenlafaxine 50 mg, but not 25 mg, separated from placebo. Taken together, these studies suggest that 50 mg is the minimum effective dose of desvenlafaxine for the treatment of major depressive disorder.

ClinicalTrials.gov Identifier

NCT00863798 http://clinicaltrials.gov/ct2/show/NCT00863798?term=00863798&rank=1 webcite.

Keywords:
Depression; Adult; Antidepressive agents; Efficacy; Treatment; Drug safety