Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medicinal product name

BRINTELLIX

Study drug International non-proprietary name (INN) or common name

VORTIOXETINE

Anatomical Therapeutic Chemical (ATC) code

(N06AX26) vortioxetine
vortioxetine

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.