Status: Planned
First registered on:
25/04/2017
Last updated on:
28/04/2017
1. Study identification
EU PAS Register NumberEUPAS18732
Official titleThe relationship between the month of birth and ADHD treatment
Study title acronym
Study typeObservational study
Brief description of the studyThere seems to be a relationship between a child’s month of birth and the diagnosis and treatment of attention deficit hyperactivity disorder (ADHD). Both underdiagnosis as well as overdiagnosis of ADHD can have consequences for the future of a child. The objective of this study is to determine if there is a relationship between the month of birth and the pharmacological treatment of ADHD in children in the Netherlands. The study cohort includes children and adolescents ≤ 24 years old who use ADHD medication, dispensed for the first time between 2006-2016.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupDivision of Pharmacoepidemiology & Clinical Pharmacology
Organisation/affiliationUtrecht Institute for Pharmaceutical Sciences
Details of (Primary) lead investigator
Title Dr
Last name Heerdink
First name Rob
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
Netherlands
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/02/2017
Start date of data collection01/06/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report01/01/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherDivision of Pharmacoepidemiology & Clinical Pharmacology100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Heerdink
First name Rob
Address line 1Universiteitsweg 99
Address line 2PO Box 80082
Address line 3
CityUtrecht
Postcode3508 TB
CountryNetherlands
Phone number (incl. country code)31-6-20283616
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Heerdink
First name Rob
Address line 1Universiteitsweg 99
Address line 2PO Box 80082
Address line 3
CityUtrecht
Postcode3508 TB
CountryNetherlands
Phone number (incl. country code)31-6-20283616
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)N06BA04 (methylphenidate)
Substance class (ATC Code)N06BA02 (dexamfetamine)
Substance class (ATC Code)N06BA09 (atomoxetine)
7. Medical conditions to be studied
Medical condition(s)Yes
Attention deficit/hyperactivity disorder
8. Population under study
Age
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects20000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Risk assessment
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
Is there a relationship between the month of birth and the pharmacological treatment of ADHD in children and adolescents?
Are there primary outcomes?Yes
The start of ADHD medication.
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Follow-up, retrospective:
- From the month of birth until the first dispensing date for medication to treat ADHD.
- The period a child or adolescent uses medication to treat ADHD.
The first dispensing date is the index date. The follow-up period ends two years after the index date, at the end of the study period, after lost to follow-up or up to death, whichever comes first.
15. Data analysis plan
Please provide a brief summary of the analysis method
The analysis will be descriptive. The children receiving ADHD medication with a different month of birth will be compared. The age at which a child receives the treatment for the first time will be defined, it will be represented as the number of months from birth until the first dispensing date. Also the period the children use the ADHD medication will be analysed. The measures of occurrence and association are the incidence rates and the relative risks.
Analyses are stratified according to sex, age categories and the calendar year the ADHD medication is dispensed for the first time.
We will correct for the total number of births in different months/years.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
