Treatment of Obsessive-Compulsive Disorder (OCD) in Children
NCT ID: NCT00000384
Last Updated: 2016-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1997-05-31
2002-04-30
Brief Summary
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One in 200 children suffer from OCD, but few receive appropriate treatment. Both CBT and medication seem to be effective, but their effectiveness, alone and in combination, has not been evaluated.
There are 2 phases to this trial. In Phase I the child will receive 1 of the following 6 treatments for 12 weeks: 1) SER alone; 2) pill PBO alone; 3) CBT alone; 4) SER plus CBT; 5) SER plus ES; 6) pill PBO plus ES. If the child responds to treatment, he/she will go on to Phase II in which the treatment will be slowly reduced, then stopped (discontinued), over time to test the treatment's durability. The child will be evaluated at Weeks 1, 4, 8, 12 (Phase I treatment), and Weeks 16, 20, 24, and 28 (Phase II discontinuation) to see how effective and durable the treatment is in treating your child's OCD.
A child may be eligible for this study if he/she:
Has obsessive-compulsive disorder (OCD) and is 8 - 16 years old.
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Detailed Description
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One in 200 youth suffers from OCD, yet relatively few receive appropriate treatment. Both CBT and medication appear beneficial in controlled studies; however, the relative efficacy of CBT and medication, alone and in combination (COMB) is unknown. Thus, well-designed treatment outcome studies are necessary to improve care for youth with OCD.
The experimental design covers 2 phases. Phase I is a 2 (site) x 2 (SER or pill PBO) x 3 (CBT, ES or non- psychosocial treatment) x 5 (repeated measures) factorial 12-week comparison of SER, CBT, COMB and the control conditions. In Phase II, responders advance to a 16-week discontinuation study to assess treatment durability. The primary outcome measure is the Yale-Brown Obsessive-Compulsive Scale. Assessments blind to treatment status take place at Week 0 (pretreatment); Weeks 1, 4, 8, 12 (Phase I treatment); and Weeks 16, 20, 24 and 28 (Phase II discontinuation). Besides addressing comparative efficacy and durability of the specified treatments, the investigators also examine time-action effects, differential effects on specific aspects of OCD, including functional impairment, and predictors of response to treatment.
Conditions
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Study Design
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TREATMENT
Interventions
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Cognitive Behavior Therapy
Educational Support
Sertraline
Eligibility Criteria
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Inclusion Criteria
Patients must have:
DSM-IV diagnosed OCD.
8 Years
16 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Edna B. Foa, PhD
Role: PRINCIPAL_INVESTIGATOR
John S. March, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Locations
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Duke Univ. Med. Ctr.
Durham, North Carolina, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Garcia AM, Sapyta JJ, Moore PS, Freeman JB, Franklin ME, March JS, Foa EB. Predictors and moderators of treatment outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):1024-33; quiz 1086. doi: 10.1016/j.jaac.2010.06.013. Epub 2010 Sep 6.
Other Identifiers
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