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

Abstract

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.

• Authors: Daniel A Geller, Karen Dineen Wagner, Graham Emslie, Tanya Murphy, David J Carpenter, Erica Wetherhold, Phil Perera, Andrea Machin, Christel Gardiner
• Journal: Journal of the American Academy of Child and Adolescent Psychiatry (J Am Acad Child Adolesc Psychiatry) Vol. 43 Issue 11 Pg. 1387-96 (Nov 2004) ISSN: 0890-8567 [Print] United States
• PMID: 15502598 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Serotonin Uptake Inhibitors
• Paroxetine

Topics

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