Open-Label Depakote ER in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence

Withdrawn before enrolling · Phase 2

Conditions studied: Bipolar I or II Depression and Alcohol Abuse or Dependence

In brief

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.

Key facts

Study ID

NCT00204503

Run by

The University of Texas Medical Branch, Galveston

People needed

0

Starts

2003-06-01

Expected to finish

2005-05-01

Last updated by the study team

2015-03-31

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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