Use of Low-dose Quetiapine and the Risk of Major Adverse Cardiovascular Events

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43842
• EU PAS number:
  EUPAS38508
• Study ID:
  43842
• Official title and acronym:
  Use of Low-dose Quetiapine and the Risk of Major Adverse Cardiovascular Events
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  Quetiapine is frequently used off-label in low-doses for its anxiolytic-hypnotic properties. Quetiapine has been associated with both metabolic disturbances and cardiac arrhythmias, when used in high doses for treatment of severe mental illness, but it is not known whether the use of low doses is associated with an increased risk of major adverse cardiovascular events (MACE). The study is a new-user, active-comparator cohort study which aims to assess the association between the use of low-dose quetiapine and the risk of MACE using Danish health registers.
• Study status:
  Planned

Research institution and networks

Institutions

University of Southern Denmark (SDU)

Denmark

Study timelines

Date when funding contract was signed

Planned: 30/11/2018

Study start date

Planned: 01/12/2020

Data analysis start date

Planned: 18/01/2021

Actual: 01/06/2021

Date of final study report

Planned: 01/10/2021

Sources of funding

Other

More details on funding

Psychiatric Research Fund Region of Southern Denmark

Study protocol

Initial protocol

Quetiapine_CVD_protocol_180121

Updated protocol

quetiapine_cvd_protocol_27oct21

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable