A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Paroxetine in Children and Adolescents With Social Anxiety Disorder

Arch Gen Psychiatry. 2004 Nov;61(11):1153-62. doi: 10.1001/archpsyc.61.11.1153.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Age Factors
  • Ambulatory Care
  • Child
  • Double-Blind Method
  • Drug Administration Schedule
  • Feeding and Eating Disorders / chemically induced
  • Female
  • Humans
  • Male
  • Paroxetine / administration & dosage
  • Paroxetine / adverse effects
  • Paroxetine / therapeutic use*
  • Personality Inventory
  • Phobic Disorders / diagnosis
  • Phobic Disorders / drug therapy*
  • Phobic Disorders / psychology
  • Placebos
  • Psychiatric Status Rating Scales
  • Serotonin Uptake Inhibitors / administration & dosage
  • Serotonin Uptake Inhibitors / adverse effects
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Sleep Initiation and Maintenance Disorders / chemically induced
  • Treatment Outcome
  • Vomiting / chemically induced

Substances

  • Placebos
  • Serotonin Uptake Inhibitors
  • Paroxetine