Treatment of Alcohol Dependence and Comorbid Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01015586
Recruitment Status : Unknown
Verified July 2010 by Medical University of South Carolina.
Recruitment status was:  Recruiting
First Posted : November 18, 2009
Last Update Posted : July 9, 2010
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Bipolar Disorder Depression Mania Psychosis Drug: Lamotrigine Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial of Lamotrigine In Individuals With Bipolar Disorder and Comorbid Alcohol Dependence
Study Start Date : February 2010
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

Arm Intervention/treatment
Experimental: 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
Drug: Lamotrigine
Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks
Other Name: Lamictal

Placebo Comparator: Placebo
Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks
Drug: Placebo
Placebo once daily for 12 weeks

Primary Outcome Measures :
  1. Percent days of abstinence from alcohol [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Drinks per week, drinking days per week, heavy drinking days per week [ Time Frame: 12 weeks ]
  2. Biomarkers of alcohol use: carbohydrate-deficient transferrin, gamma-glutamyltransferase [ Time Frame: 12 weeks ]
  3. Depression as assessed by scores on the Montgomery-Asberg Depression Rating Scale [ Time Frame: 12 weeks ]
  4. Mania/hypomania symptoms as assessed by the Young Mania Rating Scale [ Time Frame: 12 weeks ]
  5. Neurocognitive performance (California Verbal Learning Test, Rey-Osterrieth Complex Figure Test, etc.) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01015586

Contact: Bryan K Tolliver, M.D., Ph.D. (843) 792-5215
Contact: Delisa G Brown (843) 792-0572

United States, South Carolina
Clinical Neuroscience Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Bryan K Tolliver, M.D., Ph.D.    843-792-5215   
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Bryan K Tolliver, MD, PhD Medical University of South Carolina
Study Director: Kathleen T Brady, M.D., Ph.D. Medical University of South Carolina

Responsible Party: Bryan K. Tolliver, M.D., Ph.D., Principal Investigator, Medical University of South Carolina Identifier: NCT01015586     History of Changes
Other Study ID Numbers: HR#19550
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: July 9, 2010
Last Verified: July 2010

Keywords provided by Medical University of South Carolina:
Bipolar Disorder
Manic depression
Cognitive impairment
Executive function
Affective disorder
Carbohydrate deficient transferrin
California Verbal Learning Test
Wisconsin Card Sort Test
Stroop Color and Word Test
Alcohol Stroop Test
Emotion Stroop Test
Point Scoring Reaction Time Test
Rey Osterrieth Complex Figure Test
Trail Making Test
Montgomery Asberg Depression Rating Scale
Young Mania Rating Scale
Timeline Follow Back

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Bipolar and Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers