Status: Ongoing First registered on: 22/02/2019
Last updated on: 26/02/2019
1. Study identification
EU PAS Register NumberEUPAS28375
Official titleUSE 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.
Study title acronymPEPSICAT
Study typeObservational study
Brief description of the studyThis 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.
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 applicableCatalan Health Department SLT006/17/00309 https://web.gencat.cat/web/shared/OVT/Departaments/SLT/Documents/Formularis_pdf/SUBV_Recerca_Resolucio-definitiva-de-concessio-de-la-subencio-PERIS-2018-2020.pdf AEMPS classification: EPA-OD. UMO 2007-17. Code: IUI-FLU-2018-01
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIDIAPJGol
Department/Research groupInstitut Universitari d'Investigació en Atenció Primària Jordi Gol
Organisation/affiliationIDIAPJGol
Website/Homepagewww.idiapjgol.org
Details of (Primary) lead investigator
Title Dr
Last name Ainhoa
First name Gomez-Lumbreras
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

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed16/02/2018
Start date of data collection01/06/201801/06/2018
Start date of data analysis14/06/2018
Date of interim report, if expected05/10/201805/10/2018
Date of final study report31/12/2020
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 bodyCatalan Health Department100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Gome-Lumbreras
First name Ainhoa
Address line 1Gran Via de les Corts Catalanes 587-àtic
Address line 2 
Address line 3 
CityBarcelona 
Postcode08007 
CountrySpain
Phone number (incl. country code)34-934824605 
Alternative phone number 
Fax number (incl. country code) 
Email address agomez@idiapjgol.info
Public Enquiries
Title Dr 
Last name Gomez-Lumbreras 
First name Ainhoa 
Address line 1Gran Via de les Corts Catalanes 587-àtic 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08007 
CountrySpain 
Phone number (incl. country code)34-934824605 
Alternative phone number 
Fax number (incl. country code) 
Email address agomez@idiapjgol.info 
Top