An Observational Drug Utilization Study of SYCREST® (asenapine) in the United Kingdom (P08308)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  SYCREST
• Medical condition to be studied:
  Bipolar disorder

  Schizophrenia

Population studied

• Short description of the study population:
  Patients prescribed asenapine or any other comparator (olanzapine, quetiapine, ziprasidone, iloperidone, risperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole, zotepine or aripiprazole) as recorded in CPRD UK and meet following criteria-; 1) >1 prescription for asenapine or any comparator within the study period; 2) Age 18+ at the time the patient receives a prescription for the comparator; 3) Date of prescription for asenapine or any comparator occurs after the patient registration date or the database specific quality indicator date; 4) A minimum of >365 days of evaluable baseline observation time, occurring prior to the date of prescription for asenapine or any comparator.
• Age groups:
  • Paediatric Population (< 18 years)

    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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:
  Patients with schizophrenia, bipolar disorder or any other psychotic disorder
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  1. Describe baseline demographic characteristics, clinical characteristics and healthcare utilization among new users of asenapine aged 18+ years 2. Identify and describe a recent-historical, matched aripiprazole cohort in general practice among patients aged 18+ years, to put asenapine use into context3. Describe off-label use of asenapine in general practice among patients aged 0-17 years
• Outcomes:
  1. Frequency and proportion of use, by psychiatric diagnosis, among new users of asenapine and aripiprazole aged 18+ years in the CPRD and THIN databases2. Frequency and proportion of pediatric use, by psychiatric diagnosis, among asenapine users in the CPRD and THIN databases3. Demographic, clinical characteristics and healthcare utilization among new users of asenapine and aripiprazole
• Data analysis plan:
  All analyses for this drug utilization study will be descriptive. No statistical hypothesis testing will be conducted in this observational study. The frequency and proportions of on- and off-label use will be described.An epidemiology Safety Review Committee comprised of independent clinicians and experts will perform integrated review of the findings of the study, and evaluate the safety data that emerge from the study using both clinical judgment and pre-specified statistical criteria as guidelines.