NCT03555136

Real-life Effectiveness of Vortioxetine in Depression

Real-life Effectiveness of Vortioxetine in Patients With Major Depressive Disorder: Non-interventional, Multi-national, Prospective Cohort Study to Assess Real-life Effectiveness of Vortioxetine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 992 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences. Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice. The study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life. This is an observational, multi-national, study in patients with MDD initiating treatment with vortioxetine. Information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). This study will be conducted in six countries. In total 2,100 patients are planned for enrolment.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Vortioxetine	Treatment with vortioxetine as per local SmPC

Timeline

• Start date: 2017-11-17
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2018-06-13
• Last updated: 2021-05-27

Locations

106 sites across 4 countries: United States, Canada, France, Italy

Regulatory

• FDA-regulated drug study