Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT05229627
Status:
UNKNOWN
Last Update Posted:
2022-02-08
First Post:
2015-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C041626', 'term': '5,10-dihydro-5-methylphenazine'}, {'id': 'D008774', 'term': 'Methylphenidate'}, {'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2015-12-31', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ)', 'timeFrame': '8 to 12 weeks', 'description': 'to define remission, using Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ), both in baseline and follow-up'}, {'measure': 'Clinical Global Impressions-Improvement scale (CGI-I)', 'timeFrame': '8 to 12 weeks', 'description': 'to define remission, participants will assessed by CGI-I in follow-up, and Clinical Global Impressions-Severity scale (CGI-S) in baseline.'}, {'measure': 'resting state functional magnetic resonance imaging (rs-fMRI)', 'timeFrame': '8 to 12 weeks', 'description': 'participants undergo resting state functional MRI (rs-fMRI) scan both in baseline and follow-up, and the duration for each rs-fMRI is 8 minutes.'}, {'measure': 'side effect assessment', 'timeFrame': '8 to 12 weeks', 'description': 'with clinical global impression scale'}], 'secondaryOutcomes': [{'measure': 'Structural magnetic resonance imaging (sMRI)', 'timeFrame': '8 to 12 week', 'description': 'participants undergo structural magnetic resonance imaging (sMRI) scan both in baseline and follow-up, and the duration for each sMRI is 5 minutes.'}, {'measure': 'Diffusion Tensor Imaging (DTI)', 'timeFrame': '8 to 12 weeks', 'description': 'participants undergo DTI scan both in baseline and follow-up, and the duration for each sMRI is 10 minutes.'}, {'measure': 'WEISS Functional Impairment Rating Scale-parent report (WFIRS-P)', 'timeFrame': '8 to 12 weeks', 'description': 'to assess the improvement of social function impairment in ADHD, participants will finish the WFIRS-P both in baseline and follow-up'}, {'measure': 'Behavior Rating Inventory of Executive Function (BRIEF)', 'timeFrame': '8 to 12 weeks', 'description': 'to assess the improvement of ecological executive function in ADHD, participants will finish the BRIEF both in baseline and follow-up'}, {'measure': 'The Cambridge Neuropsychological Tests Automated Battery（CANTAB）', 'timeFrame': '8 to 12 weeks', 'description': 'to assess the improvement of neuropsychological executive function in ADHD, participants will finish the executive functional test measured by CANTAB both in baseline and follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multimodule MRI, remission, MPH, ATX, ADHD'], 'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': 'Attention-deficit/hyperactivity disorder(ADHD) is highly prevalent among children and adolescents and often associated with poor long-term outcomes in adulthood. it is thus a serious public health problem. Methylphenidate(MPH) and Atomoxetine(ATX) are most frequently used for treating ADHD in many countries but the individual treatment response varies. Some patients present good response to either MPH or ATX with minimal or no symptoms left and optimal functioning(remission) after treatment, while others are poor responders to one of the two or even both. The underlying mechanism for the heterogenous responsiveness remains unknown. Thus we proposed to use multimodule magnetic resonance imaging(MRI) technology to explore the neural mechanisms of remission in children with ADHD treated with MPH or ATX.', 'detailedDescription': 'the main aim of the current study is to explore the mechanism of remission in children with ADHD treated by MPH or ATX. Baseline information including demographic information, clinical features including ADHD symptoms, cognitive assessments such as executive function, MRI scans including resting state functional MRI, structural MRI, and DTI would be acquired in each participant. after 8-12 weeks of treating with MPH or ATX, patients would be classified into subgroups of remitted and unremitted groups. all baseline tests would be acquired again at the end of the study. comparisons would be done to explore the remission mechanism induced by MPH or ATX'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the ADHD group would be recruited by the clinic for child psychiatry in Peking University sixth hospital; while the healthy control would be recruited in community setting', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- clinical diagnosis of ADHD, based on K-SADS-PL medication naive aged 6-16\n\nExclusion Criteria:\n\n\\- history of severe head injury (with coma) other severe physical problem or disease in nervous system intelligence quotient (IQ) \\< 80'}, 'identificationModule': {'nctId': 'NCT05229627', 'briefTitle': 'Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Sixth Hospital'}, 'officialTitle': 'Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD Treated With Methylphenidate or Atomoxetine', 'orgStudyIdInfo': {'id': 'NSFC81471382'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy control', 'description': 'healthy controls, screened by K-SADS-PL'}, {'label': 'MPH induced Remission', 'description': 'patients show remission after 8-12 weeks of treatment with MPH', 'interventionNames': ['Drug: MPH']}, {'label': 'non responder to MPH', 'description': "patients don't show remission after 8-12 weeks of treatment with MPH", 'interventionNames': ['Drug: MPH']}, {'label': 'ATX induced remission', 'description': 'patients show remission after 8-12 weeks of treatment with ATX', 'interventionNames': ['Drug: ATX']}, {'label': 'non responder to ATX', 'description': "patients don't show remission after 8-12 weeks of treatment with ATX", 'interventionNames': ['Drug: ATX']}], 'interventions': [{'name': 'MPH', 'type': 'DRUG', 'otherNames': ['Concerta'], 'description': 'the drug would be prescribed to patients without any contraindication', 'armGroupLabels': ['MPH induced Remission', 'non responder to MPH']}, {'name': 'ATX', 'type': 'DRUG', 'otherNames': ['Strattera'], 'description': 'the drug would be prescribed to patients without any contraindication', 'armGroupLabels': ['ATX induced remission', 'non responder to ATX']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Qingjiu Cao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Sixth Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'the data would be published first and not yet decided to share with other research groups'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Sixth Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hangzhou Normal University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof. Dr.', 'investigatorFullName': 'Qingjiu Cao', 'investigatorAffiliation': 'Peking University Sixth Hospital'}}}}