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

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with major depressive disorder. The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive disorder.

Timeline

Start

2011-05

Primary completion

2012-12

Completion

2012-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Vortioxetine 5 mg vs Placebo; p = 0.1031; Least square means difference -2.03 (95% CI -4.467 to 0.413); ANCOVA NCT01355081 ↗

registry analysis (superiority or other test); Vortioxetine 10 mg vs Placebo; p = 0.4008; Least square mean difference -1.04 (95% CI -3.461 to 1.387); ANCOVA NCT01355081 ↗

paper Vortioxetine failed to meet significance versus placebo in the primary efficacy analysis at week 8 in the short-term study. PMID 29160598 ↗

Publications

• Inoue T, Nishimura A, Sasai K, Kitagawa T. Randomized, 8-week, double-blind, placebo-controlled trial of vortioxetine in Japanese adults with major depressive disorder, followed by a 52-week open-label extension trial. Psychiatry Clin Neurosci. 2018 Feb;72(2):103-115. doi: 10.1111/pcn.12623. Epub 2017 Dec 27.

Drugs

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

Indications