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NCT00000384 · ClinicalTrials.gov registry record · Phase 3
Treatment of Obsessive-Compulsive Disorder (OCD) in Children
A Phase 3 study of Obsessive - Compulsive Disorder, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 3
- Development phase
- 2
- Study locations
NCT00000384: Completed Phase 3 study of Obsessive - Compulsive Disorder, sponsored by University of Pennsylvania.
NCT00000384 is a Phase 3 study of Obsessive - Compulsive Disorder that has completed, run by University of Pennsylvania. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000384, a Phase 3 study of Obsessive - Compulsive Disorder, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavior Therapy
- DRUG Sertraline
- BEHAVIORAL Educational Support
Study Locations (2)
North Carolina
- Duke Univ. Med. Ctr. - Durham
Pennsylvania
- Univ of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Start Date | 1997-05 |
| Est. Completion | 2002-04 |
| Phase | Phase 3 |
What the finished NCT00000384 record still lists
NCT00000384 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 1 condition, with Obsessive - Compulsive Disorder appearing as the primary indexed condition, and to 3 interventions - of which Cognitive Behavior Therapy is the first listed.
NCT00000384 reports a single indexed study location in North Carolina, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00000384 about?
NCT00000384 is a clinical study titled "Treatment of Obsessive-Compulsive Disorder (OCD) in Children". 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 (...
What is the current status of trial NCT00000384?
This trial is currently completed. It is a Phase 3 study. The study started on 1997-05. Estimated completion is 2002-04.
What conditions does trial NCT00000384 study?
This clinical trial studies the following conditions: Obsessive - Compulsive Disorder.
What interventions are being tested in trial NCT00000384?
The interventions under investigation include: Cognitive Behavior Therapy (BEHAVIORAL), Sertraline (DRUG), Educational Support (BEHAVIORAL).
Who is sponsoring clinical trial NCT00000384?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00000384 being conducted?
This trial has 2 study locations across North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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