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Treatment of Alcohol Dependence and Comorbid Bipolar Disorder

Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Dependence; Bipolar Disorder; Depression; Mania; Psychosis

Intervention: Lamotrigine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Medical University of South Carolina

Official(s) and/or principal investigator(s):
Bryan K Tolliver, MD, PhD, Principal Investigator, Affiliation: Medical University of South Carolina
Kathleen T Brady, M.D., Ph.D., Study Director, Affiliation: Medical University of South Carolina

Overall contact:
Bryan K Tolliver, M.D., Ph.D., Phone: (843) 792-5215, Email: tollive@musc.edu


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.

Clinical Details

Official title: A Double-Blind, Placebo-Controlled Trial of Lamotrigine In Individuals With Bipolar Disorder and Comorbid Alcohol Dependence

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percent days of abstinence from alcohol

Secondary outcome:

Drinks per week, drinking days per week, heavy drinking days per week

Biomarkers of alcohol use: carbohydrate-deficient transferrin, gamma-glutamyltransferase

Depression as assessed by scores on the Montgomery-Asberg Depression Rating Scale

Mania/hypomania symptoms as assessed by the Young Mania Rating Scale

Neurocognitive performance (California Verbal Learning Test, Rey-Osterrieth Complex Figure Test, etc.)


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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


- Concomitant use of disulfiram, naltrexone, acamprosate, or topiramate

- Concomitant use of benzodiazepines or any other medications not allowed per the


- 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

Locations and Contacts

Bryan K Tolliver, M.D., Ph.D., Phone: (843) 792-5215, Email: tollive@musc.edu

Clinical Neuroscience Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Bryan K Tolliver, M.D., Ph.D., Phone: 843-792-5215, Email: tollive@musc.edu
Additional Information

Starting date: February 2010
Last updated: July 8, 2010

Page last updated: August 23, 2015

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