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

Summary

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

Timeline

Start

2010-08

Primary completion

2012-05

Completion

2012-06

Outcome

Missed primary endpoint

paper Differences from placebo in the primary efficacy end point were not statistically significant for vortioxetine 10 mg or vortioxetine 15 mg. PMID 26035186 ↗

Publications

• Mahableshwarkar AR, Jacobsen PL, Serenko M, Chen Y, Trivedi MH. A randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 doses of vortioxetine in adults with major depressive disorder. J Clin Psychiatry. 2015 May;76(5):583-91. doi: 10.4088/JCP.14m09337.

Drugs

Indications