Paroxetine treatment in children and adolescents with obsessive-compulsive disorder: a randomized, multicenter, double-blind, placebo-controlled trial

J Am Acad Child Adolesc Psychiatry. 2004 Nov;43(11):1387-96. doi: 10.1097/01.chi.0000138356.29099.f1.


Objective: To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder.

Method: Children (7-11 years of age) and adolescents (12-17 years of age) meeting DSM-IV criteria for obsessive-compulsive disorder were randomized to paroxetine (10-50 mg/day) or placebo for 10 weeks. The primary efficacy measure was change from baseline in the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total score at week 10 last observation carried forward end point. Safety was assessed primarily through adverse event monitoring.

Results: A total of 207 patients were randomized to treatment. Of these, 203 were included in the intention-to-treat population. Adjusted mean changes from baseline at week 10 observation carried forward end point in CY-BOCS total score for patients receiving paroxetine and placebo were -8.78 (SE=0.82) and -5.34 points (SE=0.77), respectively. The adjusted mean difference, -3.45 in favor of paroxetine, was statistically significant (95% confidence interval=-5.60 to -1.29, p=.002). Adverse events were generally mild to moderate in intensity. A total of 10.2% (10/98) of patients in the paroxetine group and 2.9% (3 of 105) in the placebo group discontinued treatment because of adverse events.

Conclusions: Paroxetine is an effective and generally well-tolerated treatment for obsessive-compulsive disorder in children and adolescents.

Publication types

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

MeSH terms

  • Administration, Oral
  • Adolescent
  • Child
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Obsessive-Compulsive Disorder / drug therapy*
  • Paroxetine / administration & dosage
  • Paroxetine / adverse effects
  • Paroxetine / therapeutic use*
  • Placebos
  • Selective Serotonin Reuptake Inhibitors / administration & dosage
  • Selective Serotonin Reuptake Inhibitors / adverse effects
  • Selective Serotonin Reuptake Inhibitors / therapeutic use*
  • Treatment Outcome


  • Placebos
  • Serotonin Uptake Inhibitors
  • Paroxetine