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NCT00864123 · ClinicalTrials.gov registry record · Phase 2
D-Cycloserine Augmentation of Therapy for Pediatric Obsessive-Compulsive Disorder
A Phase 2 study, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00864123: Completed Phase 2 study, sponsored by University of South Florida.
NCT00864123 is a Phase 2 study that has completed, run by University of South Florida. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00864123, a Phase 2 study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Cognitive-behavioral therapy (CBT) has proven efficacy for treatment of pediatric obsessive-compulsive disorder (OCD). Yet, CBT does not help all children and those who benefit often remain symptomatic upon treatment completion. Recent clinical trials in adults with other anxiety disorders (acrophobia and social phobia) provided support for using a medication called D-Cycloserine (DCS) to enahnce the outcome of exposure-based psychotherapy. Given this, DCS may augment CBT in youth with OCD, an anxiety disorder that is conceptually similar to acrophobia. With this in mind, the investigators are conducting a randomized, double-blind placebo controlled pilot study of DCS to determine whether it had any short-term clinical benefits on CBT in youth with OCD. Forty children and adolescents (ages 8-17) with a primary diagnosis of OCD will be screened and, should they meet relevant criteria, randomly assigned to one of two treatment conditions: (1) CBT plus DCS, or (2) CBT plus placebo. All patients will receive 10 sessions of CBT A rater will assess participants at 3 separate time points.
Primary Outcome
The CY-BOCS is a 10-item semi-structured measure of obsession and compulsion severity over the previous week. This measure served as the primary outcome index. Scores range from 0-40 with higher scores representing more severe symptoms.
Interventions
- DRUG Placebo pill
- DRUG D-cycloserine
- BEHAVIORAL Cognitive-behavioral therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00864123 record still lists
NCT00864123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo pill is the first listed.
NCT00864123 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00864123 about?
NCT00864123 is a clinical study titled "D-Cycloserine Augmentation of Therapy for Pediatric Obsessive-Compulsive Disorder". Cognitive-behavioral therapy (CBT) has proven efficacy for treatment of pediatric obsessive-compulsive disorder (OCD). Yet, CBT does not help all children and those who benefit often remain symptomatic upon treatment completion. Recent clinical trials in adults with other anxiety disorders (acrophob...
What is the current status of trial NCT00864123?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2008-01. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00864123?
The interventions under investigation include: Placebo pill (DRUG), D-cycloserine (DRUG), Cognitive-behavioral therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT00864123?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00864123's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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