Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000219

EU PAS number

EUPAS1000000219

Study ID

1000000219

Official title and acronym

DARWIN EU® – Trends in utilisation of Attention-Deficit Hyperactivity Disorder (ADHD) Medications

DARWIN EU® study

Yes

Study countries

Belgium
Germany
Netherlands
Spain
United Kingdom

Study description

The overall aim of this study is to characterise the use of ADHD medications in the period of 2010 to 2023. The specific objectives are:
1. To estimate the monthly and yearly period prevalence of use of each ADHD medicine, overall and stratified by age and gender in each database.
2. To estimate the monthly, quarterly, and yearly incidence of use of each ADHD medicine, overall and stratified by age and gender in each database.
3. Among new users of each ADHD medicine, to identify the indication at the time of the initial prescribing/dispensing, overall and stratified by age, sex, and quarter.
4. Among new users of each ADHD medicine, to estimate the initial dose, cumulative dose, and time on treatment of the initial medication, overall and stratified by age, sex, indication at index, and quarter.
5. Among new users of any ADHD medicine, to estimate the total treatment duration, number of prescriptions overall and by medicine., stratified by initial medicine and quarter of the year.
6. To identify the treatment pathway of each individual who initiated an ADHD medicine, including treatment add-on, switch and concurrent medication/co-prescribing, stratify by calendar time of initiation.

Study status

Planned
Research institution and networks

Institutions

Networks

Contact details

Xintong Li

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_D2.2.3_Protocol_P3-C1-004_DUS_ADHD_V4.pdf

English (2.01 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable