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

Phase 3 Completed 304 enrolled Takeda H. Lundbeck A/S · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder.

Timeline

Start: 2008-06
Primary completion: 2009-01
Completion: 2009-03

Outcome

Missed primary endpoint

registry Placebo vs Vortioxetine 5 mg; p = 0.518; LS Mean Difference 0.59 (95% CI -1.20 to 2.38) NCT00734071 ↗

paper there was no statistically significant difference in the reduction in HAM-A total score from baseline between the Vortioxetine (n=145) and placebo (n=145) groups. PMID 22901736 ↗

Publications

Results Rothschild AJ, Mahableshwarkar AR, Jacobsen P, Yan M, Sheehan DV. Vortioxetine (Lu AA21004) 5 mg in generalized anxiety disorder: results of an 8-week randomized, double-blind, placebo-controlled clinical trial in the United States. Eur Neuropsychopharmacol. 2012 Dec;22(12):858-66. doi: 10.1016/j.euroneuro.2012.07.011. Epub 2012 Aug 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vortioxetine	Unknown	5 mg	Oral