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

Phase 4

Withdrawn

• Conditions: Bipolar Disorder

• Registration Number: NCT00221481
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Study Completion: 2006-03
• Status Verified: 2009-02
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

UCLA Neuropsychiatric Institute; 🇺🇸 Los Angeles, California, United States