Fluoxetine in children and adolescents with OCD: a placebo-controlled trial

J Am Acad Child Adolesc Psychiatry. 2002 Dec;41(12):1431-8. doi: 10.1097/00004583-200212000-00014.


Objective: To examine the safety and efficacy of fluoxetine in child and adolescent obsessive-compulsive disorder (OCD).

Method: Between 1991 and 1998, 43 patients were randomly assigned to fluoxetine or placebo for 8 weeks. Dosing was fixed for the first 6 weeks (up to 60 mg/day) and then could be increased to 80 mg/day. Responders entered an 8-week maintenance phase. The primary outcome measures were the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Clinical Global Impression-Improvement (CGI-I) scale. Analyses were done on the intent-to-treat sample.

Results: Fluoxetine patients (n = 21) had significantly lower CY-BOCS scores than placebo patients (n = 22) after 16 (but not 8) weeks. Fluoxetine responders (n = 11) had significantly lower CY-BOCS scores than placebo responders (n = 7) after an additional 8 weeks of treatment. After 16 weeks, 57% of fluoxetine (versus 27% of placebo) patients were much or very much improved on the CGI-I scale (p <.05). No patient terminated the study because of adverse medication effects.

Conclusion: Fluoxetine was well tolerated and effective for the treatment of child and adolescent OCD, but fluoxetine's full effect took more than 8 weeks to develop.

Publication types

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

MeSH terms

  • Adolescent
  • Child
  • Dose-Response Relationship, Drug
  • Female
  • Fluoxetine / adverse effects
  • Fluoxetine / therapeutic use*
  • Follow-Up Studies
  • Humans
  • Male
  • Obsessive-Compulsive Disorder / diagnosis
  • Obsessive-Compulsive Disorder / drug therapy*
  • Personality Assessment
  • Selective Serotonin Reuptake Inhibitors / adverse effects
  • Selective Serotonin Reuptake Inhibitors / therapeutic use*


  • Serotonin Uptake Inhibitors
  • Fluoxetine