Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-03-07 @ 11:47 PM
Study NCT ID:
NCT03371069
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2016-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Methylphenidate in Children and Adolescents in France
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-07', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2017-12-07', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'use of methylphenidate over time', 'timeFrame': '6 years', 'description': 'Describe of the use of methylphenidate over time to determine the impact of regulatory information of appropriate prescription conditions of use in September 2012'}], 'secondaryOutcomes': [{'measure': 'Describe methylphenidate patterns of use over time', 'timeFrame': '6 years', 'description': 'Pharmaceutical specialties (immediate or extended release forms) prescribed by type of delivery: initial or renewals.\n\nProfile of prescribers: hospital or private practice (general practitioners, specialists) depending on type of prescription (initial or renewal); geographical distribution of the prescribers Profile of patients: sex, average age and age classes (0-23 months, 2-5 years, 6-11 years, 12-17 years), socioeconomic status, long-lasting diseases status for psychosis, severe personality disorder, mental retardation.\n\nPattern of methylphenidate use: duration of treatment, prolonged use, interruption of treatment.'}, {'measure': 'Co-prescription of methylphenidate and non-psychostimulant psychotropic drugs', 'timeFrame': '6 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['methylphenidate', 'drug utilisation study', 'pediatrics'], 'conditions': ['Use of Methylphenidate in Children and Adolescents']}, 'descriptionModule': {'briefSummary': 'The use of methylphenidate in children and adolescents in France from 2010 to 2015', 'detailedDescription': 'To describe the use of methylphenidate in children and adolescents in France from 2010 to 2015'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolesents who are users of methylphenidate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children and adolescents (0-17 years)\n* registered in the French Health Insurance Database from 2012-2015'}, 'identificationModule': {'nctId': 'NCT03371069', 'briefTitle': 'Use of Methylphenidate in Children and Adolescents in France', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Use of Methylphenidate in Children and Adolescents in France', 'orgStudyIdInfo': {'id': '15FKU-MPH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'users of methylphenidate', 'description': 'Children and adolescents who are users of methylphenidate, 2010 to 2015', 'interventionNames': ['Other: users of methylphenidate']}], 'interventions': [{'name': 'users of methylphenidate', 'type': 'OTHER', 'description': 'Children and adolescents who are users of methylphenidate, 2010 to 2015', 'armGroupLabels': ['users of methylphenidate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert Debré, APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Florentia Kaguelidou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}