Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT01130467
Status:
UNKNOWN
Last Update Posted:
2010-08-10
First Post:
2010-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Event-related Potentials in Management of Children With Attention-deficit/Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-07-18', 'releaseDate': '2013-05-01'}], 'estimatedResultsFirstSubmitDate': '2013-05-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}, {'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}, {'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'lastUpdateSubmitDate': '2010-08-08', 'studyFirstSubmitDate': '2010-05-24', 'studyFirstSubmitQcDate': '2010-05-25', 'lastUpdatePostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chinese version of SNAP-IV Rating Scale', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Event-related potential', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'keywords': ['Attention Deficit Disorders with Hyperactivity', 'Attention Deficit Disorder', 'Event related potential'], 'conditions': ['Attention Deficit Disorders With Hyperactivity', 'Attention Deficit Disorder', 'Hyperkinetic Syndrome']}, 'referencesModule': {'references': [{'pmid': '12559225', 'type': 'BACKGROUND', 'citation': 'Barry RJ, Johnstone SJ, Clarke AR. A review of electrophysiology in attention-deficit/hyperactivity disorder: II. Event-related potentials. Clin Neurophysiol. 2003 Feb;114(2):184-98. doi: 10.1016/s1388-2457(02)00363-2.'}]}, 'descriptionModule': {'briefSummary': 'The investigators try to objectively and scientifically explore various brain function impairments in ADHD children by electrophysiologic tests, with and without medication.', 'detailedDescription': 'The aims of this study are to explore the various cognitive impairments of ADHD children, to differentiate various subtypes of ADHD children, and to investigate the efficacy of anti-ADHD drugs on various cognitive performance of ADHD children by event-related potentials(ERP).\n\nChildren, aged six to 18 years old, are enrolled and assigned to three groups (normal control, pure ADHD, and ADHD with comorbidities). ADHD children fulfill the DSM-IV-TR criteria for the diagnosis of ADHD. ADHD children are evaluated by Chinese version of SNAP-IV Rating Scale for rating ADHD-related symptoms before and after medication. EEG and audiometric testing are required for every participant to exclude dialeptic seizures and hearing impairment respectively.\n\nMethylphenidate (either immediate-release or extended-release formulations) or atomoxetine Hydrochloride is given to ADHD participants.Continuous performance task (CPT) and ERP tasks are applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One hundred and fifty children, aged 6-18 years old, are enrolled. ADHD children fulfill the DSM-IV-TR criteria for the diagnosis of ADHD. ADHD children are evaluated by Chinese version of SNAP-IV Rating Scale for rating ADHD-related symptoms before and after medication. EEG and audiometric testing are required for every participant to exclude dialeptic seizures and hearing impairment respectively. Urine pregnancy test is performed to exclude pregnant participants. Each participant is evaluated by both pediatric neurologists and child psychiatrists after enrollment to delineate possible underlying comorbidities. Three groups of participants were assigned: normal control group, pure ADHD group and ADHD with comorbidity group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* health children\n* or clinical diagnosis of attention-deficit hyperactivity disorder\n\nExclusion Criteria:\n\n* hearing impairment\n* uncorrectable visual impairment\n* epilepsy'}, 'identificationModule': {'nctId': 'NCT01130467', 'briefTitle': 'Event-related Potentials in Management of Children With Attention-deficit/Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'orgStudyIdInfo': {'id': 'FEMH-IRB-098034-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal control'}, {'label': 'pure ADHD', 'interventionNames': ['Drug: methylphenidate', 'Drug: Atomoxetine', 'Behavioral: behavioral modification']}, {'label': 'ADHD with comorbidity', 'interventionNames': ['Drug: methylphenidate', 'Drug: Atomoxetine', 'Behavioral: behavioral modification']}], 'interventions': [{'name': 'methylphenidate', 'type': 'DRUG', 'otherNames': ['Ritalin, Concerta'], 'description': 'IR-MPH were started on a dose of 5 mg tid po, and this was increased to 10 mg tid and then to 15 mg tid as necessary. OROS-MPH was started on a dose of 18 mg qd, and this was increased to 36 mg qd and then to 54 mg qd as necessary.', 'armGroupLabels': ['ADHD with comorbidity', 'pure ADHD']}, {'name': 'Atomoxetine', 'type': 'DRUG', 'otherNames': ['Straterra'], 'description': 'Atomexetine was started (weight of 70 kg or less) 0.5 mg/kg/day orally and increased after a minimum of 3 days to a target dose of 1.2 mg/kg/day. The maximum dosage is 1.4 mg/kg/day or 100 mg/day (whichever is less).', 'armGroupLabels': ['ADHD with comorbidity', 'pure ADHD']}, {'name': 'behavioral modification', 'type': 'BEHAVIORAL', 'description': 'Parenting and teaching skill education', 'armGroupLabels': ['ADHD with comorbidity', 'pure ADHD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'MING-TAO YANG, MD', 'role': 'CONTACT', 'email': 'mingtao.yang@msa.hinet.net', 'phone': '+886-2-8966-7000'}, {'name': 'WANG-TSO LEE, MD, PhD', 'role': 'CONTACT', 'email': 'leeped@hotmail.com', 'phone': '+886-2-23123456', 'phoneExt': '71514'}, {'name': 'WANG-TSO LEE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'MING-TAO YANG, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Children Hospital, National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academia Sinica, Taiwan', 'class': 'OTHER'}, {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'MING-TAO YANG', 'oldOrganization': 'Department of Pediatrics, Far Eastern Memorial Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-05-01', 'type': 'RELEASE'}, {'date': '2013-07-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Far Eastern Memorial Hospital'}}}}