Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder Depression Melancholia Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 614
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Placebo-matching capsules, orally, once daily for up to 9 weeks. arm 2: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week. arm 3: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week. arm 4: Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.

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

Protocol document: