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.