Study identification

EU PAS number

EUPAS1000000594

Study ID

1000000594

Official title and acronym

Retrospective, non-interventional multicenter study on the effect of QUVIVIQ in patients with insomnia disorder with comorbid anxiety and/or depression disorders

DARWIN EU® study

No

Study countries

Germany
Italy
Spain
United Kingdom

Study description

Study design
This is a multi-centre, retrospective, non-interventional study in patients treated with QUVIVIQ. Data will be collected retrospectively using only existing patient data found in medical records.

Research question
Is QUVIVIQ safe and efficacious in patients with insomnia disorder and comorbid anxiety and/or depression disorders in clinical practice?

Main objective
To describe the safety and efficacy of QUVIVIQ in patients with insomnia disorder and comorbid anxiety and/or depression in a real-world setting.

Data sources
Patient data will be collected from existing medical records by the participating sites, i.e., medical charts / electronic medical records, including patient self-reports/surveys, tests, and assessments.

Recruitment strategy
The investigators involved in the study will inform their eligible patients of the study and request consent for data collection.

Study status

Ongoing
Research institutions and networks

Institutions

Idorsia Pharmaceuticals Ltd

Contact details

Idorsia Clinical Trial Information

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Idorsia Pharmaceuticals Ltd
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable