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 disorde r (OCD) during a 13-week, double-blind, placebo-controlled study. Method: E ligible patients aged 7 to 17 (N = 103) were randomized at a ratio of 2:1 t o 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. an d again after 7 weeks of treatment, nonresponders could have their dosage i ncreased by 20 mg daily, for a maximum possible dosage of 60 mg daily. Prim ary measure of efficacy was improvement in OCD symptoms as measured by the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). All analyses we re intent-to-treat. Results: Fluoxetine was associated with significantly g reater improvement in OCD as assessed by the CY-BOCS (p = .026) and other m easures than was placebo. Fluoxetine was well tolerated and had a rate of d iscontinuation for adverse events similar to that of placebo (p = 1.00). Co nclusions: Fluoxetine 20 to 60 mg daily was effective and well tolerated fo r treatment of OCD in this pediatric population.