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NCT00592852 · ClinicalTrials.gov registry record · Phase 4
Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT00592852: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00592852 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 13 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00592852, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
This will be a 12-week open-label pilot treatment study for children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) and obsessive-compulsive disorder (OCD) who are adequately mood stabilized on a stable regimen based on standard clinical care. Specific hypotheses are as follows: Hypothesis 1: Children and adolescents with comorbid OCD and BPD who have achieved adequate mood stabilization using a naturalistic clinical practice approach, will benefit from an FDA-approved selective seratonin reuptake inhibitor (SSRI) on their OCD symptoms in a clinically meaningful way without exacerbation of bipolar symptoms.
Primary Outcome
This sale measures impairment on 5 items relating to Obsessions from 0 (none) to 4 (extreme) and 5 item relating to Compulsions from 0 (none) to 4 (extreme). These scores are totaled for a range of 0 (least impaired) to 40 (most impaired).
Interventions
- DRUG fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2005-12 |
| Est. Completion | 2010-09 |
| Phase | Phase 4 |
Why NCT00592852 stopped before completion
NCT00592852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which fluoxetine is the first listed.
NCT00592852 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00592852 about?
NCT00592852 is a clinical study titled "Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder". This will be a 12-week open-label pilot treatment study for children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) and obsessive-compulsive disorder (OCD) who are adequately mood stabilized on a stable regimen based on standard clinical care. Specific hypotheses are...
What is the current status of trial NCT00592852?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2005-12. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00592852?
The interventions under investigation include: fluoxetine (DRUG).
Who is sponsoring clinical trial NCT00592852?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00592852's enrollment target sits among peer trials
13 1910th of 2000 higher than 88 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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