Fluoxetine treatment for prevention of relapse of depression in children and adolescents: A double-blind, placebo-controlled study

Graham J. Emslie, John H. Heiligenstein, Sharon L. Hoog, Karen Dineen Wagner, Robert L. Findling, James T. McCracken, Mary E. Nilsson, Jennie G. Jacobson

Research output: Contribution to journalArticle

96 Scopus citations


Objective: To compare fluoxetine 20 to 60 mg/day with placebo for prevention of relapse of major depressive disorder in children and adolescents who had achieved Children's Depression Rating Scale, Revised scores of ≤28 during treatment with fluoxetine 20 to 60 mg. Method: In this 32-week relapse-prevention phase of a double-blind, multicenter, placebo-controlled 51-week study, 20 patients continued to receive their fixed dose of fluoxetine (F/F group), while 20 similar patients were switched to placebo (F/P group). Definition of relapse for the primary analysis was a Children's Depression Rating Scale, Revised score of >40 with a 2-week history of clinical deterioration or relapse in the opinion of the physician. Adverse events were compared between treatment groups to assess discontinuation-emergent adverse events. Results: Mean time to relapse was longer in the F/F recipients than in the F/P recipients (p = .046). Relapse occurred in an estimated 34% in the F/F cohort and 60% in the F/P cohort. Incidence of adverse events and tolerability were similar in the F/F and F/P groups, suggesting that fluoxetine is not associated with significant discontinuation events. Conclusions: Fluoxetine 20 to 60 mg/day was well tolerated and can significantly delay relapse of major depressive disorder symptoms in children and adolescents.

Original languageEnglish (US)
Pages (from-to)1397-1405
Number of pages9
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Issue number11
StatePublished - Nov 2004



  • Fluoxetine
  • Major depressive disorder
  • Relapse

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

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