Non-interventional Cohort Study to Investigate Sertindole Prescription Management in Real-Life Practice

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  SERDOLECT
• Medical condition to be studied:
  Schizophrenia

Population studied

• Short description of the study population:
  Patients who received at least one prescription of sertindole recruited by psychiatrists from in- or outpatient clinics from 3 countries in order to represent different geographic regions of Europe where sertindole is being marketed: Denmark representing Northern Europe, Greece representing South-Eastern Europe and Poland representing Central Europe.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Schizophrenia patients
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  The objective of the study is to check compliance of sertindole prescribers to perform ECG monitoring in real-life practice in line with sertindole SmPC requirement.
• Outcomes:
  The number and percentage of patients with an ECG performed will be presented at different timepoints/events (as listed in the SmpC).
• Data analysis plan:
  All assessment data will be summarised by time point and country usingdescriptive techniques. Unless otherwise specified, summary statistics (n, mean, standard deviation, median, 1st and 3rd quartiles, minimum and maximum values) will be presented for continuous variables. Counts, and if relevant, percentages, will be presented for categorical and binary variables.