Nctid:
NCT00001547
Payload:
{"FullStudy"=>{"Rank"=>474139, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000001523", "ConditionMeshTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafAsFound"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M10097", "InterventionBrowseLeafName"=>"Interferons", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M18933", "InterventionBrowseLeafName"=>"Interferon-alpha", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14773", "InterventionBrowseLeafName"=>"Ribavirin", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "EnrollmentInfo"=>{"EnrollmentCount"=>"150"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"June 1996"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"June 2002", "CompletionDateStruct"=>{"CompletionDate"=>"June 2002"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Drug", "Imaging", "Brain", "Metabolism", "Organic Mental Syndrome", "Magnetic Resonance Imaging", "Spectroscopy", "Neuropsychiatric Disorders", "Drug Effects", "Interferon-alpha"]}, "ConditionList"=>{"Condition"=>["Mental Disorder"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"7916159", "ReferenceType"=>"background", "ReferenceCitation"=>"Trzepacz PT. The neuropathogenesis of delirium. A need to focus our research. Psychosomatics. 1994 Jul-Aug;35(4):374-91. doi: 10.1016/S0033-3182(94)71759-X."}, {"ReferencePMID"=>"1632893", "ReferenceType"=>"background", "ReferenceCitation"=>"Dager SR, Steen RG. Applications of magnetic resonance spectroscopy to the investigation of neuropsychiatric disorders. Neuropsychopharmacology. 1992 Jun;6(4):249-66."}, {"ReferencePMID"=>"7972763", "ReferenceType"=>"background", "ReferenceCitation"=>"Ross BD, Jacobson S, Villamil F, Korula J, Kreis R, Ernst T, Shonk T, Moats RA. Subclinical hepatic encephalopathy: proton MR spectroscopic abnormalities. Radiology. 1994 Nov;193(2):457-63. doi: 10.1148/radiology.193.2.7972763."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Use of the drug interferon-alpha (IFN-A), is associated with frequent and well characterized side effects like neurotoxicity. Neurotoxicity can cause symptoms of depression, agitation, anxiety, and/or confusion.\n\nThe NIDDK is conducting a research study called, \"Combination of Alpha Interferon with Long Term Ribavirin Therapy for Patients with Chronic Hepatitis C\" (98-DK-0003). Patients participating in it are receiving interferon-alpha in addition to an antiviral medication called ribavirin. Researchers at the NIMH intend to study patients to learn more about how different medications can influence mood, thoughts and behavior.\n\nThe primary purpose of this study is to determine if treatment with IFN-A in combination with ribavirin alters human brain biochemistry as measured by proton magnetic resonance spectroscopy (MRS).\n\nMRS uses strong magnetic fields in order to measure biochemical products of metabolism found in the brain. Researchers intend to perform MRS scans before, during, and after patients receive their medications\n\nResearchers believe that the combination of IFN-A/Ribavirin will directly affect specific areas of the brain and as a result, some patients will develop specific mood or cognitive symptoms. Patients often must stop taking these medications because of the side effects.\n\nThis study will not contribute directly to the treatment of patient's Hepatitis C condition. However, the information gathered from this study will help researchers better understand the neuropsychiatric affects associated with interferon alpha and ribavirin therapy.", "DetailedDescription"=>"The systemic administration of interferon-alpha (IFN-A) is associated with frequent and well characterized neuropsychiatric toxicity. The primary purpose of this study is to determine if treatment with IFN-A in combination with ribavirin alters human brain biochemistry as measured by proton magnetic resonance spectroscopy. The study population will be drawn from subjects simultaneously enrolled in a NIDDK protocol (98-DK-0003) that employs IFN-A and ribavirin for the treatment of hepatitis C virus (HCV) infection. Subjects will be evaluated prior to IFN-A/ribavirin treatment and then followed prospectively with the specific aim of identifying the emergence of central nervous system (CNS) effects. The principal outcome measures will be as follows: determinations of specific brain metabolites as measured by proton magnetic resonance spectroscopy (1H-MRS), a brief, non-invasive, and minimal risk procedure; ratings of mood, cognitive, and behavioral symptoms.\n\nThe hypotheses being tested in this study are as follows:\n\nTreatment with IFN-A/ribavirin will decrease measures of neuronal integrity (NAA/CRE ratio) in a brain region specific fashion.\nThe degree of change in NAA/CRE in certain brain regions (e.g. prefrontal cortex) will correspond to the development of mood or cognitive symptoms.\n\nThe questions being asked in this study are relevant to the clinical management of HCV patients, since adverse neuropsychiatric effects of IFN-A and ribavirin frequently complicate protocol participation and occasionally result in a subject being taken off protocol. There are no anticipated number of patient days per year required for this study, as all participants will be simultaneously enrolled in NIDDK protocol 98-DK-0003."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Subjects must be at least 18 years of age.\n\nSubjects eligible for this study will be those enrolled in NIDDK protocol 98-DK-0003 and consequently at increased risk for the development of neuropsychiatric toxicity.\n\nSubjects must be able to provide informed consent.\n\nNo individuals who are critically ill or markedly agitated or confused.\n\nNo individuals with implanted cardiac pacemakers or autodefibrillators.\n\nNo individuals with implanted neural pacemakers.\n\nNo individuals with CNS aneurysmal clips.\n\nNo individuals with cochlear implants.\n\nNo individuals with metallic foreign bodies in the eye or CNS.\n\nNo individuals with any form of implanted wire or metal device which may concentrate radiofrequency fields.\n\nNo pregnant women.\n\nNo individuals with a history of moderate to severe claustrophobia."}, "IdentificationModule"=>{"NCTId"=>"NCT00001547", "BriefTitle"=>"Neuropsychiatric Effects of Interferon-Alpha and Ribavirin", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Magnetic Resonance Spectroscopy Study of Neuropsychiatric Effects Associated With Cytokines", "OrgStudyIdInfo"=>{"OrgStudyId"=>"960103"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"96-M-0103"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institute of Mental Health (NIMH)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Mental Health (NIMH)", "LeadSponsorClass"=>"NIH"}}}}}}
