Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000549

EU PAS number

EUPAS1000000549

Study ID

1000000549

Official title and acronym

DARWIN EU® - Clozapine and the incidence of agranulocytosis over time

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Finland
Germany
Spain

Study description

Clozapine is an effective treatment for treatment-resistant schizophrenia and Parkinson’s disease psychosis, but it carries a risk of severe hematological complications, including neutropenia and agranulocytosis.
Emerging evidence suggests that the risk is highest in the initial months of treatment, yet stringent hematological monitoring requirements remain in place throughout long-term use.
These requirements may hinder clinical practice, leading to underuse, early treatment discontinuation, or reluctance to initiate therapy.
This study aims to provide epidemiological evidence on the incidence and timing of clozapine-associated neutropenia and agranulocytosis across Europe.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Dina Vojinovic

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
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable