Nctid:
NCT00001771
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D005879", "term"=>"Tourette Syndrome"}, {"id"=>"D012559", "term"=>"Schizophrenia"}, {"id"=>"D003193", "term"=>"Compulsive Personality Disorder"}, {"id"=>"D009771", "term"=>"Obsessive-Compulsive Disorder"}, {"id"=>"D001523", "term"=>"Mental Disorders"}], "ancestors"=>[{"id"=>"D019967", "term"=>"Schizophrenia Spectrum and Other Psychotic Disorders"}, {"id"=>"D010554", "term"=>"Personality Disorders"}, {"id"=>"D001008", "term"=>"Anxiety Disorders"}, {"id"=>"D001480", "term"=>"Basal Ganglia Diseases"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D013981", "term"=>"Tic Disorders"}, {"id"=>"D009069", "term"=>"Movement Disorders"}, {"id"=>"D020271", "term"=>"Heredodegenerative Disorders, Nervous System"}, {"id"=>"D019636", "term"=>"Neurodegenerative Diseases"}, {"id"=>"D030342", "term"=>"Genetic Diseases, Inborn"}, {"id"=>"D065886", "term"=>"Neurodevelopmental Disorders"}], "browseLeaves"=>[{"id"=>"M15376", "name"=>"Schizophrenia", "asFound"=>"Schizophrenia", "relevance"=>"HIGH"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "asFound"=>"Mental Disorders", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M12706", "name"=>"Obsessive-Compulsive Disorder", "asFound"=>"Obsessive-Compulsive Disorder", "relevance"=>"HIGH"}, {"id"=>"M6419", "name"=>"Compulsive Personality Disorder", "asFound"=>"Compulsive Disorder", "relevance"=>"HIGH"}, {"id"=>"M8991", "name"=>"Tourette Syndrome", "asFound"=>"Tourette Syndrome", "relevance"=>"HIGH"}, {"id"=>"M13462", "name"=>"Personality Disorders", "relevance"=>"LOW"}, {"id"=>"M21838", "name"=>"Schizophrenia Spectrum and Other Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4324", "name"=>"Anxiety Disorders", "relevance"=>"LOW"}, {"id"=>"M25603", "name"=>"Ganglion Cysts", "relevance"=>"LOW"}, {"id"=>"M16358", "name"=>"Synovial Cyst", "relevance"=>"LOW"}, {"id"=>"M4774", "name"=>"Basal Ganglia Diseases", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M16739", "name"=>"Tic Disorders", "relevance"=>"LOW"}, {"id"=>"M22132", "name"=>"Tics", "relevance"=>"LOW"}, {"id"=>"M12029", "name"=>"Movement Disorders", "relevance"=>"LOW"}, {"id"=>"M22092", "name"=>"Heredodegenerative Disorders, Nervous System", "relevance"=>"LOW"}, {"id"=>"M21558", "name"=>"Neurodegenerative Diseases", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"M30644", "name"=>"Neurodevelopmental Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M15512", "name"=>"Serotonin", "relevance"=>"LOW"}, {"id"=>"M7473", "name"=>"Dopamine", "relevance"=>"LOW"}, {"id"=>"M249453", "name"=>"2beta-carbomethoxy-3beta-(4-iodophenyl)tropane", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Cardiotonic Agents", "abbrev"=>"CaAg"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "enrollmentInfo"=>{"count"=>112}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1998-05"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2003-05", "completionDateStruct"=>{"date"=>"2003-05"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Receptors", "Re-Uptake", "Neurotransmitters", "Neuroimaging", "Drug Abuse", "Serotonin", "Brain Scan", "Tourette's Syndrome", "Obsessive Compulsive Disorder", "Schizophrenia", "Normal Volunteer"], "conditions"=>["Healthy", "Mental Disorder", "Obsessive Compulsive Disorder", "Schizophrenia", "Tourette Syndrome"]}, "referencesModule"=>{"references"=>[{"pmid"=>"6640008", "type"=>"BACKGROUND", "citation"=>"Bogerts B, Hantsch J, Herzer M. A morphometric study of the dopamine-containing cell groups in the mesencephalon of normals, Parkinson patients, and schizophrenics. Biol Psychiatry. 1983 Sep;18(9):951-69."}, {"pmid"=>"2760605", "type"=>"BACKGROUND", "citation"=>"Czudek C, Reynolds GP. [3H] GBR 12935 binding to the dopamine uptake site in post-mortem brain tissue in schizophrenia. J Neural Transm. 1989;77(2-3):227-30. doi: 10.1007/BF01248935."