A phase IV, non-­interventional, post-­marketing registry study on the use of Tracydal® (tranylcypromine) for the treatment of treatment-­resistant depression in the Netherlands

Study type

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

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Name of medicine, other:
  Tracydal
• Medical condition to be studied:
  Depression

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  229

Study design details

• Main study objective:
  To assess the effectiveness of risk minimisation measures for Tracydal® and to monitor the use of tranylcypromine for the treatment of treatment-resistant depression in the Netherlands.
• Outcomes:
  The primary endpoint is the number of occurrences recorded that would indicate non-regard to the educational material provided to patients. This is the incidence of preventable adverse drug events related to the important identified risks as identified in the RMP, the risk being hypertensive crisis. The secondary endpoints are:1. Overall occurrence of adverse drug events2. Percentage change in the value of severity of depression scale and response based upon the validated response criteria for the rating scale utilized. 3. Percentage change in the value of social functioning scale and response based upon the validated response criteria for the rating scale utilized.
• Data analysis plan:
  All data will be presented in terms of descriptive statistics and presented in tabular format. Exploratory analysis will be focusing on Spearman Correlations analysis to be able to determine whether any factors have a significant correlation with the frequency of adverse events, evaluations based on depression or social functioning scales. Factors to be analysed will be described and listed in the statistical analysis plan.