A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder

Summary

The main aim of the study is to check how well vortioxetine 10 mg/day or 20 mg/day works and to check for side effects compared to a placebo on depression symptoms in Japanese teenagers aged 12 to 17 years with a diagnosis of Major Depressive Disorder (MDD). The overall time each participant will be in the study is about 20 weeks. This includes up to 15 days (about 2 weeks) to check who can take part, a 14-week period where everyone receives vortioxetine or a placebo, and after that, a 4-week period to check for any side effects after treatment. During the study, participants will visit their clinic 13 times.

Timeline

Start

2025-10-01

Primary completion

2029-09-30

Completion

2029-09-30

Drugs

Indications