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Efficacy of extended release quetiapine fumarate monotherapy in patients with major depressive disorder: a pooled analysis of two 6-week, double-blind, placebo-controlled studies

Weisler, Richard H.a,b; Montgomery, Stuart A.c; Earley, Willie R.d; Szamosi, Johane; Lazarus, Arthurd

International Clinical Psychopharmacology: January 2012 - Volume 27 - Issue 1 - p 27–39
doi: 10.1097/YIC.0b013e32834d6f91
Original Articles

Prospectively planned pooled analysis evaluating the efficacy of quetiapine extended release (XR) monotherapy in major depressive disorder (MDD). Data were pooled from two 6-week, randomized, double-blind, placebo-controlled studies of quetiapine XR in outpatients with MDD. The primary endpoint was Montgomery-Åsberg Depression Rating Scale (MADRS) total score change from randomization at week 6. Other evaluations were MADRS response/remission, Hamilton Rating Scale for Anxiety, and subgroup analyses. A total of 968 patients were randomized to quetiapine XR, 150 mg/day (n=315), 300 mg/day (n=323), or placebo (n=330). The mean MADRS total score reductions from randomization were significant at week 6 with quetiapine XR, 150 mg/day (−14.7; P<0.001) and 300 mg/day (−14.7; P<0.001) versus placebo (−11.1), with significant reductions versus placebo from week 1 onward. Response rates (week 6): 52.7% (P<0.001) quetiapine XR 150 mg/day and 49.5% (P<0.001) quetiapine XR 300 mg/day versus placebo (33.0%). MADRS remission (score ≤8; week 6): 23.5% (P=0.208) quetiapine XR 150 mg/day and 28.8% (P<0.01) quetiapine XR 300 mg/day versus placebo (19.4%). Quetiapine XR (both doses) significantly improved eight of 10 MADRS items versus placebo at week 6. The therapeutic effect of quetiapine XR was neither limited to nor driven by factors such as sex, age, or severity of depression. In patients with MDD, quetiapine XR (150 and 300 mg/day) monotherapy reduced depressive symptoms, with significant improvements compared with placebo from week 1 onward.

aDepartment of Psychiatry, University of North Carolina at Chapel Hill, Raleigh

bDepartment of Psychiatry and Behavioral Science, Duke University Medical Center, Durham, North Carolina, USA

cEmeritus Professor of Psychiatry, Imperial College, University of London, London, UK

dAstraZeneca Pharmaceuticals, Wilmington, Delaware, USA

eAstraZeneca R&D Södertälje, Sweden

Poster presented at the 47th American College of Neuropsychopharmacology Annual Meeting, Scottsdale, AZ, USA, 7–11 December 2008

Poster presented at the 17th European Congress of Psychiatry, Lisbon, Portugal, 24–28 January 2009.

Correspondence to Adjunct Professor Richard H. Weisler, Department of Psychiatry, University of North Carolina at Chapel Hill and Duke University Medical Center Suite 125, 700 Spring Forest, Raleigh, NC 27609, USA Tel: +1 919 872 5900; fax: +1 919 878 0942; e-mail:

Received April 27, 2011

Accepted September 22, 2011

© 2012 Lippincott Williams & Wilkins, Inc.