Status:
WITHDRAWN
An Evaluation of Divalproex vs. Olanzapine for Alcohol Abuse Relapse Prevention in Patients With Bipolar Disorder
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
University of California, Los Angeles
Conditions:
Bipolar Disorder
Eligibility:
MALE
18-65 years
Phase:
PHASE4
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 togeth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00221481
End Date
March 1 2006
Last Update
June 1 2015
Active Locations (1)
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1
UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90095