A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD.

ABSTRACT:

Rationale

Vortioxetine has reduced depressive symptoms in adults with major depressive disorder (MDD) in multiple clinical trials.

Objectives

The aim of this study is to evaluate the efficacy, safety, and tolerability of vortioxetine 15 and 20 mg vs placebo in adults with MDD.

Methods

Patients were randomized 1:1:1:1 to vortioxetine 15 mg, vortioxetine 20 mg, duloxetine 60 mg (active reference), or placebo. The primary efficacy endpoint was mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 8 (MMRM). Safety/tolerability assessments included physical examinations, vital signs, laboratory evaluations, electrocardiograms, adverse events (AEs), Columbia-Suicide Severity Rating Scale, Arizona Sexual Experiences Scale, and Discontinuation-E

SUBMITTER: Mahableshwarkar AR 

PROVIDER: S-EPMC4432084 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature