Fluoxetine for Acute Treatment of Depression in Children and Adolescents: A Placebo-Controlled, Randomized Clinical Trial

Graham J. Emslie, John H. Heiligenstein, Karen Dineen Wagner, Sharon L. Hoog, Daniel E. Ernest, Eileen Brown, Mary Nilsson, Jennie G. Jacobson

Research output: Contribution to journalArticlepeer-review

495 Scopus citations


Background: This report presents results from the acute treatment phase of a clinical trial designed to confirm efficacy of a fixed dose of 20 mg of fluoxetine in children and adolescents with major depressive disorder (MDD). Method: After a 3-week screening period, 122 children and 97 adolescents with MDD (DSM-IV) were randomly assigned to placebo or fluoxetine. After a 1-week placebo lead-in, fluoxetine-treated patients received fluoxetine 10 mg/day for 1 week, then fluoxetine 20 mg/day for 8 weeks. Results: Fluoxetine was associated with greater mean improvement in Children's Depression Rating Scale-Revised (CDRS-R) score than placebo after 1 week (p < .05) and throughout the study period. Significantly more fluoxetine-treated patients (41%) met the prospectively defined criteria for remission than did placebo-treated patients (20%) (p < .01). More fluoxetine- (65%) than placebo-treated (53%) patients met the prospectively defined response criterion of ≥30% decrease in CDRS-R score, but this difference was not significant (p = .093). Significantly more fluoxetine- than placebo-treated patients completed acute treatment (p = .001). There were no significant differences between treatment groups in discontinuations due to adverse events (p = .408). Conclusion: Fluoxetine 20 mg daily appears to be well tolerated and effective for acute treatment of MDD in child and adolescent outpatients. Fluoxetine is the only antidepressant that has demonstrated efficacy in two placebo-controlled, randomized clinical trials of pediatric depression.

Original languageEnglish (US)
Pages (from-to)1205-1215
Number of pages11
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Issue number10
StatePublished - Oct 2002


  • Fluoxetine
  • Major depressive disorder
  • Selective serotonin reuptake inhibitor

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health


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