Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2026-01-11 @ 3:06 PM
Study NCT ID:
NCT00593112
Status:
COMPLETED
Last Update Posted:
2012-08-31
First Post:
2007-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'phammerness@partners.org', 'phone': '617-503-1040', 'title': 'Paul Hammerness, M.D.', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'OROS Methylphenidate', 'description': 'OROS = Osmotic-controlled Release Oral delivery System', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Healthy Volunteer Control group', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Methylphenidate', 'description': 'OROS = Osmotic-controlled Release Oral delivery System'}, {'id': 'OG001', 'title': 'Control', 'description': 'Healthy Volunteer Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 6 weeks Concerta treatment', 'description': 'Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)\n\nThis measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.', 'unitOfMeasure': 'MRS Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Seven subjects who completed the protocol were not included due to a lack of baseline comparison.'}, {'type': 'PRIMARY', 'title': 'H MRS Scan Results - Glutamine (Gln)/Ino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Methylphenidate', 'description': 'OROS = Osmotic-controlled Release Oral delivery System'}, {'id': 'OG001', 'title': 'Control', 'description': 'Healthy Volunteer Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '1.08', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 6 weeks Concerta treatment', 'description': 'Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)\n\nThis measure is a ratio of Glutamine (amino acid precursor to Glu) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.', 'unitOfMeasure': 'MRS Ratios', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Seven subjects who completed the protocol were not included due to a lack of baseline comparison.'}, {'type': 'PRIMARY', 'title': 'H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Methylphenidate', 'description': 'OROS = Osmotic-controlled Release Oral delivery System'}, {'id': 'OG001', 'title': 'Control', 'description': 'Healthy Volunteer Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '2.58', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 6 weeks Concerta treatment', 'description': "Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)\n\nThis measure is a ratio of Glutamate and it's precursor, Glutamine, to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.", 'unitOfMeasure': 'MRS Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Seven subjects who completed the protocol were not included due to a lack of baseline comparison.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OROS Methylphenidate', 'description': 'OROS = Osmotic-controlled Release Oral delivery System'}, {'id': 'FG001', 'title': 'Control', 'description': 'Healthy Volunteer Control group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Scan Anxiety', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Abnormal Scan', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unreadable Scan', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OROS Methylphenidate', 'description': 'OROS = Osmotic-controlled Release Oral delivery System'}, {'id': 'BG001', 'title': 'Control', 'description': 'Healthy Volunteer Control group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-22', 'studyFirstSubmitDate': '2007-12-28', 'resultsFirstSubmitDate': '2011-01-07', 'studyFirstSubmitQcDate': '2008-01-11', 'lastUpdatePostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-06', 'studyFirstPostDateStruct': {'date': '2008-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino)', 'timeFrame': 'after 6 weeks Concerta treatment', 'description': 'Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)\n\nThis measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.'}, {'measure': 'H MRS Scan Results - Glutamine (Gln)/Ino', 'timeFrame': 'after 6 weeks Concerta treatment', 'description': 'Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)\n\nThis measure is a ratio of Glutamine (amino acid precursor to Glu) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.'}, {'measure': 'H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino', 'timeFrame': 'after 6 weeks Concerta treatment', 'description': "Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)\n\nThis measure is a ratio of Glutamate and it's precursor, Glutamine, to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HMRS Scanning', 'ADHD', 'Child', 'Adolescent', 'HMRS Scans'], 'conditions': ['ADHD']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://massgeneral.org/pediatricpsych/home.html', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD. Specific hypotheses are as follows:\n\nHypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine + phosphocreatine (Glu/Cr) than matched HCS.\n\nHypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.', 'detailedDescription': 'The primary objective of this study is to use 1H MRS to assess Glutamate (Glu), myo-Inositol (Ino), and creatine + phosphocreatine (Cr) levels in brain regions of interest in 20 children with ADHD between the ages of 12-17 years old, before and after a six-week open treatment trial with OROS methylphenidate. For comparison, 1H MRS will also be obtained from 20 controls matched by age and gender. We also will scan 20 children with ADHD between the ages of 12-17 years old that are currently enrolled in the protocol entitled "Prevention of Cigarette Smoking in ADHD Youth with Concerta" (2003-P-001313) and on a stable dose of Concerta. These 20 children will be scanned once while on medication and once while off medication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects, 12-17 years of age.\n2. ADHD subjects must meet study criteria for the "Prevention of Cigarette Smoking in ADHD Youth with CONCERTA Protocol"; #2003-P-001313.\n3. Control subjects must not meet full DSM-IV criteria for Attention Deficit Hyperactivity Disorder, or any other current major psychiatric disorder.\n4. Each subject and his/her authorized legal representative must understand the nature of this proposed study, and must sign informed consent and informed assent documents.\n5. Subject and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with study procedures.\n\nExclusion Criteria:\n\n1. Clinically significant chronic medical condition including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.\n2. Organic brain disorders or mental retardation (I.Q. \\<75).\n3. Contraindication to MRI including presence of metal or surgical devices (plates, implants, braces or other items).\n4. Pregnancy; women of child bearing potential must be using a medically approved method of birth control. Women of child bearing potential will receive a urinary pregnancy test prior to each MR scanning session.\n5. Severe phobia of being in small, enclosed spaces.\n6. Investigator and his/her immediate family; defined as the investigator\'s spouse, parent, child, grandparent, or grandchild will not be eligible to participate in the treatment arm of the study.'}, 'identificationModule': {'nctId': 'NCT00593112', 'briefTitle': 'Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Pilot Study of Proton Magnetic Spectroscopy in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) Before and After Treatment With Osmotic-controlled Release Oral Delivery System (OROS) Methylphenidate', 'orgStudyIdInfo': {'id': '2005-P-002180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OROS Methylphenidate', 'interventionNames': ['Drug: OROS methylphenidate']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Healthy Volunteer Control group', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'OROS methylphenidate', 'type': 'DRUG', 'otherNames': ['Concerta'], 'description': 'Concerta is given in capsule form with a minimum dose of 18 mg/day and a max of 126 mg/day. Subjects take Concerta once per day for 6 weeks.', 'armGroupLabels': ['OROS Methylphenidate']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Paul Hammerness, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Investigator, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD', 'investigatorFullName': 'Paul Hammerness, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}