Extrapyramidal symptoms in patients treated with Abilify Maintena®: Cohort study with a 2-year follow-up using European automated healthcare databases

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  1500

Study design details

• Main study objective:
  Aims of this study are to further assess the risk of EPS-related events linked to the use of Abilify Maintena®, in routine clinical practice.
• Data analysis plan:
  In this non-comparative study, only descriptive statistics will be used. Summary statistics (mean, standard deviation, median, inter-quartile range, minimum and maximum values) will be presented for continuous variables. Counts and percentages will be presented for categorical and binary variables. In addition, an analysis on time to EPS onset will be performed using Kaplan-Meier estimator of survival function and Cox proportional hazards regression models.