Back to resultsOpen-Label Depakote ER in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence
Primary Purpose
Bipolar I or II Depression and Alcohol Abuse or Dependence
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Depakote ER
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar I or II Depression and Alcohol Abuse or Dependence focused on measuring Bipolar I or II, Depression, Alcohol Abuse or Dependence, Mental Health Issues
Eligibility 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
Sites / Locations
- University of Texas Medical Branch
Outcomes
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.
Full Information
NCT ID
NCT00204503
First Posted
September 13, 2005
Last Updated
March 30, 2015
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT00204503
Brief Title
Open-Label Depakote ER in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
5. Study Description
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I or II Depression and Alcohol Abuse or Dependence
Keywords
Bipolar I or II, Depression, Alcohol Abuse or Dependence, Mental Health Issues
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Depakote ER
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Secondary Efficacy Measures for this study are: Percent change in IDS-SR and YMRS from baseline to end of week 16.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stone, M.D.
Organizational Affiliation
University of Texas Medical Branch at Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0188
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Depakote ER in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence
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