Fluoxetine treatment for obsessive-compulsive disorder in children and adolescents: a placebo-controlled clinical trial.
OBJECTIVE
This study assesses the efficacy and tolerability of fluoxetine in the acute treatment of child and adolescent obsessive-compulsive disorder (OCD) during a 13-week, double-blind, placebo-controlled study.


METHODS
Eligible patients aged 7 to 17 (N = 103) were randomized at a ratio of 2:1 to receive either fluoxetine or placebo. Dosing was initiated at 10 mg daily for 2 weeks, then increased to 20 mg daily. After 4 weeks of treatment, and again after 7 weeks of treatment, non-responders could have their dosage increased by 20 mg daily, for a maximum possible dosage of 60 mg daily. Primary measure of efficacy was improvement in OCD symptoms as measured by the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). All analyses were intent-to-treat.


RESULTS
Fluoxetine was associated with significantly greater improvement in OCD as assessed by the CY-BOCS (p = .026) and other measures than was placebo. Fluoxetine was well tolerated and had a rate of discontinuation for adverse events similar to that of placebo (p = 1.00).


CONCLUSIONS
Fluoxetine 20 to 60 mg daily was effective and well tolerated for treatment of OCD in this pediatric population.
Geller
D A
DA
Pediatric OCD Clinic, McLean Hospital, Belmont, MA, USA.
Hoog
S L
SL
Heiligenstein
J H
JH
Ricardi
R K
RK
Tamura
R
R
Kluszynski
S
S
Jacobson
J G
JG
D000293:Adolescent; D000704:Analysis of Variance; D002648:Child; D003257:Consumer Product Safety; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D009771:Obsessive-Compulsive Disorder / Q000188:drug therapy*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index
D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors