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The 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:https://doi.org/10.1001/jama.292.16.1969
The Pediatric OCD Treatment Study (POTS) Team: Principal investigators: Duke University
Medical Center: John S. March, MD, MPH; University
of Pennsylvania: Edna Foa, PhD; Coinvestigators: Duke University Medical Center: Pat Gammon, PhD, Allan
Chrisman, MD, John Curry, PhD, David Fitzgerald, PhD, Kevin Sullivan, BA; University of Pennsylvania: Martin Franklin, PhD, Jonathan
Huppert, PhD, Moira Rynn, MD, Ning Zhao, PhD, Lori Zoellner, PhD; Brown University: Henrietta Leonard, MD, Abbe Garcia, PhD, Jennifer
Freeman, PhD; Principal Statistician: Xin Tu, PhD
(University of Pennsylvania).
Context The empirical literature on treatment of obsessive-compulsive disorder
(OCD) in children and adolescents supports the efficacy of short-term OCD-specific
cognitive-behavior therapy (CBT) or medical management with selective serotonin
reuptake inhibitors. However, little is known about their relative and combined
Objective To evaluate the efficacy of CBT alone and medical management with the
selective serotonin reuptake inhibitor sertraline alone, or CBT and sertraline
combined, as initial treatment for children and adolescents with OCD.
Design, Setting, and Participants The Pediatric OCD Treatment Study, a balanced, masked randomized controlled
trial conducted in 3 academic centers in the United States and enrolling a
volunteer outpatient sample of 112 patients aged 7 through 17 years with a
primary Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition diagnosis of OCD and a Children’s Yale-Brown Obsessive-Compulsive
Scale (CY-BOCS) score of 16 or higher. Patients were recruited between September
1997 and December 2002.
Interventions Participants were randomly assigned to receive CBT alone, sertraline
alone, combined CBT and sertraline, or pill placebo for 12 weeks.
Main Outcome Measures Change in CY-BOCS score over 12 weeks as rated by an independent evaluator
masked to treatment status; rate of clinical remission defined as a CY-BOCS
score less than or equal to 10.
Results Ninety-seven of 112 patients (87%) completed the full 12 weeks of treatment.
Intent-to-treat random regression analyses indicated a statistically significant
advantage for CBT alone (P = .003), sertraline
alone (P = .007), and combined treatment
(P = .001) compared with placebo. Combined
treatment also proved superior to CBT alone (P = .008)
and to sertraline alone (P = .006), which
did not differ from each other. Site differences emerged for CBT and sertraline
but not for combined treatment, suggesting that combined treatment is less
susceptible to setting-specific variations. The rate of clinical remission
for combined treatment was 53.6% (95% confidence interval [CI], 36%-70%);
for CBT alone, 39.3% (95% CI, 24%-58%); for sertraline alone, 21.4% (95% CI,
10%-40%); and for placebo, 3.6% (95% CI, 0%-19%). The remission rate for combined
treatment did not differ from that for CBT alone (P = .42)
but did differ from sertraline alone (P = .03)
and from placebo (P<.001). CBT alone did not differ
from sertraline alone (P = .24) but did
differ from placebo (P = .002), whereas
sertraline alone did not (P = .10). The
3 active treatments proved acceptable and well tolerated, with no evidence
of treatment-emergent harm to self or to others.
Conclusion Children and adolescents with OCD should begin treatment with the combination
of CBT plus a selective serotonin reuptake inhibitor or CBT alone.
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