Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00550394 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults
A Phase 4 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT00550394: Completed Phase 4 study, sponsored by University of Cincinnati.
NCT00550394 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 56 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00550394, a Phase 4 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and to study the effects (both good and bad) of combining quetiapine and topiramate for reducing use of alcohol.
Primary Outcome
Change in self-reported drinks/day (drinks consumed divided by the number of days during that study period).
Interventions
- DRUG Quetiapine and Topiramate
- DRUG quetiapine and placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-06 |
| Phase | Phase 4 |
What the finished NCT00550394 record still lists
NCT00550394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Quetiapine and Topiramate is the first listed.
NCT00550394 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00550394 about?
NCT00550394 is a clinical study titled "Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults". The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless beha...
What is the current status of trial NCT00550394?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2008-04. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00550394?
The interventions under investigation include: Quetiapine and Topiramate (DRUG), quetiapine and placebo (DRUG).
Who is sponsoring clinical trial NCT00550394?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00550394's enrollment target sits among peer trials
56 1213th of 2000 higher than 783 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02287428 · 56 participants · Phase 1
Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
- NCT02923011 · 56 participants · Phase 3
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
- NCT02935283 · 56 participants
Neuroimaging and Neuropsychological Outcomes in Urea Cycle Disorders
- NCT03375866 · 56 participants · NA
Effects of Mixed Nut Consumption on Satiety and Weight Management
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia