Use 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 identification

• EU PAS number:
  EUPAS19188
• Study ID:
  19189
• Official title and acronym:
  Use 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
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This 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).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Fundació Institut Català de Farmacologia (FICF)

Spain

Study timelines

Date when funding contract was signed

Planned: 14/07/2015

Study start date

Planned: 01/06/2016

Actual: 13/09/2016

Date of final study report

Planned: 31/12/2018

Sources of funding

EU institutional research programme

Other

More details on funding

Instituto de Salud Carlos III, European Regional Development Fund (FEDER))

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable