Paroxetine in social phobia/social anxiety disorder. Randomised, double-blind, placebo-controlled study. Paroxetine Study Group.

Abstract

Preliminary studies have suggested that paroxetine may be effective in social phobia/social anxiety disorder. To assess the efficacy and tolerability of paroxetine in the acute (12-week) treatment of social phobia. Two-hundred and ninety patients with social phobia were assigned randomly to paroxetine (20-50 mg/day flexible dose) or placebo for 12 weeks of double-blind treatment. Primary efficacy outcomes were the Liebowitz Social Anxiety Scale (LSAS) total score (patient-rated) and the Clinical Global Impression (CGI) scale global improvement item. The secondary efficacy variables included CGI scale severity of illness score and the patient-rated Social Avoidance and Distress Scale. Paroxetine produced a significantly greater reduction in LSAS total score (mean change from baseline: -29.4 v. -15.6; P < or = 0.001) and a greater proportion of responders (score < or = 2 on CGI global improvement) (65.7% v. 32.4%; P < 0.001) compared with placebo at the end of the 12-week study period. Both primary efficacy variables were statistically significant compared with placebo from week 4 onwards. Paroxetine was generally well tolerated. Paroxetine is an effective, well-tolerated treatment for patients with social phobia.