Treatment of Alcohol Dependence and Comorbid Bipolar Disorder
Condition: Alcohol Dependence; Bipolar Disorder; Depression; Mania; Psychosis
MeSH terms: Mania; Alcoholism; Depression; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Intervention: Lamotrigine; Placebo
Intervention description: 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
Intervention MeSH terms: Lamotrigine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
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

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.
    

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

               -  Prescribed daily use of first generation antipsychotic agents including
                  chlorpromazine, fluphenazine, or haloperidol or their injectible depot
                  (decanoate) equivalents at a dose adequate to maintain clinical stability as
                  documented by the subject's outpatient psychiatric provider c) Prescribed daily
                  use of second generation antipsychotic agents including olanzapine, risperidone,
                  paliperidone, quetiapine, aripiprazole, or ziprasidone or their injectible depot
                  equivalent at a dose adequate to maintain clinical stability as documented by the
                  subject's outpatient psychiatric provider

          -  Stable psychiatric symptoms as defined by no changes to psychotropic drug regimen for
             30 days

          -  Must agree to identify collateral individuals for contact to facilitate follow-up
             appointments

        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

          -  Concomitant use of benzodiazepines or any other medications not allowed per the
             protocol

          -  Women of childbearing potential who are pregnant, lactating, or refuse adequate forms
             of contraception

          -  Current suicidal or homicidal risk

          -  Baseline scores of more than 35 on the Montgomery-Asberg Depression Rating Scale or
             more than 16 on the Young Mania Rating Scale