NCT02919501

Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder

Interventional, Randomised, Double-blind, Parallel-group Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and vortioxetine 10 mg/day oral dose regimen versus placebo IV and vortioxetine 10 mg/day oral dose regimen on depressive symptoms

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Vortioxetine (IV)	17 mg, solution for infusion, administered, over 2 hours as single dose
OTHER	Placebo (IV)	Saline: isotonic sodium chloride, administered, over 2 hours as single dose
DRUG	Vortioxetine (tablet)	10 mg, tablets, oral administration once daily for 15 days (open labelled)

Timeline

• Start date: 2016-09-27
• Primary completion: 2017-04-27
• Completion: 2017-04-27
• First posted: 2016-09-29
• Last updated: 2018-06-20

Locations

7 sites across 2 countries: Estonia, Finland