Efficacy of the novel anxiolytic pregabalin in social anxiety disorder: a placebo-controlled, multicenter study.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

Pregabalin is a novel compound in development for the treatment of anxiety disorders. The safety and efficacy of pregabalin for the treatment of social anxiety disorder was evaluated in a double-blind, multicenter clinical trial in which 135 patients were randomized to 10 weeks of double-blind treatment with either pregabalin 150 mg/d. pregabalin 600 mg/d, or placebo. The primary efficacy parameter was change from baseline to end point in the Liebowitz Social Anxiety Scale (LSAS) total score. Safety was assessed through clinical and laboratory monitoring, and recording spontaneously reported adverse events. Ninety-four patients (70%) completed the 11-week double-blind treatment phase. LSAS total score was significantly decreased by pregabalin 600 mg/d treatment compared with placebo (P = 0.024, analysis of covariance). Significant differences (P < or = 0.05) between pregabalin 600 mg/d and placebo were seen on several secondary measures including the LSAS subscales of total fear, total avoidance, social fear, and social avoidance, and the Brief Social Phobia Scale fear subscale. Pregabalin 150 mg/d was not significantly better than placebo on any measures. Somnolence and dizziness were the most frequently occurring adverse events among patients receiving pregabalin 600 mg/d. In conclusion, pregabalin 600 mg/d was an effective and well-tolerated treatment of social anxiety disorder.

Full Text

Duke Authors

Cited Authors

  • Pande, AC; Feltner, DE; Jefferson, JW; Davidson, JRT; Pollack, M; Stein, MB; Lydiard, RB; Futterer, R; Robinson, P; Slomkowski, M; DuBoff, E; Phelps, M; Janney, CA; Werth, JL

Published Date

  • April 2004

Published In

Volume / Issue

  • 24 / 2

Start / End Page

  • 141 - 149

PubMed ID

  • 15206660

International Standard Serial Number (ISSN)

  • 0271-0749

Digital Object Identifier (DOI)

  • 10.1097/01.jcp.0000117423.05703.e7


  • eng

Conference Location

  • United States