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Use of Methylphenidate in Children and Adolescents in France

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ClinicalTrials.gov Identifier: NCT03371069
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
The use of methylphenidate in children and adolescents in France from 2010 to 2015

Condition or disease Intervention/treatment
Use of Methylphenidate in Children and Adolescents Other: users of methylphenidate

Detailed Description:
To describe the use of methylphenidate in children and adolescents in France from 2010 to 2015
Study Design
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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Use of Methylphenidate in Children and Adolescents in France
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
users of methylphenidate
Children and adolescents who are users of methylphenidate, 2010 to 2015
 Other: users of methylphenidate
Children and adolescents who are users of methylphenidate, 2010 to 2015


Outcome Measures
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Primary Outcome Measures :
  1. use of methylphenidate over time [ Time Frame: 6 years ]
    Describe of the use of methylphenidate over time to determine the impact of regulatory information of appropriate prescription conditions of use in September 2012


Secondary Outcome Measures :
  1. Describe methylphenidate patterns of use over time [ Time Frame: 6 years ]

    Pharmaceutical specialties (immediate or extended release forms) prescribed by type of delivery: initial or renewals.

    Profile 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.

    Pattern of methylphenidate use: duration of treatment, prolonged use, interruption of treatment.


  2. Co-prescription of methylphenidate and non-psychostimulant psychotropic drugs [ Time Frame: 6 years ]

Eligibility Criteria
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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolesents who are users of methylphenidate
Criteria

Inclusion Criteria:

  • children and adolescents (0-17 years)
  • registered in the French Health Insurance Database from 2012-2015
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371069


Locations
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France
Hôpital Robert Debré, APHP
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Florentia Kaguelidou, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03371069    
Other Study ID Numbers: 15FKU-MPH
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
methylphenidate
drug utilisation study
pediatrics
Additional relevant MeSH terms:
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Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents