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Duloxetine as an SNRI treatment for generalized anxiety disorder: results from a placebo and active-controlled trial

Hartford, Jamesa; Kornstein, Susanb; Liebowitz, Michaelc; Pigott, Teresad; Russell, Jamese; Detke, Michaele f g; Walker, Daniele; Ball, Susane f; Dunayevich, Eduardoe; Dinkel, Jeffe; Erickson, Janellee

International Clinical Psychopharmacology: May 2007 - Volume 22 - Issue 3 - p 167-174
doi: 10.1097/YIC.0b013e32807fb1b2
ORIGINAL ARTICLES

This study examined the efficacy and tolerability of duloxetine 60–120 mg/day for the treatment of patients with generalized anxiety disorder. This was a multicenter, randomized, double-blind, flexible-dose, placebo and active-controlled (venlafaxine extended-release 75–225 mg/day) trial designed to assess duloxetine 60–120 mg/day during 10 weeks of treatment in adults with Diagnostic and statistical manual of mental disorders-IV-defined generalized anxiety disorder. The primary efficacy outcome measure was mean change from baseline to endpoint in the Hamilton Anxiety Rating Scale total score assessed using analysis of covariance. A total of 487 patients were randomly assigned to duloxetine (n=162), venlafaxine XR (n=164), or placebo (n=161). Significantly greater improvement on the Hamilton Anxiety Rating Scale total score occurred in the duloxetine (P=0.007) and venlafaxine XR (P<0.001) groups compared with the placebo group. Overall discontinuation rates did not differ among the three groups, but adverse event-related discontinuation was significantly higher in the duloxetine (14.2%, P<0.001) and venlafaxine XR (11.0%, P=0.001) groups than in the placebo group (1.9%). During the 2-week drug-tapering phase, discontinuation-emergent adverse events were significantly greater in the venlafaxine XR group (26.9%, P=0.04), but not in the duloxetine group (19.4%, P=0.448) compared with placebo (15.8%). Duloxetine 60–120 mg/day and venlafaxine XR 75–225 mg/day were each efficacious treatments for patients with generalized anxiety disorder.

aCommunity Research, Cincinnati, Ohio

bDepartment of Psychiatry, Virginia Commonwealth University, Richmond, Virginia

cDepartment of Psychiatry, Columbia University School of Medicine, New York

dDepartment of Psychiatry, University of Florida College of Medicine, Gainesville, Florida

eLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN

fDepartment of Psychiatry, Indiana University School of Medicine, Indianapolis, Indiana

gDepartment of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA

Correspondence to Dr James Hartford, MD, Community Research, 4460 Red Bank Expressway, Suite 200, Cincinnati Ohio 45227, USA

Tel: +1 513 721 3868 ext. 150; fax: +1 513 639 7343;

e-mail: jhartford@communityresearch.com

Received 14 September 2006 Accepted 2 January 2007

© 2007 Lippincott Williams & Wilkins, Inc.