drugset / Trial / NCT02082678

Ondansetron for Bipolar Disorder and Alcohol Use Disorders

NCT02082678

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-02
Primary completion
2018-05
Completion
2018-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ondansetron Other / unclassified 0.5 mg
Comparator Ondansetron Other / unclassified 1 mg
Comparator Ondansetron Other / unclassified 2 mg
Comparator Ondansetron Other / unclassified 4 mg