Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

Summary

The purpose of this study is to assess the efficacy and safety of multiple doses of vortioxetine, once daily (QD), in participants with major depressive disorder.

Timeline

Start

2010-11

Primary completion

2012-03

Completion

2012-04

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Vortioxetine 5 mg; p = 0.9070; LS Mean Difference -0.61 (95% CI -3.258 to 2.035); ANCOVA NCT01255787 ↗

paper Vortioxetine failed to show significant differences from placebo in the primary end-point. PMID 28858412 ↗

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.
• Nishimura A, Aritomi Y, Sasai K, Kitagawa T, Mahableshwarkar AR. Randomized, double-blind, placebo-controlled 8-week trial of the efficacy, safety, and tolerability of 5, 10, and 20 mg/day vortioxetine in adults with major depressive disorder. Psychiatry Clin Neurosci. 2018 Feb;72(2):64-72. doi: 10.1111/pcn.12565. Epub 2017 Oct 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vortioxetine	Unknown	5 mg	Oral
Subject	Vortioxetine	Unknown	10 mg	Oral
Subject	Vortioxetine	Unknown	20 mg	Oral

Indications