Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients

Phase 3 Completed 453 enrolled H. Lundbeck A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.

Timeline

Start: 2009-01
Primary completion: 2010-02
Completion: 2010-03

Outcome

Met primary endpoint

paper Lu AA21004 showed significantly (P = 0.0011) greater improvement on the primary efficacy endpoint compared with placebo at week 8 (3.3 points). PMID 22572889 ↗

Publications

Results Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):215-23. doi: 10.1097/YIC.0b013e3283542457.

Drugs

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