Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder Depression Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 469
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 469 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 10 mg
* Vortioxetine 15 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 14 weeks. Participants made 7 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 placebo-matching capsules, orally, once daily for up to 8 weeks. arm 2: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks. arm 3: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.

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

Protocol document: