SERTRALINE IN CHILDREN AND ADOLESCENTS WITH OBSESSIVE-COMPULSIVE DISORDER - A MULTICENTER RANDOMIZED CONTROLLED TRIAL

Context.-The serotonin reuptake inhibitors are the treatment of choice for patients with obsessive-compulsive disorder; however, empirical s upport for this assertion has been weaker for children and adolescents than far adults. Objective.-To evaluate the safety and efficacy of th e selective serotonin reuptake inhibitor sertraline hydrochloride in c hildren and adolescents with obsessive-compulsive disorder. Design.-Ra ndomized, double-blind, placebo-controlled trial. Patients.-One hundre d eighty-seven patients: 107 children aged 6 to 12 years and 80 adoles cents aged 13 to 17 years randomized to receive either sertraline (53 children, 39 adolescents) or placebo (54 children, 41 adolescents). Se tting.-Twelve US academic and community clinics with experience conduc ting randomized controlled trials. Intervention.-Sertraline hydrochlor ide 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 d osage of medication for 8 move weeks. Control patients received placeb o. Main Outcome Measures.-The Children's Yale-Brown Obsessive Compulsi ve Scale (CY-BOCS), the National institute of Mental Health Global Obs essive ;Compulsive Scale (NIMH GOCS), and the NIMH Clinical Global Imp ressions of Severity of Illness (CGI-S) and Improvement (CGI-I) rating scales. Results.-In intent-to-treat analyses, patients treated with s ertraline showed significantly greater improvement than did placebo-tr eated patients on the CY-BOCS (adjusted mean, -6.8 vs -3.4, respective ly; P = .005), the NIMH GOCS (-2.2 vs -1.3, respectively; P = .02), an d the CGI-I (2.7 vs 3.3, respectively; P = .002) scales. Significant d ifferences 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 se x 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%) o f 95 placebo-treated patients discontinued prematurely because of adve rse medical events (P =.02). No clinically meaningful abnormalities we re apparent on vital sign determinations, laboratory findings, or elec trocardiographic measurements. Conclusion.-Sertraline appears to be a safe and effective short-term treatment for children and adolescents w ith obsessive-compulsive disorder.