Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

Phase 2 Completed 426 enrolled H. Lundbeck A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).

Timeline

Start: 2006-08
Primary completion: 2007-08
Completion: 2007-09

Outcome

Met primary endpoint

registry Placebo vs Vortioxetine 10 mg; p <0.0001; Mean Difference (Final Values) -5.70 (95% CI -8.49 to -2.91) NCT00839423 ↗

Publications

Results Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012 Jun;15(5):589-600. doi: 10.1017/S1461145711001027. Epub 2011 Jul 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venlafaxine XL	Unknown	225 mg	Oral
Subject	Vortioxetine	Unknown	5 mg	Oral
Subject	Vortioxetine	Unknown	10 mg	Oral