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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 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 31 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Topiramate

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2006-12
Est. Completion 2009-09
Phase Phase 4

Sponsor

University of Cincinnati

245 total trials

What the Registry Record Tells You About NCT00394095

The ClinicalTrials.gov registry entry for NCT00394095 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Cincinnati, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00394095 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.