Study identification

PURI

https://redirect.ema.europa.eu/resource/28503

EU PAS number

EUPAS28375

Study ID

28503

Official title and acronym

USE OF PSYCHOTROPIC DRUGS IN CHILDREN AND ADOLESCENTS IN CATALONIA. A cohort study with real world data from the electronic primary health care record from 2007-2017. (PEPSICAT)

DARWIN EU® study

No

Study countries

Spain

Study description

This project has four main objectives: to describe in children <18 years the use of psychotropic drugs during the last decade, to describe their psychiatric diagnoses, to describe the baseline characteristics when starting treatment with psychotropic drugs and, to describe the consumption pattern of psychotropic drugs. As secondary objectives: to analyse factors associated with the use of different psychotropic drugs and factors related to the diagnosis of mental illness in patients under treatment with psychotropic drugs and to describe the adherence to psychotropic treatment. As exploratory objectives, an attempt will be made to correlate the maternal obstetric and psychiatric history with the consumption of psychotropic medication in the offspring and to analyse the reasons for the lack of a diagnostic record of mental pathology in patients with psychotropic treatment. Methods: Descriptive observational study will from 2007-2017 in the population under the age of 18 with at least one prescription for a psychotropic drug. Two studies will be carried out: one to estimate the prevalence of psychotropic drug use and psychiatric pathology diagnoses and the second one to estimate the incidence of psychotropic drug use in the <18 year population. This population will be followed until the end of the study or the impossibility to obtain information (death/transfer). The treatment period with this first psychotropic drug and the addition of other psychotropic drugs or the change of psychotropic treatment will be analysed during the follow-up. Data source: SIDIAP (Sistema de Información para el Desarrollo de la Investigación en Atención Primaria) database, which contains anonymized clinical information on approximately 80% of the population of Catalonia (Spain). Information will be completed with data from the Basic Minimum Data Set for outpatient mental health care (CMBD-SMA). Data will be stratified by sex and age groups.

Study status

Ongoing
Research institution and networks

Institutions

Contact details

Gomez-Lumbreras Ainhoa

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Catalan Health Department
Study protocol
Initial protocol

PEPSICAT_ENCePP

English (283.36 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable