Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: the Pediatric OCD Treatment Study (POTS) randomized controlled trial.
Pediatric OCD Treatment Study (POTS) was a randomized placebo-controlled trial designed to evaluate the efficacy of CBT, sertraline, and their combination in the treatment of OCD in children and adolescents. CBT combined with sertraline was superior to either treatment individually, and all treatments were superior to placebo. 53.6% of patients receiving combination therapy achieved remission, compared with 3.6% of patients taking placebo. Side effects such as GI upset were more frequent in patients taking sertraline than placebo, but treatments were generally well tolerated.
- N=112 patients, ages 7-17, with DSM-IV diagnosis of OCD and a Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score ≥16 were randomized to receive 12 weeks of:
- CBT alone (n=28)
- Sertraline alone (n=28)
- Combined CBT & sertraline (n=28)
- Placebo pill (n=28)
- Setting: 3 academic centers in the United States, recruited from 1997-2002.
- Primary outcomes: change in CY-BOCS score over 12 weeks. Remission defined as CY-BOCS score ≤10.
- All three treatment groups showed significant advantage in CY-BOCS score over placebo.
- Combined treatment was associated with greater improvement in CY-BOCS score when compared with both CBT alone (P=0.008) and sertraline alone (P=0.006).
- CBT alone and sertraline alone did not differ significantly (P=0.80).
- Rate of clinical remission, defined as CY-BOCS score ≤10 (95% CI):
- 53.6% for combo (36-70%)
- 39.3% for CBT (24-58%)
- 21.4% for sertraline (10-40%)
- 3.6% for placebo (0-19%)
- While treatments were generally well tolerated, adverse events occurred more frequently with sertraline vs placebo (number of occurrences per number of participants):
- Nausea: 7/28 vs 1/28
- Stomachache: 8/28 vs 2/28
- Diarrhea: 6/28 vs 1/28
- There were no serious adverse events during the study, and no patient became suicidal or made a suicide attempt.
Pediatric OCD Treatment Study (POTS) Team. Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: the Pediatric OCD Treatment Study (POTS) randomized controlled trial. JAMA. 2004;292(16):1969-1976. doi:10.1001/jama.292.16.1969.