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Trial record 5 of 69 for:    "Bipolar Disorder" | "Olanzapine"

An Evaluation of Divalproex vs. Olanzapine for Alcohol Abuse Relapse Prevention in Patients With 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: NCT00221481
Recruitment Status : Withdrawn (Lack of recruitment)
First Posted : September 22, 2005
Last Update Posted : June 1, 2015
University of California, Los Angeles
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: divalproex or olanzapine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: An Evaluation of Divalproex vs. Olanzapine for Alcohol Abuse Relapse Prevention in Patients With Bipolar Disorder
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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:   Male
Accepts Healthy Volunteers:   No

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

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): NCT00221481

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United States, California
UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Mayo Clinic
University of California, Los Angeles
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Principal Investigator: Mark A Frye, MD University of California, Los Angeles

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Responsible Party: Mark Frye, Principal Investigator, Mayo Clinic Identifier: NCT00221481     History of Changes
Other Study ID Numbers: IRB 00-12-071-11A
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: February 2009
Keywords provided by Mark Frye, Mayo Clinic:
Additional relevant MeSH terms:
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Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental 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
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents