Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07204314
Lead Sponsor Takeda
Conditions Major Depressive Disorder
Enrollment 180 participants
Start Date 2025-10-01
Primary Completion 2029-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-22