Study identification

PURI

https://redirect.ema.europa.eu/resource/50105

EU PAS number

EUPAS38144

Study ID

50105

Official title and acronym

Survey to Assess the Effectiveness of SPRAVATO® Educational Materials for Additional Risk Minimization Measures in the European Union (PCSNSP002812)

DARWIN EU® study

No

Study countries

Austria
Belgium
France
Germany
Italy
Netherlands
Spain
Sweden

Study description

To determine the effectiveness of the medical education materials related to the understanding and management of SPRAVATO important identified risks of Drug abuse, Transient dissociative states and perception disorders, Disturbances in consciousness, and Blood pressure increased in Europe.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Christian von Holt

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Janssen
Study protocol
Initial protocol

Protocol-FD-PCSNSP002812-94975_EDMS-RIM-94975_2.0

English (223.71 KB - PDF)View document
Updated protocol

REDACTED_Protocol-Amend 3-FD-PCSNSP002812-94975_983036

English (934.26 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)