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Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: A randomized, double-blind study

Arifulla Khan, MD

Northwest Clinical Research Center, Bellevue, Washington, USA; Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Durham, North Carolina, USA

Sarah Atkinson, MD

Finger Lakes Clinical Research, Rochester, New York, USA

Irina Mezhebovsky, MD

Boston Clinical Trials, Inc., Boston, Massachusetts, USA

Fahua She, MS

AstraZeneca Pharmaceuticals, Wilmington, Delaware, USA

Todd Leathers, MBA

AstraZeneca Pharmaceuticals, Wilmington, Delaware, USA

Sanjeev Pathak, MD

AstraZeneca Pharmaceuticals, Wilmington, Delaware, USA

BACKGROUND: For many patients with generalized anxiety disorder (GAD), first-line treatment does not lead to remission. This study investigated the efficacy and tolerability of adjunctive extended-release quetiapine fumarate (quetiapine XR) in patients with GAD and an inadequate response to selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).

METHODS: Patients were randomized to quetiapine XR or placebo adjunctive to SSRI/SNRIs in an 11-week study. The primary endpoint was change from randomization to week 8 in Hamilton Anxiety Rating Scale (HAM-A) total score. Secondary variables were HAM-A psychic/somatic clusters, response, and remission, and Clinical Global Impression–Severity of Illness (CGI-S) score.

RESULTS: A total of 409 patients received quetiapine XR (n=209) or placebo (n=200). The week 8 mean change in HAM-A total score was not statistically significant for quetiapine XR (–10.74; P=.079) vs placebo (–9.61). Secondary variables were generally consistent with the primary analysis, except for a significant reduction in HAM-A total score (week 1) and significant improvements in HAM-A psychic cluster and CGI-S total scores (week 8). Adverse events included dry mouth, somnolence, sedation, headache, and dizziness.

CONCLUSIONS: In patients with GAD and an inadequate response to SSRI/SNRIs, adjunctive quetiapine XR did not show a statistically significant effect for the primary endpoint at week 8, although some secondary endpoints were statistically significant vs placebo. Quetiapine XR was generally well tolerated.

KEYWORDS: clinical trial, phase 3, anxiety disorders, sustained-release preparations, antipsychotics, treatment efficacy

ANNALS OF CLINICAL PSYCHIATRY 2013;25(4):E7-E22

CORRESPONDENCE: Arifulla Khan, MD Department of Psychiatry and Behavioral Sciences Duke Medical Hospital Northwest Clinical Research Center 1951 152nd Place NE, Suite 200 Bellevue, WA 98007 USA E-MAIL: akhan@nwcrc.net
Annals of Clinical Psychiatry ©2013 Quadrant HealthCom Inc.

 
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