}, {"pmid"=>"8265656", "type"=>"BACKGROUND", "citation"=>"Innis RB, Seibyl JP, Scanley BE, Laruelle M, Abi-Dargham A, Wallace E, Baldwin RM, Zea-Ponce Y, Zoghbi S, Wang S, et al. Single photon emission computed tomographic imaging demonstrates loss of striatal dopamine transporters in Parkinson disease. Proc Natl Acad Sci U S A. 1993 Dec 15;90(24):11965-9. doi: 10.1073/pnas.90.24.11965."}]}, "descriptionModule"=>{"briefSummary"=>"Abnormalities in the re-uptake of dopamine and serotonin have been described in various neuropsychiatric disorders and substance abuse. \\[I-123\\] Beta-CIT is a recently developed radioligand for SPECT imaging of dopamine and serotonin transporters. \\[I-123\\]Beta-CIT SPECT has been used at the SPECT-lab of the Clinical Brain Disorders Branch in over fifty subjects without adverse events. Due to the trace concentrations used, a pharmacological effect of Beta-CIT is unlikely and has not been observed. The purpose of this study is to use Beta-CIT and SPECT to study the expression of dopamine and serotonin transporters in vivo in normal controls and various patient populations to address hypothesized abnormalities of the transporters in different disorders and to understand the effects of genetic variations in the genes of these transporters on their in vivo expression.", "detailedDescription"=>"Abnormalities in the re-uptake of dopamine and serotonin have been described in various neuropsychiatric disorders and substance abuse. \\[I-123\\] Beta-CIT is a recently developed radioligand for SPECT imaging of dopamine and serotonin transporters. \\[I-123\\]Beta-CIT SPECT has been used at the SPECT-Lab of the Clinical Brain Disorders Branch in over fifty subjects without adverse events. Due to the trace concentrations used, a pharmacological effect of Beta-CIT is unlikely and has not been observed. The purpose of this study is to use Beta-CIT and SPECT to study the expression of dopamine and serotonin transporters in vivo in normal controls and various patient populations to address hypothesized abnormalities of the transporters in different disorders and to understand the effects of genetic variations in the genes of these transporters on their in vivo expression."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>true, "eligibilityCriteria"=>"INCLUSION CRITERIA:\n\nNo Axis I or Axis II diagnoses.\n\nEXCLUSION CRITERIA FOR ALL SUBJECTS:\n\nIf the pregnancy test is positive or if the woman has reason to believe she might be pregnant, she will be excluded from this study.\n\nWomen who are breastfeeding will be excluded from this study to avoid unwarranted risk to their children.\n\nSubjects with a prior reaction to iodine, iodine compounds, or shellfish will be excluded from this study.\n\nSubjects with a history of thyroid disease or dysfunction will be excluded from this study.\n\nSubjects with a history of recent substance abuse will be excluded from this study.\n\nSubjects with metal objects in their bodies as specified in our MRI protocol (91-M-0124) will be excluded from this study.\n\nIf a structural abnormality of the brain is detected on MRI, subjects will be excluded from the study.\n\nEXCLUSION CRITERIA FOR NORMAL CONTROLS:\n\nSubjects with an Axis I or Axis II disorder will be excluded.\n\nSubjects with concomitant medical or neurological disorders which require ongoing medication, or which may affect the central nervous system will be excluded."}, "identificationModule"=>{"nctId"=>"NCT00001771", "briefTitle"=>"I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"I-123 Beta-CIT SPECT Studies of Dopamine and Serotonin Transporters in Neuropsychiatric Patients and Normal Volunteers", "orgStudyIdInfo"=>{"id"=>"980094"}, "secondaryIdInfos"=>[{"id"=>"98-M-0094"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Mental Health (NIMH)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Mental Health (NIMH)", "class"=>"NIH"}}}}