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Treatment of Alcohol Dependence and Comorbid Bipolar Disorder

NCT01015586 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-01-09

Study results available
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Summary

The study will determine if individuals with co-occurring bipolar disorder and alcohol dependence report reduced alcohol consumption, improvement in mood symptoms, and cognitive performance if treated with lamotrigine plus their usual mood stabilizing medications relative to subjects treated with placebo plus usual mood stabilizing medications over a 16 week period.

Conditions

Interventions

DRUG

Lamotrigine

Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks

DRUG

Placebo

Placebo once daily for 12 weeks

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Bryan K Tolliver, MD, PhD · Medical University of South Carolina

  • Kathleen T Brady, M.D., Ph.D. · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-05-31
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015586 on ClinicalTrials.gov