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NCT00245635 · ClinicalTrials.gov registry record · Phase 4
Fluoxetine in Pediatric Body Dysmorphic Disorder
A Phase 4 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
NCT00245635: Completed Phase 4 study, sponsored by Montefiore Medical Center.
NCT00245635 is a Phase 4 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 43 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00245635, a Phase 4 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
Study Summary
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.
Primary Outcome
To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome.
Interventions
- DRUG Placebo
- DRUG Fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2004-11 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
What the finished NCT00245635 record still lists
NCT00245635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00245635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00245635 about?
NCT00245635 is a clinical study titled "Fluoxetine in Pediatric Body Dysmorphic Disorder". This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.
What is the current status of trial NCT00245635?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2004-11. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00245635?
The interventions under investigation include: Placebo (DRUG), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT00245635?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00245635's enrollment target sits among peer trials
43 1371st of 2000 higher than 621 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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