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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
| Completed |
NCT02855762 -
Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder
|
N/A | |
| Recruiting |
NCT05915013 -
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
|
Phase 1 | |
| Recruiting |
NCT05206747 -
Ottawa Sunglasses at Night for Mania Study
|
N/A | |
| Completed |
NCT02513654 -
Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
|
Phase 1 | |
| Recruiting |
NCT06313918 -
Exercise Therapy in Mental Disorders-study
|
N/A | |
| Completed |
NCT02304432 -
Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine
|
Early Phase 1 | |
| Recruiting |
NCT06197048 -
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
|
N/A | |
| Completed |
NCT03497663 -
VIA Family - Family Based Early Intervention Versus Treatment as Usual
|
N/A | |
| Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
| Completed |
NCT02212041 -
Electronic Cigarettes in Smokers With Mental Illness
|
N/A | |
| Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
| Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
| Active, not recruiting |
NCT03641300 -
Efficacy of Convulsive Therapies for Bipolar Depression
|
N/A | |
| Not yet recruiting |
NCT04432116 -
Time and Virtual Reality in Schizophrenia and Bipolar Disorder
|
N/A | |
| Completed |
NCT02970721 -
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
|
||
| Terminated |
NCT02893371 -
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
|
||
| Terminated |
NCT02909504 -
Gao NARASD Lithium Study
|
Phase 4 | |
| Recruiting |
NCT03088657 -
Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
|
||
| Recruiting |
NCT02481245 -
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
|
Phase 2 |