NCT01015586

Treatment of Alcohol Dependence and Comorbid Bipolar Disorder

A Double-Blind, Placebo-Controlled Trial of Lamotrigine In Individuals With Bipolar Disorder and Comorbid Alcohol Dependence

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Alcohol Dependence
• Bipolar Disorder
• Depression
• Mania
• Psychosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-05-01
• Completion: 2014-09-01
• First posted: 2009-11-18
• Last updated: 2019-01-09
• Results posted: 2019-01-09

Locations

1 site across 1 country: United States