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EXTENDED RELEASE QUETIAPINE FUMARATE IN MAJOR DEPRESSIVE DISORDER: ANALYSIS IN PATIENTS WITH ANXIOUS DEPRESSION

Authors

  • Michael E. Thase M.D.,

    Corresponding author
    • Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania
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  • Koen Demyttenaere M.D., Ph.D.,

    1. Department of Psychiatry, University Hospital Gasthuisberg, Leuven,, Belgium
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    • Koen Demytennaere reports no conflict of interest directly related to the submitted manuscript. He is a board member and has received grants and served as a speaker in capacities unrelated to the manuscript.

  • Willie R. Earley M.D.,

    1. AstraZeneca Pharmaceuticals, Wilmington, Delaware
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  • Urban Gustafsson Ph.D.,

    1. AstraZeneca R&D, Södertälje, Sweden
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    • Urban Gustafsson, Willie Earley, and Hans Eriksson are all employees of AstraZeneca. Mattias Udd was an employee of AstraZeneca at the time this analysis was conceived, conducted, and completed.

  • Mattias Udd M.Sc.,

    1. Former AstraZeneca R&D, Södertälje, Sweden
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  • Hans Eriksson M.D., M.B.A., Ph.D.

    1. AstraZeneca R&D, Södertälje, Sweden
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  • These studies were registered at ClinicalTrials.gov (D1448C00001 study identifier number NCT00320268; D1448C00002 study identifier number NCT00321490).

Correspondence to: Michael E. Thase, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA 19104. E-mail: thase@mail.med.upenn.edu

Abstract

Background

A pooled analysis was performed on data from two studies evaluating the efficacy of once-daily extended-release quetiapine fumarate (quetiapine 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 individual 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 Åsberg 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 (baseline 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 depression reported a somewhat greater incidence of AEs.

Conclusion

Quetiapine XR monotherapy improved symptoms of depression in patients with higher and lower levels of anxiety.

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