Conditions: Alcohol Dependence Bipolar Disorder Depression Mania Psychosis
Keywords: Alcohol Bipolar Disorder Manic depression Addiction Alcoholism Cognitive impairment Executive function Anxiety Depression Mania Affective disorder Psychosis Carbohydrate deficient transferrin Gammaglutamyltransferase California Verbal Learning Test Montgomery Asberg Depression Rating Scale Young Mania Rating Scale Timeline Follow Back
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Add-on lamotrigine plus pre-existing mood stabilizing medication regimen. Active fixed-dose drug titration from 25-200 mg/day over first six weeks, 200 mg/day fixed-dose maintenance for second six weeks arm 2: Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks

Interventions: intervention 1: Lamotrigine intervention 2: Placebo
Intervention descriptions: intervention 1: Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks intervention 2: Placebo once daily for 12 weeks

Protocol document: