Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Methylphenidate in Children and Adolescents in France

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 7, 2016
First Posted Date December 13, 2017
Last Update Posted Date December 13, 2017
Actual Study Start Date September 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 7, 2017)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 7, 2017)
  • 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.
  • Co-prescription of methylphenidate and non-psychostimulant psychotropic drugs [ Time Frame: 6 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Use of Methylphenidate in Children and Adolescents in France
Official Title Use of Methylphenidate in Children and Adolescents in France
Brief Summary The use of methylphenidate in children and adolescents in France from 2010 to 2015
Detailed Description To describe the use of methylphenidate in children and adolescents in France from 2010 to 2015
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children and adolesents who are users of methylphenidate
Condition Use of Methylphenidate in Children and Adolescents
Intervention Other: users of methylphenidate
Children and adolescents who are users of methylphenidate, 2010 to 2015
Study Groups/Cohorts users of methylphenidate
Children and adolescents who are users of methylphenidate, 2010 to 2015
Intervention: Other: users of methylphenidate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 7, 2017)
1
Original Actual Enrollment Same as current
Actual Study Completion Date September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • children and adolescents (0-17 years)
  • registered in the French Health Insurance Database from 2012-2015
Sex/Gender
Sexes Eligible for Study: All
Ages up to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03371069
Other Study ID Numbers 15FKU-MPH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Florentia Kaguelidou, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2017