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Original Articles

Duloxetine in the Prevention of Depressive Recurrences: A Randomized, Double-Blind, Placebo-Controlled Trial

David G. S. Perahia, Giuseppe Maina, Michael E. Thase, Melissa E. Spann, Fujun Wang, Daniel J. Walker, and Michael J. Detke

Published: May 13, 2009

Article Abstract

Objective: To assess the efficacy of duloxetine 60-120 mg once daily in the prevention of depressive recurrence in outpatients with recurrent major depressive disorder (MDD).

Method: Eligible patients with at least 3 episodes of MDD (DSM-IV diagnosis) in the past 5 years received open-label duloxetine 60-120 mg/day for up to 34 weeks. Patients meeting response criteria were then randomly assigned to either duloxetine or placebo for up to 52 weeks of double-blind maintenance treatment. The primary outcome measure was time to recurrence of a major depressive episode. Safety and tolerability were assessed via analysis of treatment-emergent adverse events (TEAEs), vital signs, weight, and laboratory measures. Patients were recruited from 43 study centers in 5 European countries (France, Germany, Italy, Russia, and Sweden) and the United States. The study was conducted from March 2005 to January 2008.

Results: A total of 288 patients were randomly assigned to duloxetine or placebo. Time to a depressive recurrence was significantly longer in duloxetine-treated patients compared with placebo-treated patients (p < .001). During the double-blind maintenance phase, 33.1% of placebo-treated patients experienced a depressive recurrence compared with 14.4% of duloxetine-treated patients (p < .001). There were no significant differences between treatment groups in TEAEs, discontinuations due to adverse events, vital signs, or weight.

Conclusion: Treatment with duloxetine was associated with a longer time to depressive recurrence and a significantly lower recurrence rate compared with placebo.

Trial Registration: clinicaltrials.gov Identifier: NCT00105989

Volume: 70

Quick Links: Depression (MDD)

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Letter to the Editor

Stigma Kills Psychiatric Patients and Is Now Killing Clinical Research Too

Robert M. Post, MD, argues that NIMH should abandon the RDoC framework and restore funding for clinical...

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