drugset / Trial / NCT01571453

Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries

NCT01571453 ↗

Phase 3 Completed 437 enrolled H. Lundbeck A/S
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).

Timeline

Start
2012-05
Primary completion
2013-10
Completion
—

Outcome

Met primary endpoint

paper non-inferiority was established with a difference of -1.2 MADRS points in favor of vortioxetine (95% CI: -3.0 to 0.6). PMID 25650503 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Venlafaxine Small molecule 150 mg —
Subject Vortioxetine Unknown 10 mg —