Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder

Phase 3 Completed 611 enrolled Takeda H. Lundbeck A/S · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2008-04
Primary completion: 2008-11
Completion: 2008-12

Outcome

Missed primary endpoint

paper Both doses of vortioxetine were associated with declines in HAM-D24 total scores compared to placebo but were not statistically significant. PMID 23252878 ↗

registry Placebo vs Vortioxetine 5 mg; p = 0.577; LS Mean Difference -0.58 (95% CI -2.61 to 1.46) NCT00672620 ↗

registry Placebo vs Vortioxetine 2.5 mg; p = 0.138; LS Mean Difference -1.54 (95% CI -3.58 to 0.50) NCT00672620 ↗

Publications

Results Mahableshwarkar AR, Jacobsen PL, Chen Y. A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder. Curr Med Res Opin. 2013 Mar;29(3):217-26. doi: 10.1185/03007995.2012.761600. Epub 2013 Jan 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Duloxetine	Small molecule	60 mg	Oral
Subject	Vortioxetine	Unknown	2.5 mg	Oral
Subject	Vortioxetine	Unknown	5 mg	Oral