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NCT00643123 · ClinicalTrials.gov registry record · Phase 4
Allopurinol Add-on Treatment for Refractory Mania
A Phase 4 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT00643123: Completed Phase 4 study, sponsored by Cedars-Sinai Medical Center.
NCT00643123 is a Phase 4 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 40 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
NCT00643123, a Phase 4 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for treatment resistant mania and mixed mania.
Primary Outcome
The YMRS is an 11-item, clinician-administered rating scale to assess the severity of manic symptoms before, during and after treatment. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. A score of 0 indicates the behavior is absent, whereas a score of 4 or 8 indicates the behavior is present and severe. The change in score between Baseline and the Comp
Interventions
- OTHER Placebo
- DRUG Allopurinol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-06 |
| Phase | Phase 4 |
What the finished NCT00643123 record still lists
NCT00643123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 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.
NCT00643123 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00643123 about?
NCT00643123 is a clinical study titled "Allopurinol Add-on Treatment for Refractory Mania". The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for treatment resistant mania and mixed mania.
What is the current status of trial NCT00643123?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2007-09. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00643123?
The interventions under investigation include: Placebo (OTHER), Allopurinol (DRUG).
Who is sponsoring clinical trial NCT00643123?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00643123's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 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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