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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sodium valproate | Active Comparator | sodium valproate was added on treatment as usual and dose monitored by blood level measurements |
|
| placebo | Placebo Comparator | Placebo comparator was added on treatment as usual and dose monitored by blood level measurements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium valproate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in proportion of heavy drinking days | Change from baseline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in depressive and manic symptoms | Changes in depressive and manic symptoms scores from baseline | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ihsan M Salloum, MD, MPH | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15630071 | Result | Salloum IM, Cornelius JR, Daley DC, Kirisci L, Himmelhoch JM, Thase ME. Efficacy of valproate maintenance in patients with bipolar disorder and alcoholism: a double-blind placebo-controlled study. Arch Gen Psychiatry. 2005 Jan;62(1):37-45. doi: 10.1001/archpsyc.62.1.37. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |