Vortioxetine, 5, 10, and 20 mg, Relapse Prevention Study in Adults With Major Depressive Disorder (MDD)

Summary

The purpose of this study is to evaluate the efficacy of vortioxetine (5, 10, and 20 mg) versus placebo during the first 28 weeks of the 32-week double-blind treatment period in the prevention of relapse in participants with MDD who responded to acute treatment with vortioxetine 10 mg.

Timeline

Start

2015-02-10

Primary completion

2019-03-01

Completion

2019-04-25

Outcome

Met primary endpoint

registry analysis (superiority test); Double-blind: Vortioxetine 5 mg; p = 0.006; Hazard Ratio (HR) 0.517 (95% CI 0.323 to 0.828) NCT02371980 ↗

registry analysis (superiority test); Double-blind: Vortioxetine 10 mg; p = 0.002; Hazard Ratio (HR) 0.476 (95% CI 0.296 to 0.767) NCT02371980 ↗

registry analysis (superiority test); Double-blind: Vortioxetine 20 mg; p = 0.003; Hazard Ratio (HR) 0.483 (95% CI 0.298 to 0.782) NCT02371980 ↗

paper Time to relapse was longer and cumulative relapse rates were lower for vortioxetine 5 mg (19.3%), 10 mg (17.9%), and 20 mg (17.4%) versus placebo PMID 35131363 ↗

Publications

• Thase ME, Jacobsen PL, Hanson E, Xu R, Tolkoff M, Murthy NV. Vortioxetine 5, 10, and 20 mg significantly reduces the risk of relapse compared with placebo in patients with remitted major depressive disorder: The RESET study. J Affect Disord. 2022 Apr 15;303:123-130. doi: 10.1016/j.jad.2022.02.002. Epub 2022 Feb 5.

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