An Observational Post-Authorisation Safety Specialist Cohort Monitoring Study (SCEM) to Monitor the Safety and Utilisation of Asenapine (Sycrest) in the Mental Health Trust Setting in England (OBSERVA)

Study type

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

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Intensive monitoring schemes

Study drug and medical condition

• Name of medicine:
  SYCREST

Population studied

• Short description of the study population:
  Patients who present to psychiatrists within the standard course of care as in- or out-patients for treatment of a clinical diagnosis of a mental health disorder which requires pharmacological treatment with an atypical antipsychotic. Patients started on asenapine (Sycrest) were included.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To monitor the short-term (12 weeks) use and safety of asenapine prescribed to asenapine naïve (new user) patients for the treatment of moderate to severe manic episodes associated with bipolar I disorder, and other psychiatric disorders by psychiatrists under normal conditions of use in the mental health care trust setting.
• Outcomes:
  To provide timely information on:1. Accrual of psychiatrists2. Cohort accrual, the type of clinician responsible for, and the setting of initiation of treatment.3. To quantify the incidence rate of selected important identified and potential risks which are:a) Somnolence and sedation b) Weight gain c) Oral hypoaesthesia d) Swelling of the tongue and throat e) Allergic reactions, 1. To provide timely information on the baseline health profile of patients prescribed asenapine in the mental health care trust and the treatment programme they received 2. To describe the risk profile of events reported in the 12 week observation period in patient subgroups of special interest3. To describe clinical features and management of cases of suicide/ self injury
• Data analysis plan:
  Data analysis will include• Response rates to describe recruitment• Hazard rates to explore the incidence of selected events• Descriptive analyses of baseline health profile of patients• Analysis of risk and incidence densities to describe the risk profile of events reported in patient subgroups of special interest