Use of Methylphenidate in Children and Adolescents in France

Use of Methylphenidate in Children and Adolescents Clinical Trial

Official title:

Use of Methylphenidate in Children and Adolescents in France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371069
• Other study ID #: 15FKU-MPH
• Status: Completed
• Phase: N/A
• First received: September 7, 2016
• Last updated: December 7, 2017
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• children and adolescents (0-17 years)

• registered in the French Health Insurance Database from 2012-2015

Related Conditions & MeSH terms

• Use of Methylphenidate in Children and Adolescents

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Robert Debré, APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 years
Secondary	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.	6 years
Secondary	Co-prescription of methylphenidate and non-psychostimulant psychotropic drugs		6 years