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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26753
• 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 behaviours, 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 charcateristics (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 behaviours).
• Study status:
  Ongoing

Research institutions and networks

Institutions

H. Lundbeck

Study timelines

Date when funding contract was signed

Planned: 19/08/2014

Actual: 19/08/2014

Study start date

Planned: 01/06/2017

Actual: 01/06/2017

Data analysis start date

Actual: 15/06/2017

Date of final study report

Planned: 31/12/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

H. Lundbeck A/S

Study protocol

Initial protocol

16034N Master Protocol v2.0 Abstract

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)