CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Ondansetron +1 moredrug
Likely dose
Not stated in 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/NCT02082678
NCT02082678Phase 4Completed
CompareCT.gov

Ondansetron for Bipolar Disorder and Alcohol Use Disorders

University of Texas Southwestern Medical Center·interventional·Posted Mar 10, 2014·Updated Aug 24, 2021

In Brief

A Phase 4 clinical trial evaluating Ondansetron and Placebo for Bipolar Disorder and 2 related conditions. Completed, enrolled 70 participants across 1 site.

Detailed Summary

The purpose of the study is to determine if ondansetron, as an add-on therapy, is associated with reduced depressive symptoms and alcohol use in outpatients with bipolar disorder (BPD), cyclothymic disorder, schizoaffective disorder (bipolar type) and major depressive disorder (MDD) with mixed features. The investigators will also use blood samples to determine if the genotype for the serotonin transporter gene is associated with response to ondansetron.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Alcohol Use Disorder, Dual Diagnosis
CountriesUnited States
CollaboratorsStanley Medical Research Institute

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 10, 2014
Enrollment StartFeb 1, 2014
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.3 years ago

Interventions

Ondansetrondrug

Ondansetron is a serotonin receptor antagonist that is FDA-approved to treat nausea and vomiting caused by cancer therapy and surgery.

Placebodrug

Inactive ingredient matching the active medication in appearance