Bipolar I or II Depression and Alcohol Abuse or Dependence
Conditions
Keywords
Bipolar I or II, Depression, Alcohol Abuse or Dependence, Mental Health Issues
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.
Interventions
DRUGDepakote ER
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary Efficacy Measures for this study are: Percent change in IDS-SR and YMRS from baseline to end of week 16. | — |
Countries
United States
Outcome results
None listed