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Duloxetine treatment for relapse prevention in adults with generalized anxiety disorder: a double-blind placebo-controlled trial.

Author(s): Davidson JR, Wittchen HU, Llorca PM, Erickson J, Detke M, Ball SG, Russell JM

Affiliation(s): Department of Psychiatry, Duke University Medical School, Durham, NC 27710, USA. jonathan.davidson@duke.edu

Publication date & source: 2008-09, Eur Neuropsychopharmacol., 18(9):673-81. Epub 2008 Jun 17.

Publication type: Clinical Trial; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

The objective was to examine duloxetine 60-120 mg/day treatment for relapse prevention in adults with generalized anxiety disorder (GAD). Adult patients (N=887; mean age=43.3 years; 61.0% female) with DSM-IV-TR-defined GAD diagnosis were treated with duloxetine for 26 weeks. Patients who completed open-label phase and were treatment responders (>or=50% reduction in Hamilton Anxiety Rating Scale total score to <or=11 and "much"/"very much improved" ratings for the last 2 visits of open-label phase) were randomly assigned to receive duloxetine or placebo for a 26-week double-blind continuation phase. Relapse was defined as >or=2-point increase in illness severity ratings or by discontinuation due to lack of efficacy. During the double-blind phase, placebo-treated patients (N=201) relapsed more frequently (41.8%) than duloxetine-treated patients (13.7%, N=204, P<or=0.001) and worsened on each outcome measure (P<or=0.001, all comparisons). Duloxetine 60-120 mg/day treatment was efficacious and reduced risk of relapse in patients with GAD.

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