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

• Status: Withdrawn
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: University of California, Los Angeles
• Treatments: Ethanol; Olanzapine; Valproic Acid

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