Vortioxetine (Lu AA21004) 10 and 20 mg for Treatment of Major Depressive Disorder With Sexual Dysfunction

Summary

The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily (QD), compared with escitalopram on sexual functioning.

Timeline

Start

2011-06

Primary completion

2013-12

Completion

2013-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Vortioxetine vs Escitalopram; p = 0.013; LS mean difference 2.2 (95% CI 0.48 to 4.02); Mixed Model Repeated Measurements NCT01364649 ↗

release “patients who were well treated for MDD but experienced treatment-emergent sexual dysfunction showed significant improvement in sexual function with Brintellix vs. escitalopram” takeda.com ↗

Publications

• Jacobsen PL, Nomikos GG, Zhong W, Cutler AJ, Affinito J, Clayton A. Clinical implications of directly switching antidepressants in well-treated depressed patients with treatment-emergent sexual dysfunction: a comparison between vortioxetine and escitalopram. CNS Spectr. 2020 Feb;25(1):50-63. doi: 10.1017/S1092852919000750.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Escitalopram	Small molecule	10 mg	Oral
Comparator	Escitalopram	Small molecule	20 mg	Oral
Subject	Vortioxetine	Unknown	10 mg	Oral
Subject	Vortioxetine	Unknown	20 mg	Oral

Indications

No indication recorded.