DARWIN EU® - Capturing suicidality and depression related variables in databases

Study identification

• EU PAS number:
  EUPAS1000000825
• Study ID:
  1000000825
• Official title and acronym:
  DARWIN EU® - Capturing suicidality and depression related variables in databases
• DARWIN EU® study:
  Yes
• Study countries:
  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Netherlands

  Norway

  Portugal

  Spain

  Sweden

  United Kingdom
• Study description:
  Depression is a prevalent health condition causing significant healthcare utilisation, morbidity, and mortality. Self-harm, suicidal ideation, attempt, and suicide also comprise a complex and significant public health issue. Safety concerns on the use of medicines in these populations or medicines as a cause of these conditions are increasingly common. A better understanding on how well data on these areas are captured will be important to inform the feasibility of conducting Real world data (RWD) studies on these populations or their use as outcomes in DARWIN EU® studies.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Department of Medical Informatics - Health Data Science, Erasmus Medical Center (ErasmusMC)

Netherlands

Networks

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Belgium

Croatia

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Italy

Netherlands

Norway

Portugal

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned:31/08/2025

Actual:31/08/2025

Study start date

Planned:12/12/2025

Actual:12/12/2025

Date of final study report

Planned:01/09/2026

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable