Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00879320
Status:
COMPLETED
Last Update Posted:
2013-10-22
First Post:
2009-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healthy Lifestyle in Adults With Attention Deficit Hyperactivity Disorder
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-21', 'studyFirstSubmitDate': '2009-04-09', 'studyFirstSubmitQcDate': '2009-04-09', 'lastUpdatePostDateStruct': {'date': '2013-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of ADHD and control subject health habits will be assessed by subject-rated questionnaires and health measures, such as vital signs and blood draw results.', 'timeFrame': '1 time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD', 'health', 'healthy lifestyle'], 'conditions': ['ADHD', 'Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the relationship between ADHD and the overall health of someone with ADHD. People who have ADHD have trouble paying attention, concentrating, organizing, and planning. They may have trouble in school, at work, and at home. The investigators are interested in finding out whether these difficulties have had any influence in the past, current, or future health problems of someone with ADHD. About 100 people with ADHD and 100 people without ADHD will take part in this research study, all through Massachusetts General Hospital (MGH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults ages 18-55 who have ADHD (for ADHD group) Healthy adult volunteers ages 18-55 who do not have ADHD (control group)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nADHD Subjects\n\n1. Signed written informed consent to participate in the study.\n2. Age: 18 - 60 (inclusive).\n3. Current diagnosis of DSM-IV ADHD by structured interview. Late age of onset acceptable for participation provided ADHD symptoms meet full criteria currently.\n\nControl Subjects\n\n1. Signed written informed consent to participate in the study.\n2. Age: 18 - 60 (inclusive).\n3. Subjects must have \\<3 symptoms in each domain (Inattention and Hyperactive/Impulsive) and \\<5 total symptoms in both domains on the DSM-IVADHD module of the structured interview.\n\nExclusion Criteria:\n\n1. Diagnosis of any psychotic disorder or Autism.\n2. Mental impairment as evidenced by a Full Scale I.Q. less than 80.\n3. Major sensorimotor handicaps such as deafness or blindness.\n4. Subject currently taking antipsychotic medication or mood stabilizers.\n5. Inadequate command of the English language.'}, 'identificationModule': {'nctId': 'NCT00879320', 'briefTitle': 'Healthy Lifestyle in Adults With Attention Deficit Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Healthy Lifestyle in Adults With ADHD', 'orgStudyIdInfo': {'id': '2008-P-002056'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Adults with ADHD'}, {'label': '2', 'description': 'Healthy adults without ADHD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Thomas Spencer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shire', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology', 'investigatorFullName': 'Thomas J. Spencer, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}