Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT06077669
Status:
WITHDRAWN
Last Update Posted:
2024-03-15
First Post:
2023-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multimodal Brain Imaging of Methylphenidate in Children and Adolescents 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': 'D008774', 'term': 'Methylphenidate'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study withdrawn in IRB by PI', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-04-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2023-10-05', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BOLD signal during response inhibition', 'timeFrame': 'Approximately 90 minutes after dose', 'description': 'Blood oxygenation level dependent (BOLD) signal (brain activity during functional magnetic resonance imaging (fMRI), arbitrary units) in the anterior cingulate cortex during response inhibition.'}, {'measure': 'BOLD signal during working memory', 'timeFrame': 'Approximately 90 minutes after dose', 'description': 'BOLD signal (brain activity during fMRI, arbitrary units) in the frontal cortex during working memory'}, {'measure': 'Glutamate level in the anterior cingulate cortex', 'timeFrame': 'Approximately 2 hours after dose', 'description': 'Glutamate level (measured by magnetic resonance spectroscopy (MRS), institutional units) in the anterior cingulate cortex (ACC).'}, {'measure': 'Glutamate level in the dorsolateral prefrontal cortex', 'timeFrame': 'Approximately 2 hours after dose', 'description': 'Glutamate level (measured by MRS, institutional units) in the dorsolateral prefrontal cortex'}, {'measure': 'Cognitive performance as assessed by the Flanker performance task', 'timeFrame': 'Approximately 3 hours after dose', 'description': 'NIH Toolbox Cognitive Battery Flanker task, score range 0 to 20, higher score is better performance'}, {'measure': 'Working memory performance', 'timeFrame': 'Approximately 3 hours after dose', 'description': 'NIH Toolbox Cognitive Battery working memory task (list sorting), score range 0 to 26, higher score is better performance'}], 'secondaryOutcomes': [{'measure': 'ADHD as assessed by the Connors 3', 'timeFrame': 'At each study visit, approximately 3 hours after dose', 'description': 'Connors 3rd edition ADHD assessment, lower score means less symptoms, typical scores are 40 to 59, above 65 is an elevated score (meaning more concerns than are typically reported)'}, {'measure': 'NIH Toolbox Cognitive Battery', 'timeFrame': 'Approximately 3 hours after dose', 'description': 'Cognition Fluid Composite, Cognition Crystallized Composite, Cognition Total Composite Score, and other individual test scores'}, {'measure': 'Methylphenidate plasma levels', 'timeFrame': 'Approximately 90 min and 150 min after dose', 'description': 'Methylphenidate plasma levels will be drawn before and after brain imaging on each visit'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': 'The goal of this proposal is to develop brain imaging tools to measure the effects of methylphenidate in children and adolescents with attention deficit hyperactivity disorder (ADHD). Methylphenidate is an FDA-approved treatment for ADHD. Specifically, the investigators will correlate brain activity during cognitive tasks and brain chemistry with cognitive performance. These measures could help the investigators understand how current ADHD medications work and then could be used to develop novel drugs to treat ADHD in children and adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 6 to 18 years\n* Diagnosis of ADHD\n* A score of at least 3 (mildly ill) on the clinician administered Clinical Global Impressions-Severity (CGI-S)\n\nExclusion Criteria:\n\n* Currently taking stimulant medications (within one week of first study visit). Patients will not be asked to discontinue any treatments for the purpose of this research study. Subjects will include treatment naïve patients and patients who were previously treated with stimulant medications, but are not currently treated, and meet study criteria.\n* Having an adverse reaction to methylphenidate, or other stimulant medication\n* Current psychiatric disorder, including bipolar I or II disorder, major depressive, disorder, obsessive-compulsive disorder, autism spectrum disorder, Tourette syndrome, or history of psychosis\n* Patient is at risk for clinically significant deterioration due to study protocol, as assessed by primary medical investigator (Dr. Grant)\n* Confirmed genetic disorder with cognitive and/or behavioral disturbances\n* Active, unstable medical illness that may interfere with cognition or compromises safety of the patient\n* History of head trauma with loss of consciousness or any evidence of functional impairment due to, and persisting after, head trauma\n* Neurological disorder, mental retardation, intellectual or disability, or other non-ADHD cause of cognitive impairment\n* Pregnant or breast-feeding women\n* Having a contraindication to MRI, including a pacemaker, defibrillator or other medical implant, other metal objects, or claustrophobia, or for having braces or other metal in the head region (likely to create an artifact on the MRI scans).\n* Currently smoking or using controlled or illicit substances, including alcohol.'}, 'identificationModule': {'nctId': 'NCT06077669', 'briefTitle': 'Multimodal Brain Imaging of Methylphenidate in Children and Adolescents With ADHD', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Children and Adolescents With ADHD', 'orgStudyIdInfo': {'id': 'IRB00408678'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylphenidate - low dose', 'description': '5 mg of methylphenidate', 'interventionNames': ['Drug: Methylphenidate']}, {'type': 'EXPERIMENTAL', 'label': 'Methylphenidate - high dose', 'description': '10 mg of methylphenidate', 'interventionNames': ['Drug: Methylphenidate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Methylphenidate', 'type': 'DRUG', 'otherNames': ['Ritalin'], 'description': 'Single oral dose of methylphenidate (5mg or 10 mg)', 'armGroupLabels': ['Methylphenidate - high dose', 'Methylphenidate - low dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Kristin Bigos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be deposited at 12 months after the start of recruitment, and every 6 months following', 'ipdSharing': 'YES', 'description': 'De-identified data will be deposited in the National Institute of Mental Health Data Archive (NDA) will be collected for each subject. All raw and processed phenotypic data (clinical, cognitive, imaging) will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}