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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 29, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT07204314). This is a study registration, not published results. Lead sponsor: Takeda. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 180 participants (ESTIMATED). Conditions: Major Depressive Disorder. Interventions: DRUG: Vortioxetine tablets; DRUG: Placebo tablets. Primary outcome measures: Change from Baseline in the Children Depression Rating Scale Revised version (CDRS-R) Total Score , Baseline, Week 14. Brief 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.