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CompletedNCT03371069Updated Dec 13, 2017

Use of Methylphenidate in Children and Adolescents in France

An observational study in Use of Methylphenidate in Children and Adolescents, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2017-12-13.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1
Ages
Up to 17 Years
Sex
All
01

Study summary

The use of methylphenidate in children and adolescents in France from 2010 to 2015

Read the detailed description

To describe the use of methylphenidate in children and adolescents in France from 2010 to 2015

02

Conditions studied

  • Use of Methylphenidate in Children and Adolescents

Keywords

  • methylphenidate
  • drug utilisation study
  • pediatrics
03

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children and adolesents who are users of methylphenidate

Eligibility criteria

Inclusion Criteria:

  • children and adolescents (0-17 years)
  • registered in the French Health Insurance Database from 2012-2015
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1 participant (actual)
Patient registry
No

Groups and cohorts

  • users of methylphenidate

    Children and adolescents who are users of methylphenidate, 2010 to 2015

    Other: users of methylphenidate

Interventions

  • Otherusers of methylphenidate

    Children and adolescents who are users of methylphenidate, 2010 to 2015

05

What researchers measure

Primary outcomes

  1. use of methylphenidate over time

    Describe of the use of methylphenidate over time to determine the impact of regulatory information of appropriate prescription conditions of use in September 2012

    Time frame: 6 years

Secondary outcomes

  1. Describe methylphenidate patterns of use over time

    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.

    Time frame: 6 years

  2. Co-prescription of methylphenidate and non-psychostimulant psychotropic drugs

    Time frame: 6 years

06

Study locations

1 site
  • Hôpital Robert Debré, APHP
    Paris, 75019, France
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03371069
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Dec 13, 2017
Start date
Sep 2015
Primary completion
Sep 2017
Completion
Sep 2017
Last update
Dec 13, 2017

Study contacts

Florentia Kaguelidou, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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