Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N05A) ANTIPSYCHOTICS
ANTIPSYCHOTICS
Population studied

Short description of the study population

The study cohort will comprise all paediatric individuals between 1- and 18-years old present in the database during the study period (i.e., 2013-2023).
Additional eligibility criteria for patient-level antipsychotic characterisation and drug utilisation, and for the calculation of incidence rates will be applied, where a minimum follow-up of 365 days of data availability will be required to exclude individuals with a prior use of the respective drug of interest:
- When overall, no prior use of any of the common antipsychotics will be required.
In other words, users with prior use of any of the antipsychotics of interest will be excluded from the analysis.
- When stratified by specific antipsychotic drug, no prior use of the specific antipsychotic will be required.
In other words, users with prior use of the same antipsychotic will be excluded from the analysis.
Study design details

Study design

Retrospective cohort studies will be conducted using routinely collected health data from 7 databases.

Main study objective

1. To characterise children with a first prescription of an antipsychotic in each database in terms of age, sex, comorbidities and indication of use.
2. To measure trends in the incidence/prevalence of antipsychotic prescribing in children overall, by typical/atypical grouping and separately for 11 drug substances in each database. Results would be stratified by calendar year, age and sex.
3. To characterise first use of antipsychotic initiation in children (overall, by typical/atypical use, and by the 11 prespecified drug substances) in terms of dose and duration in each database. Results will be stratified by age and sex.