RecruitingPhase 3NCT07204314

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)

Sponsor

Takeda

Enrollment

180 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vortioxetine — an antidepressant already used in adults — is safe and effective for Japanese teenagers aged 12–17 with major depression. The study aims to fill an important gap, as most antidepressants have been tested mainly in adults. **You may be eligible if...** - You are a Japanese patient aged 12–17 (those who turn 18 during the trial may continue) - You have been diagnosed with major depressive disorder (MDD) or a major depressive episode based on standard criteria - You are currently an outpatient seeing a doctor for this condition - Your depression severity scores meet the required thresholds at both the screening and baseline visits - Your parent or guardian has provided written consent **You may NOT be eligible if...** - You have psychotic symptoms (like hallucinations or delusions) along with your depression - You have used certain antidepressants or other medications that interact with vortioxetine - You have serious physical health conditions - You are unable to attend required appointments within the specified timeframes - You are unable to give consent (or your guardian is unable to) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVortioxetine tablets

Vortioxetine tablets

DRUGPlacebo tablets

Placebo tablets

Locations(30)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Kaku Mental Clinic

Chūōku, Fukuoka, Japan

Jisenkai Nanko Psychiatric Institute

Shirakawa, Fukushima, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

NHO Shikoku Medical Center for Children and Adults

Zentsujichó, Kagawa-ken, Japan

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Kanagawa Children's Medical Center

Yokohama, Kanagawa, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Kochi Medical School Hospital

Nankoku, Kochi, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Miyakonojo Shinsei Hospital

Miyakonojō, Miyazaki, Japan

Nara Medical University Hospital

Kashihara, Nara, Japan

Bandai Mental Clinic

Chuo-ku, Niigata, Japan

University of the Ryukyus Hospital

Ginowan, Okinawa, Japan

Imurokokorono-clinic

Urasoe, Okinawa, Japan

Kindai University Hospital

Ōsaka-sayama, Osaka, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, Japan

Harai Clinic

Chuo-ku, Tokyo, Japan

Tokyo Metropolitan Children's Medical Center

Fuchū, Tokyo, Japan

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Aiiku Clinic

Minato-ku, Tokyo, Japan

Pauroom

Minato-ku, Tokyo, Japan

Kai Kokoro Clinic

Suginome, Tokyo, Japan

Shin-Otsuka Clinic

Toshima-ku, Tokyo, Japan

Cerisier Heart Clinic

Kagoshima, Japan

Yuge Neuropsychiatric Hospital

Kumamoto, Japan

Chikama Clinic

Miyazaki, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Toyama University Hospital

Toyama, Japan

View Full Details on ClinicalTrials.gov

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NCT07204314

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