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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  BRINTELLIX
• Medical condition to be studied:
  Major depression

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  6000

Study design details

• Main study objective:
  Aims of this study are 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, the frequency of events of abuse/dependence, withdrawal due to lack of efficacy in patients aged 75 and over.
• Data analysis plan:
  In this non-comparative study, descriptive statistics will be used. Summary statistics (mean, standard deviation, median, inter-quartile range, minimum and maximum values) will be presented for continuous variables. Counts and percentages will be presented for categorical and binary variables. In addition, incidence rates (number of events divided by person-time at risk) will be calculated for selected events.