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Original Articles

Extended Release Quetiapine Fumarate Monotherapy in Major Depressive Disorder: A Placebo- and Duloxetine-Controlled Study

Andrew J. Cutler, Stuart A. Montgomery, David Feifel, Arthur Lazarus, Mikael Aström, and Martin Brecher

Published: April 7, 2009

Article Abstract

Objective: To evaluate the efficacy and tolerability of once-daily extended release quetiapine fumarate (quetiapine XR) as monotherapy treatment for major depressive disorder (MDD).

Method: This 8-week (6-week active-treatment, randomized phase; 2-week posttreatment drug-discontinuation/tapering phase), multicenter, double-blind, randomized, parallel-group, placebo- and active-controlled, phase 3 study was conducted between April 2006 and May 2007. In total, 612 patients with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)-defined MDD were randomly assigned to quetiapine XR 150 mg/day or 300 mg/day, duloxetine 60 mg/day (active control), or placebo. The primary endpoint was the change from baseline to week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score.

Results: At week 6, both doses of quetiapine XR (p

Conclusion: Quetiapine XR monotherapy (150 mg/day and 300 mg/day) is effective, with safety and tolerability consistent with the known profile of quetiapine XR, in the treatment of patients with MDD, with onset of symptom improvement demonstrated at week 1.

Trial Registration: clinicaltrials.gov Identifier: NCT00321490

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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