Pharmacotherapy of generalized anxiety disorder: results of duloxetine treatment from a pooled analysis of three clinical trials

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Abstract
Objective: Duloxetine is a serotonergic noradrenergic reuptake inhibitor with demonstrated efficacy in each of three independent studies for treatment of adults with generalized anxiety disorder (GAD). A pooled dataset from all completed trials is provided here to show the most likely clinical outcomes associated with duloxetine treatment for GAD.Research design and methods: Data were summed at the individual patient level from three double-blind, placebo-controlled trials of duloxetine treatment: two were 10-week flexible-dose 60–120 mg/day and one was 9-week fixed dose 60 or 120 mg/day. Inclusion/exclusion criteria were consistent across studies.Main outcome measures: Efficacy measures included the Hamilton Anxiety Scale (HAMA) and Sheehan Disability Scale (SDS). Adverse events were queried at every visit in each study.Results: Patients were randomly assigned to duloxetine (n = 668) or placebo (n = 495) treatment. Mean age was 42.4 years; 65% were female. Duloxetine-treated patients improved sig...