Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression Drug Therapy Major Depressive Episode
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 611
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), 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 611 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 2.5 mg
* Vortioxetine 5 mg
* Duloxetine 10 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 12 weeks. Participants made 8 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Arms:
arm 1: Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. arm 3: Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsules, orally, once daily for 1 week after the treatment period. arm 4: Placebo-matching capsules, orally, once daily for up to 9 weeks.

Interventions: intervention 1: Vortioxetine intervention 2: Duloxetine intervention 3: Placebo
Intervention descriptions: intervention 1: Encapsulated vortioxetine immediate-release tablets intervention 2: Duloxetine capsules intervention 3: Placebo-matching capsules

Protocol document: