Bipolar Disorder Clinical Trial
Official title:
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 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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