Treatment of Alcohol Dependence and Comorbid Bipolar Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Medical University of South Carolina.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01015586
First received: November 17, 2009
Last updated: July 8, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Alcohol Dependence
Bipolar Disorder
Depression
Mania
Psychosis
Drug: Lamotrigine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial of Lamotrigine In Individuals With Bipolar Disorder and Comorbid Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Percent days of abstinence from alcohol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drinks per week, drinking days per week, heavy drinking days per week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Biomarkers of alcohol use: carbohydrate-deficient transferrin, gamma-glutamyltransferase [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Depression as assessed by scores on the Montgomery-Asberg Depression Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Mania/hypomania symptoms as assessed by the Young Mania Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Neurocognitive performance (California Verbal Learning Test, Rey-Osterrieth Complex Figure Test, etc.) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015586

Contacts
Contact: Bryan K Tolliver, M.D., Ph.D. (843) 792-5215 tollive@musc.edu
Contact: Delisa G Brown (843) 792-0572 browndg@musc.edu

Locations
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    tollive@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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
  More Information

No publications provided

Responsible Party: Bryan K. Tolliver, M.D., Ph.D., Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01015586     History of Changes
Other Study ID Numbers: HR#19550
Study First Received: November 17, 2009
Last Updated: July 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
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
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:
Depression
Depressive Disorder
Bipolar Disorder
Alcoholism
Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Pathologic Processes
Lamotrigine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 19, 2014