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NCT01566370 · ClinicalTrials.gov registry record · Phase 2
Zonisamide for Heavy Drinkers With Bipolar Disorder
A Phase 2 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01566370: Clinical Trial Phase 2 study, sponsored by Yale University.
NCT01566370 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01566370, a Phase 2 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a randomized, double blind, placebo controlled trial of the medication zonisamide for the purpose of reducing heavy drinking and drinking, as well as reducing mood symptoms, in bipolar subjects that drink excessively and heavily. Hypotheses: (Primary aims); Add-on zonisamide compared to placebo will result in: 1. significant reduction in heavy drinking days, drinks per week and per drinking day, and significantly greater increase in abstinent days, ii) greater rates of abstinence and abstinence to heavy drinking, greater reduction in biomarkers of heavy alcohol use such as gamma-glutamyl transferase (GGT), and greater reduction in alcohol urge or "craving", 2. Significant reduction in prevalent mood symptoms on the BRMS and BRMeS, CARS, HAMD, or no worsening of euthymic mood, and significant improvement on the Clinical Global Impressions Scale-Severity. 3. (Secondary aims) Add-on zonisamide compared to placebo will result in significant reduction in weight (kilograms) and other secondary weight-related metabolic factors such as fasting glucose, lipid profile, and blood pressure. 4. (Secondary aims) Add-on zonisamide compared to placebo will result in improved clinical global impression, overall functioning, quality of life, and reduced medical symptoms. 5.) (Exploratory Aims) To will examine interactions between genotype and medication on treatment response for allelic variation in genetic loci related to the major neurotransmitter and neurophysiologic pathways that are relevant to bipolar disorder, alcoholism, and zonisamide mechanism of action.
Primary Outcome
The percentage of total heavy drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), totaled between the time-points of weeks 11 and 14 (4 weeks time frame).
Interventions
- DRUG Placebo
- DRUG Zonisamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
Why NCT01566370 stopped before completion
NCT01566370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01566370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01566370 about?
NCT01566370 is a clinical study titled "Zonisamide for Heavy Drinkers With Bipolar Disorder". This is a randomized, double blind, placebo controlled trial of the medication zonisamide for the purpose of reducing heavy drinking and drinking, as well as reducing mood symptoms, in bipolar subjects that drink excessively and heavily. Hypotheses: (Primary aims); Add-on zonisamide compared to pla...
What is the current status of trial NCT01566370?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2012-05. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01566370?
The interventions under investigation include: Placebo (DRUG), Zonisamide (DRUG).
Who is sponsoring clinical trial NCT01566370?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01566370's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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