A multicenter, randomized, double-blind, placebo-controlled trial of paroxetine in children and adolescents with social anxiety disorder.

BACKGROUND Social anxiety disorder is a debilitating, highly prevalent disorder in children and adolescents. If left untreated, it can interfere with emotional, social, and school functioning. OBJECTIVE To evaluate the efficacy and tolerability of paroxetine in children and adolescents with social anxiety disorder. DESIGN AND SETTING Multicenter, 16-week, randomized, double-blind, placebo-controlled, flexible-dose, parallel-group, outpatient study. Patients A total of 322 children (8-11 years of age) and adolescents (12-17 years of age) with social anxiety disorder as their predominant psychiatric illness. Intervention Eligible patients were randomized (1:1) to receive paroxetine (10-50 mg/d) or placebo. RESULTS Four hundred twenty-five patients were screened, and 322 were randomized to treatment. Of these, 319 were included in the intention-to-treat population (paroxetine, n = 163; placebo, n = 156). At the week 16 last observation carried forward end point, the odds of responding (Clinical Global Impression-Improvement score of 1 or 2) were statistically significantly greater for paroxetine (77.6% response [125/161]) than for placebo (38.3% response [59/154]) (adjusted odds ratio, 7.02; 95% confidence interval, 4.07 to 12.11; P<.001). The proportion of patients who were "very much" improved (Clinical Global Impression-Improvement score of 1) was 47.8% (77/161) for paroxetine compared with 14.9% (23/154) for placebo. Adverse events occurring at an incidence of 5% or greater for paroxetine and twice that for placebo were insomnia (14.1% vs 5.8%), decreased appetite (8.0% vs 3.2%), and vomiting (6.7% vs 1.9%). Withdrawals due to adverse events were infrequent (5.5% [9/163] for paroxetine and 1.3% [2/156] for placebo). CONCLUSION Paroxetine is an effective, generally well-tolerated treatment for pediatric social anxiety disorder.