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Long-term functioning and sleep quality in patients with major depressive disorder treated with extended-release quetiapine fumarate

Sheehan, David V.a; Locklear, Julieb; Svedsäter, Henrikc; Datto, Catherineb

International Clinical Psychopharmacology: September 2012 - Volume 27 - Issue 5 - p 239–248
doi: 10.1097/YIC.0b013e328356ac78
Original Articles

The aim of this study was to assess patients’ functioning and sleep quality during extended-release quetiapine fumarate (quetiapine XR) maintenance treatment. A double-blind, randomized-withdrawal maintenance study of quetiapine XR monotherapy was carried out in patients with major depressive disorder. Following 4–8 weeks of open-label quetiapine XR and 12–18 weeks of open-label quetiapine XR stabilization (50, 150, or 300 mg/day), eligible patients were randomized to quetiapine XR (50, 150, or 300 mg/day) or placebo. Secondary variables of the Sheehan Disability Scale (SDS) and the Pittsburgh Sleep Quality Index (PSQI) were used to assess functioning and sleep quality and are reported here. Quetiapine XR significantly maintained functioning versus placebo. Changes in the least squares means (LSM) from randomization in the SDS total scores were as follows: −0.45, quetiapine XR (P<0.05), versus 0.44, placebo. Quetiapine XR significantly maintained SDS domains ‘social life/leisure’ (−0.19; P<0.05) and ‘family life/home responsibilities’ (−0.22; P<0.05) versus placebo (0.13 and 0.10, respectively). Quetiapine XR significantly maintained sleep quality (LSM change in PSQI total scores: 0.06, quetiapine XR vs. 1.35, placebo; P<0.001), with five of seven PSQI components being significant for quetiapine XR versus placebo. In conclusion, quetiapine XR (50–300 mg/day) monotherapy better maintains overall functioning and sleep quality than placebo in patients with major depressive disorder.

aCollege of Medicine, University of South Florida, Tampa, Florida

bAstraZeneca Pharmaceuticals, Wilmington, Delaware, USA

cformerly AstraZeneca R&D, Mölndal, Sweden

Correspondence to David V. Sheehan, College of Medicine, University of South Florida, Tampa, FL 33613, USA Tel: +1 813 974 1074; fax: +1 813 974 4575; e-mail:

Received August 18, 2011

Accepted June 6, 2012

© 2012 Lippincott Williams & Wilkins, Inc.