Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

SERDOLECT

Medical condition to be studied

Schizophrenia
Population studied

Short description of the study population

Patients who received at least one prescription of sertindole recruited by psychiatrists from in- or outpatient clinics from 3 countries in order to represent different geographic regions of Europe where sertindole is being marketed: Denmark representing Northern Europe, Greece representing South-Eastern Europe and Poland representing Central Europe.

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

150
Study design details

Main study objective

The objective of the study is to check compliance of sertindole prescribers to perform ECG monitoring in real-life practice in line with sertindole SmPC requirement.

Outcomes

The number and percentage of patients with an ECG performed will be presented at different timepoints/events (as listed in the SmpC).

Data analysis plan

All assessment data will be summarised by time point and country usingdescriptive techniques. Unless otherwise specified, summary statistics (n, mean, standard deviation, median, 1st and 3rd quartiles, minimum and maximum values) will be presented for continuous variables. Counts, and if relevant, percentages, will be presented for categorical and binary variables.