Fluoxetine treatment for prevention of relapse of depression in children and adolescents: a double-blind, placebo-controlled study.
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.
Emslie
Graham J
GJ
University of Texas Southwestern Medical Center at Dallas, Texas, USA.
Heiligenstein
John H
JH
Hoog
Sharon L
SL
Wagner
Karen Dineen
KD
Findling
Robert L
RL
McCracken
James T
JT
Nilsson
Mary E
ME
Jacobson
Jennie G
JG
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*
D005473:Fluoxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors