Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-30 @ 5:37 PM
Study NCT ID:
NCT01447004
Status:
UNKNOWN
Last Update Posted:
2011-10-05
First Post:
2011-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2011-10-04', 'studyFirstSubmitDate': '2011-10-04', 'studyFirstSubmitQcDate': '2011-10-04', 'lastUpdatePostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'Heavy metal has been reported that it can cause attention deficit and behavioral disturbance. The investigators hypothesis is that heavy metal is associated with children with attention deficit/hyperactivity disorder(ADHD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview\n\n * Subjects signed a written consent form voluntarily.\n * Patient 's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates, or legal guardian.\n * Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time\n\nExclusion Criteria:\n\n* Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder.\n* Subjects who have significant suicidal ideation or homicidal ideation\n* Subjects with mental retardation\n* Subjects with Tourette's syndrome requiring drug therapy.\n* Subjects who currently have a significant medical conditions (e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma).\n* Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results, including serum chemistries and hematology.\n* Subjects who have been administrated alpha-2 adrenergic receptor agonist,antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant within recent 2 months.\n* Subjects who dyed their hair within 8 weeks"}, 'identificationModule': {'nctId': 'NCT01447004', 'briefTitle': 'a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'officialTitle': 'a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea', 'orgStudyIdInfo': {'id': 'hushhirb'}}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang, Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun Ju Hong', 'role': 'CONTACT', 'phone': '+82-31-380-3750'}], 'facility': 'Hallym university sacred heart hospital'}], 'centralContacts': [{'name': 'Hyun Ju Hong', 'role': 'CONTACT', 'email': 'hongdr@chol.com, hjhong@hallym.or.kr', 'phone': '+82-31-380-3750'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}