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Four placebo-controlled studies have evaluated pregabalin in generalized anxiety disorder (Montgomery et al. 2006; Pande et al. 2003; Pohl et al. 2005; Rickels et al. 2005). In the first study (Pande et al. 2003), 276 patients with generalized anxiety disorder were randomly assigned to pregabalin 150 or 600 mg/day, lorazepam 6 mg/day, or placebo. The 6-week trial included a 1-week placebo lead-in, 4 weeks of blind treatment, and a 1-week taper. The primary efficacy outcome measure was the endpoint Hamilton Anxiety Scale (Ham-A) score. The mean baseline-to-endpoint decrease in Ham-A total score in all three active-treatment groups (pregabalin 150 mg/day, pregabalin 600 mg/day, and lorazepam 6 mg/day) was significantly greater than the decrease in the placebo group. Percentages of subjects who met a secondary outcome measure, a reduction of 50% or greater in the Ham-A score, were significantly higher in the pregabalin 600-mg/day group (46%) and the lorazepam group (61%) than in the placebo group (27%). There were no significant differences in response rates by either definition between patients receiving pregabalin 150 mg/day and patients receiving placebo.

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