Use of Methylphenidate in Children and Adolescents in France

December 7, 2017 updated by: Assistance Publique - Hôpitaux de Paris
The use of methylphenidate in children and adolescents in France from 2010 to 2015

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Robert Debré, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adolesents who are users of methylphenidate

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 years
Co-prescription of methylphenidate and non-psychostimulant psychotropic drugs
Time Frame: 6 years
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Florentia Kaguelidou, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15FKU-MPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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