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NCT00203450 · ClinicalTrials.gov registry record · Phase 4
Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial
A Phase 4 study, sponsored by Tuscaloosa Research & Education Advancement Corporation.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT00203450: Completed Phase 4 study, sponsored by Tuscaloosa Research & Education Advancement Corporation.
NCT00203450 is a Phase 4 study that has completed, run by Tuscaloosa Research & Education Advancement Corporation. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00203450, a Phase 4 study, has completed, sponsored by Tuscaloosa Research & Education Advancement Corporation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index (BMI) of \>25 and are on a psychotropic medication with a known side effect of weight gain.
Interventions
- DRUG Placebo
- DRUG Zonegran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2003-05 |
| Est. Completion | 2006-03 |
| Phase | Phase 4 |
What the finished NCT00203450 record still lists
NCT00203450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00203450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00203450 about?
NCT00203450 is a clinical study titled "Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial". The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index (BMI) of \>25 and are on a psychotropic medication with a known side effect of weight gain.
What is the current status of trial NCT00203450?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2003-05. Estimated completion is 2006-03.
What interventions are being tested in trial NCT00203450?
The interventions under investigation include: Placebo (DRUG), Zonegran (DRUG).
Who is sponsoring clinical trial NCT00203450?
This trial is sponsored by Tuscaloosa Research & Education Advancement Corporation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00203450's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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