Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Drug utilisation
Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Multicentre observational study
Study drug and medical condition

Name of medicine

LATUDA

Medical condition to be studied

Schizophrenia
Population studied

Short description of the study population

Population with schizophrenia treated with lurasidone in routine clinical practice.
Inclusion criteria
1. Aged ≥18 years of age at time of initiation of lurasidone.
2. Provided consent for access to medical records for study data collection (applicable to living patients only).
3. Documented diagnosis of schizophrenia before the initiation of lurasidone.
4. Initiated on lurasidone after the 1st January 2016.
5. Judged to have capacity by their clinician to provide valid written informed consent to participate in this study.

Exclusion criteria
1. Patients whose medical records were unavailable for review.
2. Patients who participated in a clinical trial of an investigational medicinal product during the post-index observation period.

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)

Special population of interest

Other

Special population of interest, other

Schizophrenia patients

Estimated number of subjects

80
Study design details

Main study objective

To describe the dose titration process, dosing regimens, treatment duration and reasons for discontinuation following initiation of lurasidone in adult patients with schizophrenia.

Outcomes

Summary measures of lurasidone treatment duration i.e. Proportion of patients taking treatment for full 12 months, Summary measures of baseline demographics and clinical characteristics Summary measures of treatment history for schizophrenia Dose distribution of lurasidone prescribed and summary measures of dose regimen Time until first relapse following lurasidone initiation Adverse events following lurasidone initiation Summary measures of healthcare resource utilisation

Data analysis plan

All primary endpoint (and secondary endpoint) analyses will be descriptive in nature. For continuous variables (such as duration of time with disease) the mean, standard deviation, median, interquartile range and range will be calculated. For nominal variables, frequencies and proportions in the form of percentages will be calculated for each group. For investigating changes in weight, blood glucose, lipid levels and liver function from baseline at 3,6,9 and 12 months following initiation of lurasidone, changes will be described using summary measures as described for continuous variables above for each time, they will then be compared using a paired t-test (or Wilcoxon signed rank test if distributions are non-normal), although based upon a previous study of changes in weight(10) as a result of treatment change, it is expected that any change will be too small to detect a significant change with feasible sample size for the study.