NCT07204314

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

A Randomized, Double-blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once-Daily Oral Administration of Vortioxetine in Japanese Pediatric Patients 12 to 17 Years of Age With Major Depressive Disorder (MDD)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Vortioxetine tablets	Vortioxetine tablets
DRUG	Placebo tablets	Placebo tablets

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-09-30
• Completion: 2029-09-30
• First posted: 2025-10-02
• Last updated: 2026-03-11

Locations

30 sites across 1 country: Japan