DARWIN EU® Rates of occurrence of treatment-related intercurrent events in patients with major depressive disorder

Study type

• Study topic:
  Disease /health condition
• 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

• Medical condition to be studied:
  Major depression

  Depression

Population studied

• Short description of the study population:
  9.5.1 Patient-level characterization of MDD treatment ; The study cohort comprised all patients, aged 12 years or older, with newly diagnosed MDD present in the respective databases during the study period (2013-2022) and with at least 365 days of data availability before this diagnosis. ; 9.5.2 Patient-level utilization of antidepressants ; All individuals aged 12 and above who are new users of antidepressants with incident MDD diagnosis in the ; period between 1st of January 2013 and 31st of December 2022 (or latest date available), with at least 1 year ; of data visibility prior to the date of their first prescription of the antidepressant class of interest. Because in this selection of new users, the criterion of 365 days data available before the MDD diagnosis was not applied,; individuals can be included who were not included in the cohort of newly diagnosed MDD patients.
• Age groups:
  • Adolescents (12 to < 18 years)
  • 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)
• Estimated number of subjects:
  19300000

Study design details

• Study design:
  • Patient-level characterisation (Objective 1 and 3); • Patient-level drug utilization (Objective 2)
• Main study objective:
  To examine the proportion of patients with newly diagnosed major depressive disorder who start treatment with antidepressants and psycholeptics and of those the proportion who switch or discontinue treatment by specific timepoints after treatment initiation, stratified by age group, sex, and country.
• Setting:
  This study was conducted using routinely collected data from 5 databases in 4 European countries (Germany, Spain, The Netherlands and the United Kingdom). All databases were previously mapped to the OMOP Common Data Model (CDM).
• Outcomes:
  Treatment initiation, treatment discontinuation and treatment switch.
• Data analysis plan:
  Percentage of patients initiating treatment with specific antidepressants or psycholeptics. Percentage of patients switching treatment to specific antidepressants or psycholeptics. Percentage of patients discontinuing treatment with specific antidepressants or psycholeptics. Estimation of the mean, median, 25th percentile, 75th percentile, minimum, and maximum durations of antidepressant use.