Status: Finalised First registered on: 14/05/2014
Last updated on: 21/03/2019
1. Study identification
EU PAS Register NumberEUPAS6539
Official titlePharmacoepidemiological Safety Study of Neuroleptics and Antidepressants in the Area of Geriatric Psychiatrics.
Study title acronymPhaSiNAg
Study typeObservational study
Brief description of the studyThe 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.
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 belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Website/Homepagewww.bips.uni-bremen.de
Details of (Primary) lead investigator
Title Dr
Last name Schink
First name Tania
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

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/10/201202/10/2012
Start date of data collection01/01/200401/01/2004
Start date of data analysis
Date of interim report, if expected
Date of final study report31/10/201419/12/2014
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 bodyFederal Institute for Drugs and Medical Devices80
Research councils
EU funding scheme
Otherinsitute funds20
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schink
First name Tania
Address line 1Achterstraße 30
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany
Phone number (incl. country code)49-421-21856865 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de
Public Enquiries
Title Dr 
Last name Schink 
First name Tania 
Address line 1Achterstraße 30 
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany 
Phone number (incl. country code)49-421-21856865 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de 
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