CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 54 enrolled
Drug / intervention
Exenatide +1 moredrug
Likely dose
Exenatide 5 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00845507
NCT00845507Phase 4Completed

A Double-Blind Placebo-Controlled Study of Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults With Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder

University of Cincinnati·interventional·Posted Feb 18, 2009·Updated Apr 20, 2018

In Brief

A Phase 4 clinical trial evaluating Exenatide and Placebo for Weight Gain. Completed, enrolled 54 participants across 1 site.

Detailed Summary

The purpose of this research study is to test the safety and efficacy (how well it works) of exenatide as a treatment for weight gain associated with olanzapine in obese adults with Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder Exenatide has been approved by the FDA for the treatment of Type 2 diabetes. It has not been approved for the treatment of weight gain associated with olanzapine in obese adults with bipolar disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWeight Gain
CountriesUnited States

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 18, 2009
Enrollment StartDec 1, 2008
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 17.4 years ago

Interventions

Exenatidedrug

The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.

Placebodrug

Placebo: Sterile solution in equivalent doses as Exenatide