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

Cross-sectional
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

LURASIDONE

Medical condition to be studied

Schizophrenia
Population studied

Age groups

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
Pregnant women
Renal impaired

Estimated number of subjects

6611
Study design details

Main study objective

The overall aim of this research is to characterise the safety profile of lurasidone compared other second generation antipsychotics in clinical practice

Data analysis plan

Drug Utilisation Study: Descriptive statistics, including means (SD) and medians (10th to 90th percentiles) for continuous variables, and numbers and percentages for categorical variables will be used to examine the following characteristics in new users of lurasidone compared with all other second generation antipsychotic drugs combined: demographics, comorbidities and comedications, pattern of onset, dose adjustment, and duration of therapy, prevalence ofa schizophrenia diagnosis, and prevalence of other relevant psychiatric indications in the absence of a schizophrenia diagnosis. Numbers of patients censored from the study by calendar year, and length of follow-up by year of therapy initiation will be reported.PASS: Exposure propensity scores will be used to frequency match new users of lurasidone with new users of comparator second generation antipsychotics. Patients will also be matched on age and gender.