Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT00307268
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2006-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-21', 'studyFirstSubmitDate': '2006-03-23', 'studyFirstSubmitQcDate': '2006-03-23', 'lastUpdatePostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD Effectiveness'], 'conditions': ['Attention-Deficit/Hyperactivity Disorder (ADHD)']}, 'referencesModule': {'references': [{'pmid': '28093033', 'type': 'DERIVED', 'citation': 'Craig SG, Weiss MD, Hudec KL, Gibbins C. The Functional Impact of Sleep Disorders in Children With ADHD. J Atten Disord. 2020 Feb;24(4):499-508. doi: 10.1177/1087054716685840. Epub 2017 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate clinical effectiveness of medication treatment for ADHD. It is hypothesized that the effectiveness is lower than efficacy outcomes measured in clinical trials', 'detailedDescription': 'This is a prospective, long-term, observational study of routine clinical care. The study measurements will be integrated into the clinical assessment and follow-up procedures of the outpatient services under the Provincial ADHD Program. The study is designed for systematic follow-up of children and adolescents, diagnosed with ADHD irrespective of comorbidity or whether they elect to receive medication treatment. Evaluations occur every 6 months for 24 months. The population to be examined is children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical assessment. No studies have been conducted that have evaluated the outcome of core ADHD symptoms in a clinic setting. Metaanalysis of clinical trials of medication treatment for ADHD have suggested an effect size of approximately 0.8. Because of the heterogeneity of the clinic sample, a much lower effect size can be anticipated. Two hundred patients will be enrolled in this study with primary measure of effectiveness being change in ADHD symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical assessment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMeet DSM-IV criteria for ADHD\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT00307268', 'briefTitle': 'Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adolescents With ADHD: An Observational, Long-Term Follow-up Study of Routine Clinical Care', 'orgStudyIdInfo': {'id': 'H05-70361'}}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Children's and Women's Health Centre of BC", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Margaret Weiss, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'Janssen-Ortho LLC', 'class': 'INDUSTRY'}, {'name': 'Purdue University', 'class': 'OTHER'}, {'name': 'Shire', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}