Status:
WITHDRAWN
Open-Label Depakote ER in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Bipolar I or II Depression and Alcohol Abuse or Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if Divalproex Sodium can be used to Treat and Prevent Depression in Patients with Bipolar Disorder who have Comorbid Alcohol Dependence/Abuse.
Detailed Description
Over half of all patients with bipolar disorder have comorbid substance abuse. The most common substance of abuse is alcohol, which is most commonly associated with the depressed phase of the illness....
Eligibility Criteria
Inclusion
- MADRS \>= 20 at screen and 18 at baseline
- YMRS =\< 11 at screen and baseline
- DMS-IV criteria for past manic or hypomanic episode based on the SCID
- DSM-VI criteria for alcohol dependence or abuse based on the SCID.
- Alcohol dependence/abuse confirmed by corroboration from family member
- Negative urine pregnancy test
Exclusion
- Inability to give informed consent
- Inability to give reliable assessment of alcohol consumption
- Evidence of alcohol consumption one week prior to baseline
- Liver function tests greater than 3X upper limit of normal at screen
- History of active hepatitis or hepatic encephalopathy
- History of pancreatitis
- History of adverse reaction to divalproex sodium
- History of seizure other than directly associated w/prior alcohol withdrawl
- History of major head trauma with LOC \> 10 min. or skull fracture
- Hisotry of hypertension or neurologic illness
- If female, not practicing an effective form of birth control
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00204503
Start Date
June 1 2003
End Date
May 1 2005
Last Update
March 31 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0188