Text Size

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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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.


Condition Intervention Phase
Bipolar I or II Depression and Alcohol Abuse or Dependence
 Drug: Depakote ER
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Secondary Efficacy Measures for this study are: Percent change in IDS-SR and YMRS from baseline to end of week 16.

Estimated Enrollment: 30
Study Start Date: June 2003
Estimated Study Completion Date: May 2005
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. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204503

Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0188
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Michael Stone, M.D. University of Texas Medical Branch at Galveston
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00204503     History of Changes
Other Study ID Numbers: 03-048, FRS 467640
Study First Received: September 13, 2005
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas, Galveston:
Bipolar I or II
Depression
Alcohol Abuse or Dependence
Mental Health Issues

Additional relevant MeSH terms:
Depression
Depressive Disorder
Alcoholism
Behavioral Symptoms
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013