Alcoholism, Bipolar Disorder
Conditions
Brief summary
The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
Detailed description
The aim of this study is to test the mood stabilizer, anticonvulsant, sodium valproate in individuals with alcohol dependence and bipolar disorder, in a double-blind, placebo-controlled, and randomized trial of 6 months duration. All subjects are treated with treatment as usual, which include lithium carbonate and individual dual recovery counseling and are randomized to either sodium valproate or placebo.
Interventions
DRUGsodium valproate
subjects were randomized to sodium valproate vs placebo. Serum sodium valproate was monitored. This intervention was added on treatment as usual which was defined as being on lithium carbonate and also attending individual dual recovery counseling.
Sponsors
University of Pittsburgh
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meets the criteria for alcohol dependence with comorbid bipolar disorder. * Agreement to participate in outpatient treatment. * Ability to tolerate lithium carbonate and be randomized to receive sodium valproate or placebo. * Stable living situation. * Ability to provide informed consent.
Exclusion criteria
* Psychiatric conditions including schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, unipolar major depression, mental retardation, or signs of impaired cognitive functioning. * Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or focally abnormal electroencephalographic examination. * Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, other impairing or unstable medical condition or impending surgery. * Persistent elevation of liver function enzymes indicating active liver disease. * Pregnancy or not using an acceptable contraceptive method. * Inability to read or understand study forms; agree to informed consent. * Impending incarceration or a mandate to attend treatment by the legal system for an alcohol use disorder. * The presence of either/or cocaine dependence, opioid dependence, and intravenous drug use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in proportion of heavy drinking days | 6 months | Change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in depressive and manic symptoms | 6 months | Changes in depressive and manic symptoms scores from baseline |
Countries
United States
Outcome results
None listed