Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

Summary

The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Timeline

Start

2008-06

Primary completion

2009-01

Completion

2009-02

Outcome

Missed primary endpoint

paper Neither vortioxetine dose achieved a statistically significant improvement over placebo on the primary endpoint PMID 24424707 ↗

registry Placebo vs Vortioxetine 2.5 mg; p = 0.279; LS Mean Difference -0.87 NCT00731120 ↗

registry Placebo vs Vortioxetine 10 mg; p = 0.306; LS Mean Difference -0.81 NCT00731120 ↗

Publications

• Mahableshwarkar AR, Jacobsen PL, Serenko M, Chen Y. A randomized, double-blind, fixed-dose study comparing the efficacy and tolerability of vortioxetine 2.5 and 10 mg in acute treatment of adults with generalized anxiety disorder. Hum Psychopharmacol. 2014 Jan;29(1):64-72. doi: 10.1002/hup.2371.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vortioxetine	Unknown	2.5 mg	Oral
Subject	Vortioxetine	Unknown	10 mg	Oral

Indications