An Evaluation of Divalproex vs. Olanzapine for Alcohol Abuse Relapse Prevention in Patients With Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00221481
First received: September 13, 2005
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

This study will evaluate how effective mood stabilizers are in the treatment of bipolar disorder with comorbid alcoholism


Condition Intervention Phase
Bipolar Disorder
Drug: divalproex or olanzapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: An Evaluation of Divalproex vs. Olanzapine for Alcohol Abuse Relapse Prevention in Patients With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Estimated Study Completion Date: March 2006
Detailed Description:

Bipolar affective disorder is a medical illness with substantial morbidity and mortality. Further fueling the severity of this illness is the substantial co-occurrence with substance abuse that together poses an enormous public health problem.

This study will evaluate the efficacy of divaproex sodium (DVPX) vs. olanzapine (ZYP) vs. for alcohol relapse prevention and secondary mood stabilization. Bipolar patients who are actively drinking will be randomized to either Depakote ER ® (flexible dose schedule up to 2500 mg) or Zyprexa® (flexible dose schedule up to 20 mg). Adjunctive benzodiazepine will be utilized for the treatment of alcohol withdrawal and as an adjunct anxiolytic during the early titration of DVPX and ZYP. Patients who, after 2 weeks, have stabilized will continue in the prophylaxis study which will last up to 46 weeks. Flexible dose scheduling and adjunctive antidepressant treatment as clinically indicated will be done to maximize tolerability, treatment compliance, and mood stability.

The primary outcome measure will be alcohol abuse relapse which will be defined, a priori, as 5 drinks in a 24 hour period. Patients who have a relapse as such defined will be terminated from the study. Secondary alcohol outcome measures (i.e. number of drinking days, % drinking days per month, standard drinks per drinking occasion, craving) will be assessed through the time-line follow-back method. Secondary outcome measures of mood stabilization (major mood relapse and adjunctive medication) will be assessed by prospective life charting.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65
  • DSM-IV criteria for manic episode based on the SCID (Spitzer 1996)
  • DSM-IV criteria for alcohol dependence or abuse based on the SCID. Meeting criteria for polysubstance dependence or abuse will not be exclusionary.
  • Alcohol dependence/abuse confirmed by corroboration.
  • Negative urine pregnancy test l

Exclusion Criteria:

  • Inability to give informed consent
  • Liver function tests greater than 3X the upper limit of normal
  • History of adverse reaction to divalproex sodium or olanzapine
  • History of seizure other than directly associated with prior alcohol withdrawal
  • History of major head trauma with LOC > 5 minutes or skull fracture
  • History of hypertension, neurologic illness
  • Active hepatitis, hepatic encephalopathy, or history of pancreatitis
  • Not practicing a reliable form of birth control
  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: NCT00221481

Locations
United States, California
UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Mark A Frye, MD University of California, Los Angeles
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00221481     History of Changes
Other Study ID Numbers: IRB 00-12-071-11A
Study First Received: September 13, 2005
Last Updated: February 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Bipolar
Alcohol

Additional relevant MeSH terms:
Bipolar Disorder
Alcoholism
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Valproic Acid
Olanzapine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014