Study identification

EU PAS number

EUPAS19199

Study ID

26753

Official title and acronym

A non-interventional post-authorisation safety study (PASS) of vortioxetine in Europe

DARWIN EU® study

No

Study countries

Finland
Netherlands
Spain

Study description

This post-authorisation safety study (PASS) will be conducted using longitudinal automatic healthcare databases. It uses a non-comparative historical cohort design to explore:
- the patterns of use of vortioxetine in some populations or situations considered as important missing information
- the frequency of occurrence of selected important potential risks (suicidal behaviors, convulsions/seizures and severe renal or hepatic events potentially due to precipitation of metabolites in kidney and liver).
- the frequency of events of abuse/dependence for exploratory detection of potential signals, in relation with the important missing information Abuse/Dependence within “Misuse for Illegal Purposes”
- withdrawal due to lack of efficacy in patients aged 75 and over, in relation with the important missing information “Patients Aged 75 and Over”.
All incident vortioxetine users during the study period (between market entry date and end of study period) will be included. Study period will be the time it takes for the adequate sample size (N=2000 per database) to be reached.
Descriptive statistics will be used to estimate the proportion of patients with pre-defined characteristics (e.g. Proportion of incident users without any diagnostic codes for depression near the index date), as well as the incidence rates of certain pre-defined events (e.g. the incidence rate of events related to suicidal behaviors).

Study status

Finalised
Research institutions and networks

Institutions

H. Lundbeck
First published:
01/02/2024
Institution

Contact details

Non-interventional Research Manager H. Lundbeck A/S

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of final study report

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

More details on funding

H. Lundbeck A/S
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)