Treatment of Obsessive-Compulsive Disorder (OCD) in Children
Treatment of Pediatric Obsessive-Compulsive Disorder
3 other identifiers
interventional
N/A
1 country
2
Brief Summary
The purpose of this study is to compare 3 treatments for children with OCD: medication (sertraline, SER) alone vs OCD-specific therapy (Cognitive Behavior Therapy, CBT) vs medication plus therapy. Some patients will receive an inactive placebo (PBO) instead of medication and/or Educational Support (ES, non-psychological treatment) instead of therapy. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 1997
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
November 3, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2002
CompletedAugust 22, 2016
November 1, 2005
November 2, 1999
August 19, 2016
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- DSM-IV diagnosed OCD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Duke Univ. Med. Ctr.
Durham, North Carolina, 27710, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 20855047DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edna B. Foa, PhD
- PRINCIPAL INVESTIGATOR
John S. March, MD, MPH
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
November 3, 1999
Study Start
May 1, 1997
Study Completion
April 1, 2002
Last Updated
August 22, 2016
Record last verified: 2005-11