Clinical trial NCT00000439: Drug Treatment for Alcoholics With Bipolar Disorder
Official title: Efficacy of Valproate Maintenance in Bipolar Alcoholics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Bipolar Disorder
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
Collaborators: name: University of Pittsburgh
First posted: 1999-11-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in proportion of heavy drinking days
timeFrame: 6 months
Secondary outcomes:
measure: Changes in depressive and manic symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Miami
name: Ihsan M Salloum, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.