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NCT00394095 · ClinicalTrials.gov registry record · Phase 4
Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine
A Phase 4 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT00394095: Completed Phase 4 study, sponsored by University of Cincinnati.
NCT00394095 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00394095, a Phase 4 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder. The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.
Primary Outcome
For all participants, BMI was computed using Change in BMI \[kg/m2 (weight/height2)\] over 12 weeks from Baseline to Week 12.
Interventions
- DRUG Placebo
- DRUG Topiramate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-09 |
| Phase | Phase 4 |
What the finished NCT00394095 record still lists
NCT00394095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00394095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00394095 about?
NCT00394095 is a clinical study titled "Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine". The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder. The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weig...
What is the current status of trial NCT00394095?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2006-12. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00394095?
The interventions under investigation include: Placebo (DRUG), Topiramate (DRUG).
Who is sponsoring clinical trial NCT00394095?
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 NCT00394095's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 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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