Biological Markers in Attention Deficit/Hyperactivity Disorder (ADHD)

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Nctid: NCT00001206

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D006948", "term"=>"Hyperkinesis"}, {"id"=>"D001289", "term"=>"Attention Deficit Disorder with Hyperactivity"}, {"id"=>"D001523", "term"=>"Mental Disorders"}, {"id"=>"D000066553", "term"=>"Problem Behavior"}, {"id"=>"D019958", "term"=>"Attention Deficit and Disruptive Behavior Disorders"}], "ancestors"=>[{"id"=>"D065886", "term"=>"Neurodevelopmental Disorders"}, {"id"=>"D020820", "term"=>"Dyskinesias"}, {"id"=>"D009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D001526", "term"=>"Behavioral Symptoms"}], "browseLeaves"=>[{"id"=>"M4594", "name"=>"Attention Deficit Disorder with Hyperactivity", "asFound"=>"Attention Deficit", "relevance"=>"HIGH"}, {"id"=>"M4815", "name"=>"Mental Disorders", "asFound"=>"Behavior Disorder", "relevance"=>"HIGH"}, {"id"=>"M85", "name"=>"Problem Behavior", "asFound"=>"Disruptive Behavior", "relevance"=>"HIGH"}, {"id"=>"M9999", "name"=>"Hyperkinesis", "asFound"=>"Hyperactivity", "relevance"=>"HIGH"}, {"id"=>"M21830", "name"=>"Attention Deficit and Disruptive Behavior Disorders", "asFound"=>"Attention Deficit and Disruptive Behavior Disorders", "relevance"=>"HIGH"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M30644", "name"=>"Neurodevelopmental Disorders", "relevance"=>"LOW"}, {"id"=>"M22574", "name"=>"Dyskinesias", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>347}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1985-06-05"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2017-05-15", "completionDateStruct"=>{"date"=>"2017-05-15"}, "lastUpdateSubmitDate"=>"2019-12-13", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2019-12-16", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Attention Deficit Hyperactivity Disorder", "Disruptive Behavior Disorders", "Cerebrospinal Fluid", "Lumbar Puncture", "CSF", "Longitudinal Prospective Follow-Up", "Psychosocial Functioning", "Risk Factors", "Genetics"], "conditions"=>["Attention Deficit and Disruptive Behavior Disorder", "Attention Deficit Disorder With Hyperactivity"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8722742", "type"=>"BACKGROUND", "citation"=>"Hauser ER, Boehnke M, Guo SW, Risch N. Affected-sib-pair interval mapping and exclusion for complex genetic traits: sampling considerations. Genet Epidemiol. 1996;13(2):117-37. doi: 10.1002/(SICI)1098-2272(1996)13:23.0.CO;2-5."}, {"pmid"=>"8540892", "type"=>"BACKGROUND", "citation"=>"Thapar A, Hervas A, McGuffin P. Childhood hyperactivity scores are highly heritable and show sibling competition effects: twin study evidence. Behav Genet. 1995 Nov;25(6):537-44. doi: 10.1007/BF02327577."}, {"pmid"=>"9118321", "type"=>"BACKGROUND", "citation"=>"LaHoste GJ, Swanson JM, Wigal SB, Glabe C, Wigal T, King N, Kennedy JL. Dopamine D4 receptor gene polymorphism is associated with attention deficit hyperactivity disorder. Mol Psychiatry. 1996 May;1(2):121-4."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate individuals with Attention Deficit/Hyperactivity Disorder (ADHD) to learn more about the genetics of the disease.\n\nThis study is part of other ongoing studies of individuals with ADHD. The study participants have already undergone neurobiological measurements, particularly magnetic resonance imaging (MRI) of the brain, through other research studies. As a follow-up to these studies, participants will next undergo psychiatric interviews, neuropsychological tests, and another MRI. In addition to the clinical evaluation of the participants, further research will be conducted on the genetics of ADHD. These genetic studies will evaluate people with ADHD as well as their family members and a control group of healthy people.", "detailedDescription"=>"This protocol allows the continuing prospective longitudinal study of ADHD probands for whom we have neurobiological measures, particularly quantitative brain MRI. The follow-up consists of structured psychiatric interviews, and neuropsychological tests. Repeat MRI scans are obtained through protocol 89-M-0006.\n\nThe second purpose of this protocol is a study of the genetics of Attention-Deficit/Hyperactivity Disorder (ADHD). Subjects who have ADHD, their family members, and controls are studied under this protocol."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"17 years", "minimumAge"=>"6 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION REQUIREMENTS-PROBANDS:\n\nCurrent age of index probands: 15.21 plus or minus 3.42; previous participation in the NIMH Child Psychiatry Branch ADHD study.\n\nAge adjusted dimensional ratings (Conners Rating Scales-Revised, and Strengths and Weaknesses of ADHD and Normal Behavior (SWAN)) of hyperactivity/impulsivity greater than or equal to 95th percentile for index and second sibling. Primary ratings for the index proband will be provided by main teacher.\n\nUp to 150 ADHD probands for reassessment.\n\nConsent and assent obtained in writing.\n\nEXCLUSION CRITERIA - PROBANDS:\n\nPresence of other known genetic conditions that are likely to be etiologic.\n\nOnset of medical conditions that could produce symptoms of ADHD through non-genetic mechanisms (e.g., thyroid disorders, seizure disorders, inborn errors of metabolism, extremely low birth weight (less than 1000 gm), meningitis, intracranial pathology).\n\nPresence of other psychiatric disorders that can produce symptoms similar to ADHD (e.g., major depression, bipolar disorder, severe anxiety disorders, pervasive developmental disorders, psychotic disorders, post-traumatic stress disorder).\n\nPresence of neuropsychiatric conditions that may confound evaluation of ADHD (e.g., Tourette's syndrome, obsessive-compulsive disorder, or PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcus), intelligence quotient less than 80, reading achievement standard scores less than 75 or reading-intelligence discrepancy greater than 2 SD).\n\nINCLUSION REQUIRMENTS-RELATIVES:\n\nSubjects must be relatives of probands.\n\nConsent and assent obtained in writing.\n\nINCLUSION REQUIREMENTS -NORMAL VOLUNTEERS:\n\nUp to 150 newly accrued normal volunteers unrelated to probands.\n\nSame age range as probands.\n\nParent and teacher ratings within one SD of population means on ADHD/hyperactivity factors.\n\nConsent and assent obtained in writing.\n\nEXCLUSIONS - NORMAL VOLUNTEERS:\n\nPresence of ADHD.\n\nPresence of any other psychiatric disorders on structured psychiatric interview (DICA-IV).\n\nPresence of known genetic conditions.\n\nOnset, presence or history of medical conditions that could produce symptoms of ADHD through non-genetic mechanisms (e.g., thyroid disorders, seizure disorders, inborn errors of metabolism, extremely low birth weight (less than 1000 gm), meningitis, intracranial pathology)."}, "identificationModule"=>{"nctId"=>"NCT00001206", "briefTitle"=>"Biological Markers in Attention Deficit/Hyperactivity Disorder (ADHD)", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Biological Markers in Childhood Psychiatric Disorders", "orgStudyIdInfo"=>{"id"=>"850115"}, "secondaryIdInfos"=>[{"id"=>"85-M-0115"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "overallOfficials"=>[{"name"=>"Judith L Rapoport, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Institute of Mental Health (NIMH)"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Mental Health (NIMH)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}