Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000382

EU PAS number

EUPAS1000000382

Study ID

1000000382

Official title and acronym

DARWIN EU® - Antipsychotic prescribing in people with dementia in Europe: a descriptive analysis of trends and patient characteristics

DARWIN EU® study

Yes

Study countries

Belgium
Croatia
Denmark
Germany
Netherlands
Spain

Study description

Antipsychotic drugs have been associated with several adverse drug reactions, particularly in the elderly. Somnolence, hypotension, extrapyramidal side effects and gait abnormalities are well-recognised side effects that may in turn contribute to the risk of falls and fracture in elderly persons. Similarly, cardiovascular adverse effects, falls and injuries may increase mortality.
Antipsychotic drugs are indicated for the management of schizophrenia and bipolar disorder. Antipsychotics are also used to manage behavioral and psychological symptoms of dementia (BPSD) and recommendations over their use suggest they should be discontinued after BPSD symptoms resolve. Safety concerns have previously led to regulatory warnings and risk communications over their use.
Antipsychotic drugs can be classified into typical and atypical antipsychotics with different recommendations for their use. For example, guidelines recommend the preferential use of atypical antipsychotics when required for the management of BPSD.
The rationale of the study is to provide an overview of common antipsychotic prescribing in Europe, and to describe the characteristics of patients initiating antipsychotics. This may help to contextualize information contained in future antipsychotic periodic safety update reports.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Marta Pineda Moncusi

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

Protocol_P3-C1-013_Antipsychotics dementia_V2.pdf

English (726.91 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable