title: Double-blind, crossover trial of fluoxetine and placebo in children and adolescents with obsessive-compulsive disorder.
abstract: Rigorously designed clinical trials have demonstrated the efficacy and safety of fluoxetine in adults with major depressive disorder and obsessive-compulsive disorder (OCD) but not in patients below 18 years old. This report describes a randomized, double-blind, placebo-controlled, fixed-dose (20 mg qd) trial of fluoxetine in 14 children and adolescents with OCD, ages 8 to 15 years old; the study was 20 weeks long with crossover at 8 weeks. Obsessive-compulsive symptom severity was measured on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Clinician's Global Impression-Obsessive Compulsive Disorder scale (CGI-OCD). The CY-BOCS total score decreased 44% (N = 7, p = .003) after the initial 8 weeks of fluoxetine treatment, compared with a 27% decrease (N = 6, p = .13) after placebo. During the initial 8 weeks, the magnitude of improvement for the fluoxetine group significantly exceeded that for the placebo group as measured by the CGI-OCD (p = .01) but not by the CY-BOCS (p = .17). The most common drug side effects were generally well tolerated. The results suggest that fluoxetine is a generally safe and effective short-term treatment for children with OCD.
authors.affiliation: Yale Child Study Center, Yale University School of Medicine, New Haven, CT 06510-8009.
authors.forename: M A
authors.initials: MA
authors.lastname: Riddle
authors.forename: L
authors.initials: L
authors.lastname: Scahill
authors.forename: R A
authors.initials: RA
authors.lastname: King
authors.forename: M T
authors.initials: MT
authors.lastname: Hardin
authors.forename: G M
authors.initials: GM
authors.lastname: Anderson
authors.forename: S I
authors.initials: SI
authors.lastname: Ort
authors.forename: J C
authors.initials: JC
authors.lastname: Smith
authors.forename: J F
authors.initials: JF
authors.lastname: Leckman
authors.forename: D J
authors.initials: DJ
authors.lastname: Cohen
mesh_terms: D000293:Adolescent; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009771:Obsessive-Compulsive Disorder / Q000188:drug therapy* / Q000523:psychology; D010552:Personality Assessment
chemical_list: D005473:Fluoxetine