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Trial NCT00000439

Resource URI: http://static.linkedct.org/resource/trials/NCT00000439
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/60260>
linkedct:brief_title Drug Treatment for Alcoholics With Bipolar Disorder
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8843>
linkedct:condition <http://static.linkedct.org/resource/condition/1630>
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct: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.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 65 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date August 2003
linkedct:enrollment 72 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:has_dmc No
linkedct:id NCT00000439
linkedct:intervention <http://static.linkedct.org/resource/intervention/112118>
rdfs:label Trial NCT00000439
linkedct:lastchanged_date February 24, 2009
linkedct:lead_sponsor_agency National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:location <http://static.linkedct.org/resource/location/157763>
linkedct:nct_id NCT00000439
linkedct:number_of_arms 1 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Efficacy of Valproate Maintenance in Bipolar Alcoholics
linkedct:org_study_id NIAAASAL10523
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/23590>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000439>
linkedct:phase Phase 2
linkedct:primary_completion_date August 2003
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/46747>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/4360>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/25160>
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:start_date October 2000
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date February 2009