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

NCT00221481 | Withdrawn Phase 4

• 1 other identifier: IRB 00-12-071-11A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar Disorder

Keywords

Bipolar; Alcohol

Interventions

divalproex or olanzapine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• DSM-IV criteria for manic episode based on the SCID (Spitzer 1996)
• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

UCLA Neuropsychiatric Institute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic Acid; Olanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mark A Frye, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Completion: March 1, 2006
• Last Updated: June 1, 2015

Record last verified: 2009-02

Locations

US (1)