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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks
Placebo once daily for 12 weeks
Clinical Neuroscience Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Charleston, South Carolina, United States
Percent Days Abstinent From Alcohol
Percentage of days in trial without consumption of alcoholic beverages per participant self-report; minimum = 0, maximum = 100; higher numbers indicate better outcome. Percent days abstinent was calculated as: (number of days abstinent per self-report / total number of days in trial)\*100.
Time frame: 12 weeks
Percent Heavy Drinking Days
Percentage of days in trial that were heavy drinking days (5 or more drinks/day for men, 4 or more drinks/day for women); minimum = 0, maximum = 100; lower numbers indicate better outcome. Percent heavy drinking days was calculated as: (number of days of heavy drinking per self-report / total number of days in trial)\*100.
Time frame: 12 weeks
Biomarkers of Alcohol Use: Carbohydrate-deficient Transferrin (CDT)
Serum levels of biomarkers of alcohol use: carbohydrate-deficient transferrin (CDT) at study endpoint in study completers
Time frame: 12 weeks after randomization
Biomarkers of Alcohol Use: Gamma-glutamyltransferase (GGT)
Serum levels of biomarkers of alcohol use: Gamma-glutamyltransferase (GGT) at study endpoint in study completers
Time frame: 12 weeks after randomization
Montgomery-Asberg Depression Rating Scale (MADRS) Score
Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) at baseline (all randomized subjects) and at study endpoint (study completers). Scores represent total summed score of ten (10) subscale items; minimum = 0, maximum = 60, higher scores indicate worse outcomes.
Time frame: Baseline and 12 weeks
Young Mania Rating Scale (YMRS) Scores
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Mania/hypomania symptoms at study endpoint as assessed by the Young Mania Rating Scale (YMRS) at baseline (all randomized subjects) and at study endpoint (study completers). Scores represent total summed score of eleven (11) subscale items; minimum = 0, maximum = 60, higher scores indicate worse outcomes.
Time frame: Baseline and 12 weeks
Neurocognitive Performance (California Verbal Learning Test)
Adjusted scale scores (T scores) on the California Verbal Learning Test (CVLT) of verbal working memory at study endpoint. CVLT Trials 1-5 Free Recall Total measures the sum of all word list items correctly recalled on learning trials 1 through 5. This raw score is converted to a T-score (mean = 50; SD=10) with higher scores indicating better performance.
Time frame: Study endpoint 12 weeks after randomization