NCT01153009

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

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (15 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 614 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine. The study enrolled 614 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Vortioxetine 15 mg * Vortioxetine 20 mg * Duloxetine 60 mg * Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug but had no active ingredient. All participants were asked to take one capsule at the same time each day throughout the study. This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 13 weeks. Participants made 9 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Vortioxetine	Encapsulated vortioxetine immediate release tablets
DRUG	Duloxetine	Overencapsulated duloxetine delayed-release capsules
DRUG	Placebo	Placebo-matching capsules

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-06-29
• Last updated: 2013-12-18
• Results posted: 2013-12-18

Locations

56 sites across 1 country: United States