Study identification

EU PAS number

EUPAS17678

Study ID

30635

Official title and acronym

Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures

DARWIN EU® study

No

Study countries

Denmark
France
Germany
Spain

Study description

Non-interventional, multinational Post-Autorisation Safety Study in patients initiating agomelatine treatment in routine clinical practice in Denmark, France, Germany, and Spain. The study includes a retrospective medical data abstraction to collect patient data before and after the last minimization measures in order to evaluate adherence to the liver test monitoring regimen and compliance with relevant contraindications and a cross-sectional patient survey to assess patients’ reasons for non-compliance with the liver test monitoring regimen. Medical data abstraction will collect characteristics of agomelatine users including relevant comorbidities, date, dose, and duration of agomelatine prescriptions and of fluvoxamine and/or ciprofloxacin, date of liver function tests (ALT and AST) and results. The patient survey will collect patients’ characteristics, knowledge of the key liver safety information, and reasons for non-compliance with liver test monitoring when applicable.

Study status

Finalised
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
Multiple centres: 51 centres are involved in the study

Contact details

Lynne Hamm

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

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

More details on funding

Institut de Recherches Internationales Servier
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)