Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.

Timeline

Start

2010-06

Primary completion

2012-03

Completion

2012-03

Outcome

Mixed primary results

registry Placebo vs Vortioxetine 15 mg; p = 0.224; LS mean difference -1.5 (95% CI -3.86 to 0.91) NCT01153009 ↗

registry Placebo vs Vortioxetine 20 mg; p = 0.023; LS Mean Difference -2.8 (95% CI -5.12 to -0.38) NCT01153009 ↗

Publications

• Adair M, Christensen MC, Florea I, Loft H, Fagiolini A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26.
• Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13.
• Mahableshwarkar AR, Jacobsen PL, Chen Y, Serenko M, Trivedi MH. A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD. Psychopharmacology (Berl). 2015 Jun;232(12):2061-70. doi: 10.1007/s00213-014-3839-0. Epub 2015 Jan 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Duloxetine	Small molecule	60 mg	Oral
Subject	Vortioxetine	Unknown	15 mg	—
Subject	Vortioxetine	Unknown	20 mg	—

Indications