NCT03766867

Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression

Interventional, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Initial Administration of 25 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day for 7 days

Detailed description

The study consists of a 7-day double-blind Treatment Period (Day 0 to Day 6)

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Vortioxetine infusion 25 mg	1 mg/mL, concentrate for solution for infusion, 25 mL (25 mg) administered in 250 mL saline over 2 hours as single dose for 7 days
DRUG	Vortioxetine tablets 10 mg/day	10 mg, tablets, oral administration once daily
DRUG	Placebo infusion	concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose
DRUG	Placebo tablets	oral administration once daily

Timeline

• Start date: 2018-12-03
• Primary completion: 2019-07-31
• Completion: 2019-08-28
• First posted: 2018-12-06
• Last updated: 2019-08-29

Locations

13 sites across 3 countries: Bulgaria, Estonia, Latvia