Pharmacoepidemiological Safety Study of Neuroleptics and Antidepressants in the Area of Geriatric Psychiatrics (PhaSiNAg)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29000
• EU PAS number:
  EUPAS6539
• Study ID:
  29000
• Official title and acronym:
  Pharmacoepidemiological Safety Study of Neuroleptics and Antidepressants in the Area of Geriatric Psychiatrics (PhaSiNAg)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The use of neuroleptics and antidepressants in elderly patients has been associated with adverse drug reactions such as cerebrovascular and cardiovascular events, pneumonia, fractures, venous thromboembolism and higher all-cause mortality. Based on data from the German Pharmacoepidemiological Research Database (GePaRD), the PhaSINAg project will investigate the safety profiles of neuroleptics and antidepressants in elderly patients in consideration of co-morbidity and co-medication.. Furthermore, prescription patterns of neuroleptics and antidepressants in patients aged 65 years and older will be analyzed. Within this context, investigations on how previous risk minimization activities led to changes in prescription patterns and how administrative data may be used for systematic risk monitoring will be conducted.
• Study status:
  Finalised

Research institution and networks

Institutions

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Contact details

Tania Schink

Study contact

[e-mail]

Tania Schink

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 02/10/2012

Actual: 02/10/2012

Data collection

Planned: 01/01/2004

Actual: 01/01/2004

Date of final study report

Planned: 31/10/2014

Actual: 19/12/2014

Sources of funding

Other

More details on funding

Federal Institute for Drugs and Medical Devices, Insitute funds

Regulatory

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