Drug Treatment for Alcoholics With Bipolar Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Valproate Maintenance in Bipolar Alcoholics

Conditions
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Alcoholism, Bipolar Disorder

Intervention / Treatment
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* Drug: sodium valproate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sodium valproate<br>sodium valproate was added on treatment as usual and dose monitored by blood level measurements | Drug: sodium valproate<br>* 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.<br>* Other names: Depakote, Divalproex sodium, Depacon;|
| Placebo Comparator: placebo<br>Placebo comparator was added on treatment as usual and dose monitored by blood level measurements | Drug: sodium valproate<br>* 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.<br>* Other names: Depakote, Divalproex sodium, Depacon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proportion of heavy drinking days | Change from baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depressive and manic symptoms | Changes in depressive and manic symptoms scores from baseline | 6 months |