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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00204503
First received: September 13, 2005
Last updated: April 13, 2011
Last verified: April 2011

September 13, 2005
April 13, 2011
June 2003
Not Provided
Primary Efficacy Measures for this study are: Percent change in MADRS from baseline score to study endpoint; Percent of days heavy drinking from 120 days prescreen to study end point; and Percent of subjects successfully completing outpatient detox.
Same as current
Complete list of historical versions of study NCT00204503 on ClinicalTrials.gov Archive Site
Secondary Efficacy Measures for this study are: Percent change in IDS-SR and YMRS from baseline to end of week 16.
Same as current
Not Provided
Not Provided
 
Open-Label Depakote ER in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence
An Open Label Pilot Study Evaluating Safety and Efficacy of Divalproex Sodium (Depakote ER) in Patients With Bipolar I or II Depression and 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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar I or II Depression and Alcohol Abuse or Dependence
Drug: Depakote ER
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
30
May 2005
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00204503
03-048, FRS 467640
Not Provided
Not Provided
The University of Texas, Galveston
Not Provided
Principal Investigator: Michael Stone, M.D. University of Texas Medical Branch at Galveston
The University of Texas, Galveston
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP