DARWIN EU® - Prescription trends of ketamine and esketamine

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N01AX03) ketamine

  ketamine

  (N01AX14) esketamine

  esketamine

  (N06AX27) esketamine

  esketamine

Population studied

• Short description of the study population:
  The study population will include all individuals registered in the data source between 1st of January 2014 and 31st of December 2023, with at least 1 year of data visibility prior to becoming eligible for study inclusion. Additional eligibility criteria will be applied for:; • Incidence rates calculation: the observation time of participants prescribed ketamine or esketamine is excluded during use and 1 year afterwards.; • Incidence rates and prevalence calculation stratified by age, sex and route of administration: age specific cohorts will have age-boundary eligibility criteria, sex specific cohorts will have sex eligibility criteria and cohort defined based on the route of administration will have route of administration eligibility criteria. ; Patient-level utilisation of ketamine and esketamine; All new users of ketamine and esketamine in the period between 1st of January 2014 and 31st of December 2023 (or latest date available). Notably, all individuals need to have at least 1 year of data visibility prior to the date of their new prescription. “New use” refers to a prescription/dispensation of ketamine or esketamine in the study period and without any use of respective medicine in the previous 1 year. ;

Study design details

• Study design:
  A cohort study will be conducted using routinely collected health data from 6 data sources.
• Main study objective:
  1. To estimate the monthly and annual incidence rate for ketamine and for esketamine prescriptions, overall and stratified by age, sex, route of administration and country/database.; 2. To estimate the monthly and annual prevalence for ketamine or esketamine prescriptions, overall and stratified by age, sex, route of administration and country/database.; 3. To characterise individuals initiating treatment with ketamine or esketamine in terms of demographics, indication for prescribing, comorbidities and concomitant medication at the treatment initiation. Results will be stratified by country/database.; 4. To estimate the initial dose at treatment initiation, treatment duration of the first drug era and cumulative duration of use for ketamine and for esketamine, where available. Results will be stratified by database. ;