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NCT02082678 · ClinicalTrials.gov registry record · Phase 4
Ondansetron for Bipolar Disorder and Alcohol Use Disorders
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT02082678: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT02082678 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 70 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02082678, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study 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.
Primary Outcome
The Hamilton Rating Scale for Depression (HAMD) is a 17-item observer-rated measure of depressive symptomatology. HAMD is scored between 0 and 4 points, with the total score ranging from 0 to 52. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. The higher scores are associated with greater depressive symptom severity and poorer outcome.
Interventions
- DRUG Placebo
- DRUG Ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2014-02 |
| Est. Completion | 2018-05 |
| Phase | Phase 4 |
What the finished NCT02082678 record still lists
NCT02082678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02082678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02082678 about?
NCT02082678 is a clinical study titled "Ondansetron for Bipolar Disorder and Alcohol Use Disorders". 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 featu...
What is the current status of trial NCT02082678?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2014-02. Estimated completion is 2018-05.
What interventions are being tested in trial NCT02082678?
The interventions under investigation include: Placebo (DRUG), Ondansetron (DRUG).
Who is sponsoring clinical trial NCT02082678?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02082678's enrollment target sits among peer trials
70 1043rd of 2000 higher than 931 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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