NCT01566370

Zonisamide for Heavy Drinkers With Bipolar Disorder

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Use Disorders
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Zonisamide	titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose
DRUG	Placebo	placebo

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-03-29
• Last updated: 2017-01-13
• Results posted: 2016-04-22

Locations

1 site across 1 country: United States