Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07204314 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 3
SponsorTakeda
Started2025-10-01
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 6 times since 2025-09-30; most recent filed 2026-08-04. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-08-04
Amendment Study Status, Contacts/Locations v6
2026-05-21
Amendment Study Status, Contacts/Locations v5
2026-03-10
Amendment Study Status, Contacts/Locations v4
2026-02-12
Amendment Study Status, Contacts/Locations v3
2025-12-11
Amendment Study Status, Contacts/Locations v2
2025-11-13
Amendment Not Yet RecruitingRecruiting Study Identification, Study Status, Contacts/Locations, References v1
2025-09-30
Original filing
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 2026-09-02