Use of Methylphenidate in Children and AdolescentsNCT03371069
Use of Methylphenidate in Children and Adolescents in France
An observational study of Use of Methylphenidate in Children and Adolescents, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The use of methylphenidate in children and adolescents in France from 2010 to 2015 Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Use of Methylphenidate in Children and Adolescents
- What is being tested?
- users of methylphenidate
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolesents who are users of methylphenidate
Who may be able to join
- children and adolescents (0-17 years)
- registered in the French Health Insurance Database from 2012-2015
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- users of methylphenidate
- Keywords
- methylphenidate, drug utilisation study, pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
users of methylphenidateOther
Children and adolescents who are users of methylphenidate, 2010 to 2015
| Study group | Role | What they receive |
|---|---|---|
| users of methylphenidate | Children and adolescents who are users of methylphenidate, 2010 to 2015 Receives: Other: users of methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 years
Secondary outcomes (2)
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.
Measured: 6 years
Co-prescription of methylphenidate and non-psychostimulant psychotropic drugs
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study startSep 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Use of Methylphenidate in Children and AdolescentsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florentia Kaguelidou, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371069
- Sponsor's protocol ID
- 15FKU-MPH
- Status last verified
- Nov 2017
- First submitted
- 7 Sep 2016
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Methylphenidate in Children and Adolescents in France
- ClinicalTrials.gov ID
- NCT03371069
- Acronym / sponsor ID
- 15FKU-MPH
- Keywords
- methylphenidate, drug utilisation study, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| users of methylphenidate | – | Other: users of methylphenidateChildren and adolescents who are users of methylphenidate, 2010 to 2015 |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolesents who are users of methylphenidate
Key inclusion criteria (2 listed)
- children and adolescents (0-17 years)
- registered in the French Health Insurance Database from 2012-2015
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| users of methylphenidateChildren and adolescents who are users of methylphenidate, 2010 to 2015 | Other | users of methylphenidate |
Primary outcome
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
2 secondary outcomes
Describe methylphenidate patterns of use over time
Time frame: 6 years
Co-prescription of methylphenidate and non-psychostimulant psychotropic drugs
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florentia Kaguelidou, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Use of Methylphenidate in Children and Adolescents, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
use of methylphenidate over time (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.