Study identification

EU PAS number

EUPAS28735

Study ID

46673

Official title and acronym

An observational, real world evidence study to describe clinical experience with lurasidone in the treatment of adult patients with schizophrenia in routine clinical practice in Europe (LATUDA)

DARWIN EU® study

No

Study countries

Netherlands
Switzerland
United Kingdom

Study description

This is an international, multi-centre observational, real world evidence study. This study will be conducted in 4 to 8 mental health centres in the United Kingdom (UK), Netherlands and Switzerland. The study is based on both retrospective and prospective collection of data from patients’ medical records. It is a single group study without a comparator, to reflect real world clinical practice. There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required. The population for this study is adult patients diagnosed with schizophrenia who received treatment with a medicine called lurasidone as part of their standard clinical care. It is expected to recruit 80 patients in total. The main purpose is to find out more about how lurasidone is used to treat patients with schizophrenia in the real world and how well it works.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 7 centres are involved in the study

Contact details

Matthew Sargeant

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

CNX Therapeutics Ltd (formerly Sunovion Pharmaceuticals Ltd)
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable