A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder (NCT07204314) | Clinical Trial Compass
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Japan180 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The Japanese participant is a male or female, aged 12 to 17 years at the time of informed consent (patients who turn 18 years during the trial will be allowed to continue in the trial).
. The participant is capable of communicating with the site personnel.
. The participant is able to understand the informed assent form or the ICF and parent(s)/legal guardian(s) are able to read and understand the ICF. The participant is able and willing to accept video recording at the assessment by the trial site and evaluation by third party evaluators (Central Evaluating Committee).
. The participant has provided the written informed assent as much as possible to participation and parent(s)/legal guardian(s) signed the ICF.
. The participant and parent(s)/legal guardian(s) are willing and able to attend trial appointments within the specified time windows.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing vortioxetine specifically in Japanese pediatric patients with major depressive disorder — does my child's background, age, or specific diagnosis make them a potential candidate worth discussing with you?
2Since this is a Phase 3 trial, what does that mean for how much is already known about vortioxetine's safety and effectiveness in children, and are there any risks specific to using this medication in pediatric patients that we should talk through?
3The trial measures improvement using something called the CDRS-R scale — can you explain what that scale tracks, and how meaningful a change in that score would be for my child's day-to-day life?
4Before considering a trial like this, should we discuss whether any currently approved treatments for pediatric depression might be a better first step for my child?
5If my child were to participate, what would the visit schedule and monitoring look like, and how might the demands of the trial fit into our family's daily routine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in the Children Depression Rating Scale Revised version (CDRS-R) Total Score
. The participant is an outpatient consulting a clinician.
. The participant has a primary diagnosis of MDD or persistent depressive disorder and fully meet the criteria for major depressive episodes according to DSM-5-TR without psychotic features although co-morbid anxiety disorders will be permitted. The diagnoses will be confirmed using the MINI-KID.
. The participant has a CDRS-R total score greater than or equal to 45 at the Screening Visit and at the Baseline A Visit (Week 0).
Exclusion criteria
. The participant has previously been entered and moved to Phase A in this trial.
. The participant has participated in a clinical trial less than 30 days before the Screening Visit.
. The participant is a member of the trial personnel or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the trial personnel.
. The participant has been previously treated with vortioxetine.
. The participant has the current or previous major depressive episode which was considered by the investigators to have been resistant to 2 or more adequate antidepressants treatments of at least 6-weeks duration each at sufficient doses.
. The participant is under forced treatment.
. The participant has experienced any environmental change (eg, hospitalization, change of residence) considered by the investigator to have the potential impact on the participant's disease situation or plans such environmental changes during the trial.