Nctid:
NCT00000439
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000437", "term"=>"Alcoholism"}, {"id"=>"D000001714", "term"=>"Bipolar Disorder"}], "ancestors"=>[{"id"=>"D000068105", "term"=>"Bipolar and Related Disorders"}, {"id"=>"D000019964", "term"=>"Mood Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000019973", "term"=>"Alcohol-Related Disorders"}, {"id"=>"D000019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D000064419", "term"=>"Chemically-Induced Disorders"}], "browseLeaves"=>[{"id"=>"M4996", "name"=>"Bipolar Disorder", "asFound"=>"Bipolar Disorder", "relevance"=>"HIGH"}, {"id"=>"M3783", "name"=>"Alcoholism", "asFound"=>"Alcoholism", "relevance"=>"HIGH"}, {"id"=>"M226", "name"=>"Bipolar and Related Disorders", "relevance"=>"LOW"}, {"id"=>"M21835", "name"=>"Mood Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M21842", "name"=>"Alcohol-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000014635", "term"=>"Valproic Acid"}], "ancestors"=>[{"id"=>"D000000927", "term"=>"Anticonvulsants"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000018682", "term"=>"GABA Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018692", "term"=>"Antimanic Agents"}, {"id"=>"D000014149", "term"=>"Tranquilizing Agents"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000011619", "term"=>"Psychotropic Drugs"}], "browseLeaves"=>[{"id"=>"M19022", "name"=>"Lithium Carbonate", "relevance"=>"LOW"}, {"id"=>"M17383", "name"=>"Valproic Acid", "asFound"=>"10-14", "relevance"=>"HIGH"}, {"id"=>"M4246", "name"=>"Anticonvulsants", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anticonvulsants", "abbrev"=>"AntiConv"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>72}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2000-10"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2018-01", "completionDateStruct"=>{"date"=>"2003-08", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2018-01-16", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2018-01-18", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2003-08", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change in proportion of heavy drinking days", "timeFrame"=>"6 months", "description"=>"Change from baseline"}], "secondaryOutcomes"=>[{"measure"=>"Changes in depressive and manic symptoms", "timeFrame"=>"6 months", "description"=>"Changes in depressive and manic symptoms scores from baseline"}]}, "oversightModule"=>{"oversightHasDmc"=>false}, "conditionsModule"=>{"conditions"=>["Alcoholism", "Bipolar Disorder"]}, "referencesModule"=>{"references"=>[{"pmid"=>"15630071", "type"=>"RESULT", "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."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.", "detailedDescription"=>"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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Meets the criteria for alcohol dependence with comorbid bipolar disorder.\n* Agreement to participate in outpatient treatment.\n* Ability to tolerate lithium carbonate and be randomized to receive sodium valproate or placebo.\n* Stable living situation.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Psychiatric conditions including schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, unipolar major depression, mental retardation, or signs of impaired cognitive functioning.\n* Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or focally abnormal electroencephalographic examination.\n* Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, other impairing or unstable medical condition or impending surgery.\n* Persistent elevation of liver function enzymes indicating active liver disease.\n* Pregnancy or not using an acceptable contraceptive method.\n* Inability to read or understand study forms; agree to informed consent.\n* Impending incarceration or a mandate to attend treatment by the legal system for an alcohol use disorder.\n* The presence of either/or cocaine dependence, opioid dependence, and intravenous drug use."}, "identificationModule"=>{"nctId"=>"NCT00000439", "briefTitle"=>"Drug Treatment for Alcoholics With Bipolar Disorder", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)"}, "officialTitle"=>"Efficacy of Valproate Maintenance in Bipolar Alcoholics", "orgStudyIdInfo"=>{"id"=>"NIAAASAL10523"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"sodium valproate", "description"=>"sodium valproate was added on treatment as usual and dose monitored by blood level measurements", "interventionNames"=>["Drug: sodium valproate"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"placebo", "description"=>"Placebo comparator was added on treatment as usual and dose monitored by blood level measurements", "interventionNames"=>["Drug: sodium valproate"]}], "interventions"=>[{"name"=>"sodium valproate", "type"=>"DRUG", "otherNames"=>["Depakote, Divalproex sodium, Depacon"], "description"=>"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.", "armGroupLabels"=>["placebo", "sodium valproate"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"15213", "city"=>"Pittsburgh", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center", "geoPoint"=>{"lat"=>40.44062, "lon"=>-79.99589}}], "overallOfficials"=>[{"name"=>"Ihsan M Salloum, MD, MPH", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Miami"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"University of Pittsburgh", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
