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Sertraline in Children and Adolescents With Obsessive-Compulsive Disorder
A Multicenter Randomized Controlled Trial
John S. March, MD, MPH;
Joseph Biederman, MD;
Robert Wolkow, MD;
Allan Safferman, MD;
Jack Mardekian, PhD;
Edwin H. Cook, MD;
Neal R. Cutler, MD;
Roberto Dominguez, MD;
James Ferguson, MD;
Betty Muller, MD;
Robert Riesenberg, MD;
Murray Rosenthal, DO;
Floyd R. Sallee, MD, PhD;
Karen D. Wagner, MD, PhD
JAMA. 1998;280:1752-1756.
Context.— The serotonin reuptake inhibitors are the treatment of choice for patients with obsessive-compulsive disorder; however, empirical support for this assertion has been weaker for children and adolescents than for adults.
Objective.— To evaluate the safety and efficacy of the selective serotonin reuptake inhibitor sertraline hydrochloride in children and adolescents with obsessive-compulsive disorder.
Design.— Randomized, double-blind, placebo-controlled trial.
Patients.— One hundred eighty-seven patients: 107 children aged 6 to 12 years and 80 adolescents aged 13 to 17 years randomized to receive either sertraline (53 children, 39 adolescents) or placebo (54 children, 41 adolescents).
Setting.— Twelve US academic and community clinics with experience conducting randomized controlled trials.
Intervention.— Sertraline hydrochloride was titrated to a maximum of 200 mg/d during the first 4 weeks of double-blind therapy, after which patients continued to receive this dosage of medication for 8 more weeks. Control patients received placebo.
Main Outcome Measures.— The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), the National Institute of Mental Health Global Obsessive Compulsive Scale (NIMH GOCS), and the NIMH Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) rating scales.
Results.— In intent-to-treat analyses, patients treated with sertraline showed significantly greater improvement than did placebo-treated patients on the CY-BOCS (adjusted mean, -6.8 vs -3.4, respectively; P = .005), the NIMH GOCS (-2.2 vs -1.3, respectively; P = .02), and the CGI-I (2.7 vs 3.3, respectively; P = .002) scales. Significant differences in efficacy between sertraline and placebo emerged at week 3 and persisted for the duration of the study. Based on CGI-I ratings at end point, 42% of patients receiving sertraline and 26% of patients receiving placebo were very much or much improved. Neither age nor sex predicted response to treatment. The incidence of insomnia, nausea, agitation, and tremor were significantly greater in patients receiving sertraline; 12 (13%) of 92 sertraline-treated patients and 3 (3.2%) of 95 placebo-treated patients discontinued prematurely because of adverse medical events (P = .02). No clinically meaningful abnormalities were apparent on vital sign determinations, laboratory findings, or electrocardiographic measurements.
Conclusion.— Sertraline appears to be a safe and effective short-term treatment for children and adolescents with obsessive-compulsive disorder.
From the Departments of Psychiatry and Psychology, Duke University Medical Center, Durham, NC (Dr March); the Department of Psychiatry, Massachusetts General Hospital, Boston (Dr Biederman); Pfizer Inc, New York, NY (Drs Wolkow, Safferman, and Mardekian); the Departments of Psychiatry and Pediatrics, University of Chicago, Chicago, Ill (Dr Cook); California Clinical Trials, Beverly Hills (Dr Cutler); the Department of Psychiatry, University of Miami, Miami, Fla (Dr Dominguez); Department of Psychiatry, Tulane University, New Orleans, La (Dr Muller); Biobehavioral Research Center, Decatur, Ga (Dr Riesenberg); Department of Psychiatry, Medical University of South Carolina, Charleston (Dr Sallee); and the Department of Psychiatry, University of Texas Medical Branch, Galveston (Dr Wagner). Dr Ferguson is in private practice in Murray, Utah, and Dr Rosenthal is in private practice in San Diego, Calif.
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