Status: Planned First registered on: 19/05/2017
Last updated on: 01/06/2017
1. Study identification
EU PAS Register NumberEUPAS19188
Official titleUse of antidepressant drugs and its association with risk of stroke, frequency of hospitalization, and mortality in an elderly population: a descriptive and analytic cohort study
Study title acronym
Study typeObservational study
Brief description of the studyThis is an observational study which will describe the use of antidepressants in an elderly population and assess its association with stroke, hospitalizations due to stroke and death in an elderly population during 2009-2015. A retrospective descriptive drug utilization study in a population aged over 65 and registered in the System for the Development of Research in Primary Care database (SIDIAP). Demographic and clinical patient characteristics, selected co-morbidities, clinical indications of antidepressant use, prescribed active ingredient of antidepressant, selected co-medications, prescribed dose and duration of antidepressants, switchers and discontinuers will be described. Prevalence of antidepressant use and rate of switchers and discontinuers will be measured. A retrospective study with matched cohorts will be conducted in a population aged over 65 and registered in the System for the Development of Research in Primary Care database (SIDIAP). Cases are incident users of antidepressant medication (tricyclic antidepressants, selective serotonin reuptake inhibitors, and other antidepressants), controls will not have used this type of medication. The research will evaluate the association of new prescription of antidepressants for any indication and occurrence of first episode of stroke, hospitalization or death. The information will be obtained from SIDIAP database (which has information of 5.8 million primary care patients from Intitut Català de la Salut), DATAMART® database (Pharmaceutical dispensation information from Catalan Health Service) and CMBD database (Hospital discharge registry from General Hospital of National Health System).
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
Centre to which the investigator belongsFICF
Department/Research group
Organisation/affiliationFundació Institut Català de Farmacologia
Website/Homepagewww.icf.uab.cat
Details of (Primary) lead investigator
Title Dr
Last name Ibañez
First name Luisa
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 signed14/07/2015
Start date of data collection01/06/201613/09/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2018
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 bodyInstituto de Salud Carlos III50
Research councils
EU funding schemeEuropean Regional Development Fund (FEDER))50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ibañez
First name Luisa
Address line 1Vall d'Hebron 119-129
Address line 2Antiga Escola Infermeria 
Address line 3Servei de Farmacologia Clínica 
CityBarcelona 
Postcode08039 
CountrySpain
Phone number (incl. country code)34934894105 
Alternative phone number34934894305 
Fax number (incl. country code) 
Email address li@icf.uab.cat
Public Enquiries
Title Dr 
Last name Ibañez 
First name Luisa 
Address line 1Vall d'Hebron 119-129 
Address line 2Antiga Escola Infermeria 
Address line 3Servei de Farmacologia Clínica 
CityBarcelona 
Postcode08039 
CountrySpain 
Phone number (incl. country code)34934894105 
Alternative phone number34934894305 
Fax number (incl. country code) 
Email address li@icf.uab.cat 
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