DEPRESSION AND ANXIETY 29:574–586 (2012) Research Article EXTENDED RELEASE QUETIAPINE FUMARATE IN MAJOR DEPRESSIVE DISORDER: ANALYSIS IN PATIENTS WITH ANXIOUS DEPRESSION Michael E. Thase, M.D., 1∗ Koen Demyttenaere, M.D., Ph.D., 2 Willie R. Earley, M.D., 3 Urban Gustafsson, Ph.D., 4 Mattias Udd, M.Sc., 5 and Hans Eriksson, M.D., M.B.A., Ph.D. 4 Background: A pooled analysis was performed on data from two studies eval- uating the efficacy of once-daily extended-release quetiapine fumarate (queti- apine XR) monotherapy for patients with major depressive disorder. Through these analyses (based on Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) measures), we aim to further evaluate the efficacy of quetiapine XR in depressed patients with high levels of anxiety symptoms. Methods: Secondary analyses were conducted of pooled indi- vidual patient data from two 8-week (6-week randomized phase, 2-week drug discontinuation phase), double-blind, placebo-controlled studies of quetiapine XR (50–300 mg/day). Outcomes included change from randomization at Week 6 in Montgomery ˚ Asberg Depression Rating Scale (MADRS) total score for patients with anxious and nonanxious depression. Results: Of 968 patients included in the analysis, 788 (81.4%) were classified as anxious depressed (defined as HAM- D anxiety/somatization factor score ≥7) and 180 (18.6%) were nonanxious. For patients with anxious depression and nonanxious depression, statistically significant differences versus placebo in MADRS total score were recorded for quetiapine XR 150 mg/day (−3.24, P < .001 and −4.82, P < .01, respectively) and 300 mg/day (−3.57, P < .001 and −3.39, P < .05, respectively) at Week 6. In the second analysis using an alternate definition of anxious depression (base- line HAM-A total score ≥20), quetiapine XR 150 and 300 mg/day resulted in significant differences versus placebo in MADRS total score reduction in patients with high and lower levels of anxiety. The adverse event (AE) profile was similar irrespective of baseline anxiety levels, although patients with anxious depres- sion reported a somewhat greater incidence of AEs. Conclusion: Quetiapine XR 1 Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania 2 Department of Psychiatry, University Hospital Gasthuisberg, Leuven, Belgium 3 AstraZeneca Pharmaceuticals, Wilmington, Delaware 4 AstraZeneca R&D, S ¨ odert¨ alje, Sweden 5 Former AstraZeneca R&D, S ¨ odert¨ alje, Sweden These studies were registered at ClinicalTrials.gov (D1448C00001 study identifier number NCT00320268; D1448C00002 study iden- tifier number NCT00321490). Koen Demytennaere reports no conflict of interest directly related to the submitted manuscript. He is a board member and has re- ceived grants and served as a speaker in capacities unrelated to the manuscript. Urban Gustafsson, Willie Earley, and Hans Eriksson are all employ- ees of AstraZeneca. Mattias Udd was an employee of AstraZeneca at the time this analysis was conceived, conducted, and completed. ∗ Correspondence to: Michael E. Thase, Department of Psy- chiatry, Perelman School of Medicine, University of Pennsylva- nia, 3535 Market Street, Suite 670, Philadelphia, PA 19104. E-mail: thase@mail.med.upenn.edu Received for publication 13 September 2011; Revised 26 April 2012; Accepted 12 May 2012 DOI 10.1002/da.21970 Published online in Wiley Online Library (wileyonlinelibrary.com). C  2012 Wiley Periodicals, Inc.