Conditions: Major Depressive Disorder
Keywords: Depression Depressive Disorder Mood Disorder Mental Disorder Melancholia, Involutional Paraphrenia, Involutional Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 560
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients 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 560 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 1 mg
* Vortioxetine 5 mg
* Vortioxetine 10 mg
* Placebo (dummy inactive pill) - 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-centre trial was conducted in Europe, Asia, Australia, and South Africa. 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 1 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 3: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 4: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.

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

Protocol document: