Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Adults With Major Depressive Disorder

Phase 3 Completed 600 enrolled Takeda H. Lundbeck A/S · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the efficacy and safety of once daily vortioxetine (Lu AA21004) in adults with major depressive disorder.

Timeline

Start: 2008-04
Primary completion: 2008-11
Completion: 2008-11

Outcome

Missed primary endpoint

registry Placebo vs Vortioxetine; p = 0.407; LS Mean Difference -0.74 (95% CI -2.48 to 1.01) NCT00672958 ↗

paper There were no significant differences in efficacy measures between subjects in the 5 mg vortioxetine and placebo groups at week 6. PMID 22963932 ↗

Publications

Results Jain R, Mahableshwarkar AR, Jacobsen PL, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder. Int J Neuropsychopharmacol. 2013 Mar;16(2):313-21. doi: 10.1017/S1461145712000727. Epub 2012 Sep 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vortioxetine	Unknown	5 mg	Oral