title: Fluoxetine treatment for prevention of relapse of depression in children and adolescents: a double-blind, placebo-controlled study.
abstract: 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 < or =28 during treatment with fluoxetine 20 to 60 mg.
  
  
  METHODS
  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.
authors.affiliation: University of Texas Southwestern Medical Center at Dallas, Texas, USA.
authors.forename: Graham J
authors.initials: GJ
authors.lastname: Emslie
authors.forename: John H
authors.initials: JH
authors.lastname: Heiligenstein
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Hoog
authors.forename: Karen Dineen
authors.initials: KD
authors.lastname: Wagner
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
authors.forename: James T
authors.initials: JT
authors.lastname: McCracken
authors.forename: Mary E
authors.initials: ME
authors.lastname: Nilsson
authors.forename: Jennie G
authors.initials: JG
authors.lastname: Jacobson
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D002648:Child; D003866:Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010919:Placebos; D012008:Recurrence; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D005473:Fluoxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors