NCT04294654

Vortioxetine in Patients With Depression and Early Dementia

Interventional, Open-label Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder and Early Dementia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression and early dementia

Conditions

• Major Depressive Disorder
• Dementia

Interventions

Type	Name	Description
DRUG	Vortioxetine	Vortioxetine 5, 10 and 20 mg/day, tablets, orally Patients will receive 5 mg vortioxetine once daily for one week. At visit 3, the dose will be increased to 10 mg/day for all patients. Thereafter the dose may be adjusted to 5, 10 or 20 mg/day.

Timeline

• Start date: 2020-02-28
• Primary completion: 2022-07-06
• Completion: 2022-07-20
• First posted: 2020-03-04
• Last updated: 2022-08-08

Locations

24 sites across 6 countries: Estonia, France, Italy, Poland, South Korea, Spain