Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000436

EU PAS number

EUPAS1000000436

Study ID

1000000436

Official title and acronym

DARWIN EU® - Prescription trends of ketamine and esketamine

DARWIN EU® study

Yes

Study countries

Denmark
Finland
France
Germany
Spain
United Kingdom

Study description

Ketamine and esketamine are authorised for use in anaesthesia and for sedation in medical procedures, as well as for managing treatment-resistant depression. The non-medical use of ketamine has become a growing concern within the European Union (EU), prompting law enforcement actions to monitor its illicit trafficking and misuse. To better understand the scope of this issue, we initiated a study to examine legitimate prescription trends for ketamine and esketamine separately.

Study status

Ongoing
Research institution 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