Predictors and moderators of treatment outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I).
Abbe Marrs Garcia, Jeffrey J Sapyta, Phoebe S Moore...
https://pubmed.ncbi.nlm.nih.gov/20855047Completed
Phase 3
Age: 8Years - 16Years
All Genders
ID00000384
Treatment of Pediatric Obsessive-Compulsive Disorder
Led by University of Pennsylvania · Updated on 2016-08-22
N/A
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Obsessive-Compulsive Disorder (OCD) in Children
Who Can Participate
Age: 8Years - 16Years
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria:
-
Patients must have:
DSM-IV diagnosed OCD.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 2 locations
1
Duke Univ. Med. Ctr.
Durham, North Carolina, United States, 27710
Status Unknown
2
Univ of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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