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

Withdrawn before enrolling · Phase 4

Conditions studied: Bipolar Disorder

In brief

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

Key facts

Study ID

NCT00221481

Run by

Mayo Clinic

People needed

0

Expected to finish

2006-03-01

Last updated by the study team

2015-06-01

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Neuropsychiatric Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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