Randomized, placebo-controlled trial of cognitive-behavioral therapy alone or combined with sertraline in the treatment of pediatric obsessive-compulsive disorder.

BACKGROUND: To examine the efficacy of sequential sertraline and cognitive-behavioral therapy (CBT) treatment relative to CBT with pill placebo over 18 weeks in children and adolescents with obsessive-compulsive disorder (OCD).
METHODS: Forty-seven children and adolescents with OCD (Range = 7-17 years) were randomized to 18-weeks of treatment in one of three arms: 1) sertraline at standard dosing + CBT (RegSert + CBT); 2) sertraline titrated slowly but achieving at least 8 weeks on the maximally tolerated daily dose + CBT (SloSert + CBT); or 3) pill placebo + CBT (PBO + CBT). Assessments were conducted at screening, baseline, weeks 1-9, 13, and 17, and post-treatment. Raters and clinicians were blinded to sertraline (but not CBT) randomization status. Primary outcomes included the Children's Yale-Brown Obsessive-Compulsive Scale, and response and remission status. Secondary outcomes included the Child Obsessive Compulsive Impact Scale-Parent/Child, Children's Depression Rating Scale-Revised, Multidimensional Anxiety Scale for Children, and Clinical-Global Impressions-Severity.
RESULTS: All groups exhibited large within-group effects across outcomes. There was no group by time interaction across all outcomes suggesting that group changes over time were comparable.
CONCLUSIONS: Among youth with OCD, there was no evidence that sequentially provided sertraline with CBT differed from those receiving placebo with CBT. CLINICALTRIALSGOV IDENTIFIER: NCT00382291.