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

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 2

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

Treatments: Drug: Depakote ER

Study type: Interventional

Funder types: Other

Identifiers

NCT00204503

FRS 467640

03-048

Details and patient eligibility

About

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.

Full 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. Although there are available treatments for bipolar depression, no studies have been done to evaluate efficacy in bipolar patients with comorbid substance abuse disorders. Given the independent open-label evidence for efficacy and safety of divalproex sodium in alcohol abuse and bipolar depression, divalproex sodium is the most likely candidate for potential success in bipolar depressed patients with comorbid alcohol abuse or dependence. 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)