drugset / Trial / NCT02082678
Ondansetron for Bipolar Disorder and Alcohol Use Disorders
Phase 4
Completed
70 enrolled
University of Texas Southwestern Medical Center
Stanley Medical Research Institute · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |