The pediatric obsessive-compulsive disorder treatment study: rationale, design, and methods.
Obsessive-compulsive disorder (OCD), which has a prevalence of 1 in 200 in children and adolescents, carries with it significant functional morbidity. A growing empirical literature supports the efficacy of short-term treatment with OCD-specific cognitive-behavior therapy (CBT) or medication management with a selective serotonin reuptake inhibitor. These and other studies also identify a substantial probability of partial response and, possibly, differences in durability when treatment is discontinued between medication and CBT. The Pediatric OCD Treatment Study is a multicenter, randomized, masked clinical trial designed to evaluate the relative benefit and durability of four treatments for children and adolescents with OCD: sertraline, CBT, combination of sertraline and CBT, and pill placebo. Stage 1 (12 weeks) is a balanced randomized comparison of these four treatments. Responders at the end of stage 1 advance to 4 months of open follow-up in their assigned arm during which all treatment is discontinued. At the end of stage 2 (if not before), nonresponders to any treatment at the end of stage 1, any patient relapsing in stage 2, and all stage 1 placebo patients receive open treatment that is tailored to the patient's needs. A volunteer sample of 120 subjects between the ages of 7 and 17 inclusive with a primary Diagnostic and Statistical Manual of Mental Disorders (fourth edition) diagnosis of OCD enters the study. All patients, regardless of responder status, return for all scheduled assessments. This report describes the design of the trial, the rationale for the design choices made, and the methods used to carry out the trial.
Franklin
Martin
M
Center for the Treatment and Study of Anxiety, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
Foa
Edna
E
March
John S
JS
D000293:Adolescent; D002648:Child; D003627:Data Interpretation, Statistical; D006801:Humans; D015337:Multicenter Studies as Topic; D009771:Obsessive-Compulsive Disorder / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D011569:Psychiatric Status Rating Scales; D011785:Quality Assurance, Health Care; D016032:Randomized Controlled Trials as Topic; D012107:Research Design