ABILIFY for the Adolescent Bipoloar I Mania Indication of Tool Effectiveness Evaluation Strategy

Study type

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

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N05AX12) aripiprazole

  aripiprazole

Population studied

• Short description of the study population:
  Healthcare Providers (HCPs), patients and caregivers in markets where ABILIFY® has been used for the adolescent bipolar I mania indication for more than six months.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with bipolar I mania
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  1. To determine the proportion of HCPs, patients and caregivers that are aware of the RM tools and how these tools are accessed2. To determine when, how and by whom the tools are used 3. To determine the level of knowledge and comprehension of key risks
• Data analysis plan:
  Descriptive statistics for discontinuous data will be used to examine the key research questions of interest. The data for the overall population will be examined by users and non-users, general psychiatrists, child / adolescent psychiatrists, nurses, pharmacists, patients and caregivers, and individual countries. The data will be presented with responses’ frequency distributions and 95% confidence intervals