An Observational Post-Authorization Safety Surveillance (PASS) Study of SYCREST® (asenapine) among Patients aged 18 and older Diagnosed with Bipolar Disorder (P08307)

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

• Study drug International non-proprietary name (INN) or common name:
  ASENAPINE
• Medical condition to be studied:
  Bipolar disorder

  Schizophrenia

Population studied

• Short description of the study population:
  Patients treated with asenapine were identified within the Bipolar Disorder cohort identified from CPRD.; 1) First written prescription for asenapine after entry into the Bipolar Disorder cohort or first written prescription for asenapine within 2 years before entry into the Bipolar Disorder cohort (treatment before diagnosis). In CPRD, among patients receiving a prescription of olanzapine and / or risperidone prior to their diagnosis (i.e., patients receiving treatment before diagnosis), the cumulative distribution shows approximately 70% have a duration of time between initiation of treatment and first diagnosis of Bipolar Disorder within 2 years. ; 2) No use of asenapine within 365 days prior to the first written prescription for asenapine defined above ; 3) ≥ 365 days of time accumulated between asenapine prescription date and the latter of either (a) the registration date with the general practitioner or (b) the database specific quality indicator date
• 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:
  Patients with schizophrenia, bipolar disorder or any other psychotic disorder
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  To describe baseline demographic & clinical characteristics, to assess the incidence rates of identified & potential risks in bipolar disorder patients (aged 18+) newly prescribed asenapine, and to compare the incidence rates if adequate study power is achieved for asenapine users relative to two comparison cohorts (risperidone and olanzapine).
• Outcomes:
  The identified and potential risks among bipolar disorder patients age 18+ prescribed asenapine. The identified risks include extrapyramidal symptoms, somnolence and sedation, neuroleptic malignant syndrome, seizure, hyperprolactinaemia, orthostatic hypotension, allergic reactions, dyslipidaemia and diabetes mellitus. The potential risks include rhabdomyolysis and neutropenia. The same list of identified and potential risks as those in the primary outcomes among patients age 18+ prescribed asenapine for schizophrenia and other diagnoses excluding bipolar disorder.
• Data analysis plan:
  Baseline characteristics will be described for new users of the study drugs of interest.Incidence rates for each risk will be calculated among bipolar disorder patients aged 18+ prescribed asenapine.If pre-specified study power levels are achieved comparison of the identified and potential risks between asenapine and other two comparison cohorts (risperidone and olanzapine) will be performed.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.