NCT04448431

Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression

A Randomised, Double-blind, Parallel-group, Active Controlled Study Evaluating the Efficacy of Vortioxetine Versus Desvenlafaxine in Adult Patients Suffering From Major Depressive Disorder With Partial Response to SSRI Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 605 (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 compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit

Detailed description

The study will consist of a screening period of up to 14 days before the Baseline Visit, followed by an 8-week Treatment Period with vortioxetine or desvenlafaxine. A Safety Follow-up Visit will be performed approximately 4 weeks after the Primary Outcome/Withdrawal Visit. At Baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an 8-week, double-blind Treatment Period.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Vortioxetine	10 or 20 mg/day, capsules, orally
DRUG	Desvenlafaxine	50 mg/day capsules, orally

Timeline

• Start date: 2020-06-18
• Primary completion: 2022-01-06
• Completion: 2022-02-04
• First posted: 2020-06-25
• Last updated: 2022-02-14

Locations

80 sites across 12 countries: Argentina, Belgium, Bulgaria, Czechia, Estonia, Latvia, Mexico, Russia, Slovakia, Spain, Sweden, Ukraine