PAROXETINE TREATMENT OF GENERALIZED SOCIAL PHOBIA (SOCIAL ANXIETY DISORDER) - A RANDOMIZED CONTROLLED TRIAL

Context.-The generalized type of social phobia (social anxiety disorde r) is a severe and often disabling form of social anxiety that affects approximately 5% of the general population. Earlier research has show n monoamine oxidase inhibitors or benzodiazepines to be effective in t reating this condition, but neither has achieved widespread use. Objec tive.-To compare the efficacy of paroxetine, a selective serotonin reu ptake inhibitor, with placebo in adults with generalized social phobia . Design.-Twelve-week, multicenter, randomized, double-blind trial. Se tting.-Thirteen centers across the United States and 1 in Canada. Part icipants.-Between April 13, 1995, and February 28, 1996, 187 persons m eeting Diagnostic and Statistical Manual of Mental Disorders, Fourth E dition criteria for generalized social phobia were randomized land 183 returned for at least 1 efficacy assessment) to treatment. Interventi on.-After a 1-week, single-blind, placebo, run-in period, patients rec eived a double-blind, 1 I-week course of either paroxetine or matching -image placebo. The initial daily dosage of paroxetine (or placebo) wa s 20 mg with increases of 10 mg/d weekly (flexible dosing to a maximum of 50 mg/d) permitted after the second week of treatment. Main Outcom e Measures.-Number of responders based on the Clinical Global Impressi on Global Improvement Item (''much improved'';or ''very much improved' '); mean change from baseline on the Liebowitz Social Anxiety Scale to tal score. Results.-Fifty (55.0%) of 91 persons taking paroxetine and 22 (23.9%) of 92 persons taking placebo were much improved or very muc h improved at the end of treatment (odds ratio [OR], 3.88; 95% confide nce interval [CI], 2.81-5.36). Mean Liebowitz Social Anxiety Scale tot al scores were reduced by 39.1% (the mean baseline score of 78.0 decli ned by a mean of 30.5 points at follow-up) in the paroxetine group com pared with 17.4% (the mean baseline score of 83.5 declined 14.5 points at follow-up) in the placebo group, a difference of 21.7% (95% CI, 8. 7%-34.7%) favoring paroxetine. Conclusions.-Paroxetine is an effective treatment for patients with generalized social phobia. Short-term (ie , 11-week) treatment results in substantial and clinically meaningful reductions in symptoms and disability. Future research should test whe ther these may be further reduced by extended treatment or supplementa tion with specific educational-cognitive-behavioral techniques.