Bipolar I or II Depression and Alcohol Abuse or Dependence Clinical Trial
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.
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | May 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Texas Medical Branch | Galveston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Texas Medical Branch, Galveston |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Secondary Efficacy Measures for this study are: Percent change in IDS-SR and YMRS from baseline to end of week 16. |