Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression Melancholia Mood Disorder Dysthymic Disorder Drug Therapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 836
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the long-term 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 people who have major depressive disorder (MDD). This study looked at MDD relief in people who took vortioxetine.

The study enrolled 836 patients that had completed one of two other vortioxetine studies. Participants received 5 mg of vortioxetine for the first week of treatment. After completing the first week of treatment, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day based on participant's response as judged by the doctor.

All participants were asked to take one encapsulated tablet at the same time each day throughout the study.

This multi-center trial was conducted worldwide. The overall time to participate in this study was up to 56 weeks. Participants made 13 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, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.

Interventions: intervention 1: Vortioxetine
Intervention descriptions: intervention 1: Encapsulated vortioxetine immediate-release tablets

Protocol document: