Bipolar Disorder Clinical Trial
Official title:
An Evaluation of Divalproex vs. Olanzapine for Alcohol Abuse Relapse Prevention in Patients With Bipolar Disorder
This study will evaluate how effective mood stabilizers are in the treatment of bipolar disorder with comorbid alcoholism
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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