A Double-Blind, Placebo-Controlled Trial of Lamotrigine In Individuals With Bipolar Disorder and Comorbid Alcohol Dependence
Overview
- Phase
- Phase 4
- Intervention
- Lamotrigine
- Conditions
- Alcohol Dependence
- Sponsor
- Medical University of South Carolina
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Percent Days Abstinent From Alcohol
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-65
- •Meet DSM-IV-TR criteria for current alcohol dependence with active alcohol use in the past 30 days
- •Meet DSM-IV-TR criteria for bipolar I or bipolar II disorder
- •Have average alcohol consumption of at least 35 drinks/week for men, 28 drinks/week for women in the last 4 weeks of active drinking prior to enrollment.
- •Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
- •Must consent to random assignment and be willing to commit to medication treatment and follow-up assessments.
- •Currently under the care of a psychiatrist.
- •Must consent to sign a release of information allowing investigators to communicate with his/her psychiatrist to verify treatment history and facilitate care should treatment-emergent psychiatric symptoms develop during the trial.
- •Currently taking a therapeutic dosage of one or more mood stabilizing medications as defined by one or more of the following:
- •Lithium level of 0.6 - 1.2 mEq/L
Exclusion Criteria
- •A primary psychiatric diagnosis other than bipolar disorder
- •Any uncontrolled neurologic condition (e.g. epilepsy) that could confound the results of the study
- •Any history of Stevens-Johnson syndrome or other severe rash requiring hospitalization
- •Any history of head injury with loss of consciousness greater than 30 minutes
- •Any history of learning disability, alcoholic dementia, or electroconvulsive therapy in the past 3 months
- •Any uncontrolled medical condition that may adversely affect the conduct of the trial or jeopardize the safety of the subject
- •Plasma levels of liver transaminases (AST, ALT) greater than 3 times the normal range
- •Concomitant use of valproic acid
- •Concomitant use of carbamazepine, oxcarbazepine, phenytoin, primidone, or phenobarbital
- •Concomitant use of disulfiram, naltrexone, acamprosate, or topiramate
Arms & Interventions
Lamotrigine
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
Intervention: Lamotrigine
Placebo
Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Percent Days Abstinent From Alcohol
Time Frame: 12 weeks
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.
Secondary Outcomes
- Percent Heavy Drinking Days(12 weeks)
- Biomarkers of Alcohol Use: Carbohydrate-deficient Transferrin (CDT)(12 weeks after randomization)
- Biomarkers of Alcohol Use: Gamma-glutamyltransferase (GGT)(12 weeks after randomization)
- Montgomery-Asberg Depression Rating Scale (MADRS) Score(Baseline and 12 weeks)
- Young Mania Rating Scale (YMRS) Scores(Baseline and 12 weeks)
- Neurocognitive Performance (California Verbal Learning Test)(Study endpoint 12 weeks after randomization)