Clinical trial NCT01015586: Treatment of Alcohol Dependence and Comorbid Bipolar Disorder
Official title: A Double-Blind, Placebo-Controlled Trial of Lamotrigine In Individuals With Bipolar Disorder and Comorbid Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2009-11-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Days Abstinent From Alcohol
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent Heavy Drinking Days
timeFrame: 12 weeks
measure: Biomarkers of Alcohol Use: Carbohydrate-deficient Transferrin (CDT)
timeFrame: 12 weeks after randomization
measure: Biomarkers of Alcohol Use: Gamma-glutamyltransferase (GGT)
timeFrame: 12 weeks after randomization
measure: Montgomery-Asberg Depression Rating Scale (MADRS) Score
timeFrame: Baseline and 12 weeks
measure: Young Mania Rating Scale (YMRS) Scores
timeFrame: Baseline and 12 weeks
measure: Neurocognitive Performance (California Verbal Learning Test)
timeFrame: Study endpoint 12 weeks after randomization
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Clinical Neuroscience Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Bryan K Tolliver, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Kathleen T Brady, M.D., Ph.D.
role: STUDY_DIRECTOR
References: