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Major Depressive DisorderPhase 3NCT07204314

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

A Phase 3 study testing Vortioxetine tablets in people with Major Depressive Disorder, run by Takeda at 30 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Vortioxetine tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
30 sitesJapan
Study dates
1 Oct 2025to 30 Sep 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
  • The participant is an outpatient consulting a clinician.
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  • 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).
  • The participant has a CGI-S score greater than or equal to4 at the Screening Visit and at the Baseline A Visit (Week 0).
  • The participant has a PHQ-A score of greater than or equal to10 at the Baseline A Visit (Week 0).
  • The participant, if a female and is capable of producing viable ova, agrees to the following, for the period from the signing of ICF until 30 days after the last dose of trial intervention.
  • To use a highly effective or acceptable contraceptive method
  • To avoid donating ova
  • The participant, if a female, must have a confirmed negative urine pregnancy test at the Screening Visit

Who cannot join

  • 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.
Show all 35Show fewer
  • 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.
  • The participant is pregnant or breast-feeding.
  • The participant receives on-going psychotherapy (except for a supportive psychotherapy) that is started less than 3 months before the Baseline A Visit (Week 0) and/or that is planned to be intensified during the trial.
  • The participant has a history of severe drug allergy or hypersensitivity or known hypersensitivity to any of the IMPs or their excipients.
  • The participant has hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltose insufficiency.
  • The participant has any current psychiatric disorder, including posttraumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), autism spectrum disorder (ASD), and attention-deficit/hyperactivity disorder (ADHD) as assessed using the MINI-KID. If the MINI-KID screening assessment suggests the presence of any current psychiatric disorders other than permitted co-morbid anxiety disorders, the participant may be enrolled only if an additional evaluation confirms that the participant does not meet DSM-5-TR criteria for that disorder at Screening, as determined by the investigator.
  • The participant has a medical history of substance use disorder (excluding nicotine, and caffeine) or alcohol use disorder (DSM-5-TR criteria) less than 6 months before the Screening Visit.
  • The participant has reported current use of or has tested positive for drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, benzodiazepines, and cannabinoids, etc).
  • The participant suffers from medical, organic or drug cause mental disorders (DSM-5-TR criteria).
  • The participant has a known intellectual disability; or clinical evidence or known social or school history indicative of intellectual disability.
  • The participant has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with trial treatment or impair treatment compliance.
  • The participant has a history of moderate or severe head trauma; or other neurological disorders or systemic medical diseases that are, in the investigator's opinion, likely to affect central nervous system functioning.
  • The participant has a known first degree relative with a history of bipolar disorder.
  • The participant is unable to swallow tablets.
  • The participant has a history of cancer that has not been in remission for more than 5 years before the first dose of trial intervention.
  • The participant has or has had 1 or more of the following conditions that is/are considered clinically relevant in the context of the trial: neurological disorder, other psychiatric disorder, cardiovascular disease, seizure disorder or encephalopathy, congestive heart failure, cardiac hypertrophy, arrhythmia, bradycardia (pulse less than 50 bpm), respiratory disease, hepatic impairment or renal insufficiency, metabolic disorder, endocrinological disorder, gastrointestinal disorder, hematological disorder, infectious disorder, any clinically significant immunological condition, dermatological disorder, venereal disease, congenital or juvenile glaucoma or is at risk of acute narrow-angle glaucoma
  • The participant takes or has taken disallowed recent or concomitant medication, or it is anticipated that the participant will require treatment with at least one of the disallowed concomitant medications/procedures or treatment during the trial.
  • The participant has clinically significant abnormal vital signs at the Screening Visit.
  • The participant has 1 or more clinical laboratory test values outside the reference range, based on the blood and urine samples taken at the Screening Visit, which are of potential risk to the participant's safety; or the participant has, at the Screening Visit:
  • a serum creatinine value more than 1.5 times the upper limit of the reference range
  • a serum total bilirubin value more than 1.5 times the upper limit of the reference range
  • a serum ALT or AST value more than 2 times the upper limit of the reference range
  • The participant has an abnormal TSH level. Participant with thyroid disease may be enrolled in the trial provided they are stable and euthyroid at the discretion of the investigator.
  • The participant has, at the Screening Visit:
  • an abnormal ECG that is, in the investigator's opinion, clinically significant
  • a QTcF interval more than 450 ms (based on the Fridericia correction where QTcF = QT/RR0.33)
  • The participant has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the trial.
  • The participant is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
  • The participant has attempted suicide within the last 12 months or is at significant risk of suicide (either in the opinion of the investigator or defined as a 'yes' to suicidal ideation questions 4 or 5 or answering 'yes' to suicidal behavior questions on the C-SSRS within the last 12 months).

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

30 sites in 1 country

Japan30 sites, 30 recruiting

  • Bandai Mental Clinic

    Chuo-ku, Niigata

    Recruiting

  • Harai Clinic

    Chuo-ku, Tokyo

    Recruiting

  • Kaku Mental Clinic

    Chūōku, Fukuoka

    Recruiting

  • Tokyo Metropolitan Children's Medical Center

    Fuchū, Tokyo

    Recruiting

  • University of the Ryukyus Hospital

    Ginowan, Okinawa

    Recruiting

  • Hirosaki University Hospital

    Hirosaki, Aomori

    Recruiting

  • Cerisier Heart Clinic

    Kagoshima

    Recruiting

  • Nara Medical University Hospital

    Kashihara, Nara

    Recruiting

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa

    Recruiting

  • National Center of Neurology and Psychiatry

    Kodaira, Tokyo

    Recruiting

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, Saitama

    Recruiting

  • Yuge Neuropsychiatric Hospital

    Kumamoto

    Recruiting

  • Aiiku Clinic

    Minato-ku, Tokyo

    Recruiting

  • Pauroom

    Minato-ku, Tokyo

    Recruiting

  • Miyakonojo Shinsei Hospital

    Miyakonojō, Miyazaki

    Recruiting

  • Chikama Clinic

    Miyazaki

    Recruiting

  • Nagoya City University Hospital

    Nagoya, Aichi-ken

    Recruiting

  • Kochi Medical School Hospital

    Nankoku, Kochi

    Recruiting

  • Osaka Metropolitan University Hospital

    Osaka

    Recruiting

  • Kindai University Hospital

    Ōsaka-sayama, Osaka

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido

    Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi

    Recruiting

  • Jisenkai Nanko Psychiatric Institute

    Shirakawa, Fukushima

    Recruiting

  • Kai Kokoro Clinic

    Suginome, Tokyo

    Recruiting

  • Shin-Otsuka Clinic

    Toshima-ku, Tokyo

    Recruiting

  • Toyama University Hospital

    Toyama

    Recruiting

  • Imurokokorono-clinic

    Urasoe, Okinawa

    Recruiting

  • Kanagawa Children's Medical Center

    Yokohama, Kanagawa

    Recruiting

  • Yokohama City University Hospital

    Yokohama, Kanagawa

    Recruiting

  • NHO Shikoku Medical Center for Children and Adults

    Zentsujichó, Kagawa-ken

    Recruiting

Other trials in Japan

About this study

Official title: 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)

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.

Being tested
Vortioxetine tablets, Placebo tablets
Keywords
Drug Therapy
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vortioxetine tabletsDrug

    Also called Trintellix

    Vortioxetine tablets

  • Placebo tabletsDrug

    Placebo tablets

Study groups in NCT07204314
Study groupRoleWhat they receive
VortioxetineExperimentalParticipants will receive the study drug, orally, once, daily (QD) for 14 weeks. The vortioxetine dose will be started at 10 mg per day, and can be increased to 20 mg per day.
Receives: Drug: Vortioxetine tablets
PlaceboPlacebo comparatorParticipants will receive the study drug, orally, once, daily (QD) for 14 weeks.
Receives: Drug: Placebo tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the Children Depression Rating Scale Revised version (CDRS-R) Total Score

    The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parents/legal guardians and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. The total score ranges from 17 (normal) to 113 (severe depression). Higher scores indicate greater severity of depression.

    Measured: Baseline, Week 14

Secondary outcomes (11)

  1. Change from Baseline in the CDRS-R Total Score at Each Time Point

    The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parents/legal guardians and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. The total score ranges from 17 (normal) to 113 (severe depression). Higher scores indicate greater severity of depression.

    Measured: Baseline, Week 2, 4, 6, 8, and 10

  2. CDRS-R Response at Each Time Point

    CDRS-R response is defined as at least 50 percent reduction in the CDRS-R total score from Baseline, calculated as the change from baseline divided by the result of subtracting 17 from the Baseline score. CDRS-R response at each time point will be reported.

    Measured: Week 2, 4, 6, 8, 10, and 14

  3. Remission at Each Time Point

    Remission is defined as less than or equal to 28 in the CDRS-R total score. Remission at each time point will be reported.

    Measured: Week 2, 4, 6, 8, 10, and 14

  4. Change from Baseline in the Patient Health Questionnaire-9 for Adolescents (PHQ-A) at Each Time Point

    The PHQ-A is a participant-rated scale designed to screen for depressive symptoms in adolescents. The 9 depression items are rated on a 4-point scale (0=Not at all; 1=Several days; 2=More than half the days; and 3=Nearly every day). The total score can range from 0 to 27, with higher scores indicating greater severity of depression.

    Measured: Baseline, Week 4, 6 and 14

  5. Change from Baseline in the Digit Symbol Substitution Test (DSST) at Each Time Point

    The DSST is a paper-and-pencil cognitive test. After viewing a predetermined table of pairs of numbers and symbols, participants replace each symbol with its corresponding number, one by one. The number of correct symbols within the allowed time, usually 90 seconds, constitutes the score. The DSST score ranges from 0 to 133, with lower scores indicating lower cognitive function.

    Measured: Baseline, Week 4 and 14

  6. Change from Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Each Time Point

    The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill participants).

    Measured: Baseline, Week 2, 4, 6, 8, 10, and 14

  7. Score in the Clinical Global Impression - Global Improvement (CGI-I) at Each Time Point

    The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).

    Measured: Week 4, 6, 8, 10, and 14

  8. Remission in the CGI-S Score at Each Time Point

    Remission in the CGI-S score is defined as a CGI-S score of 1 or 2. Remission in the CGI-S score at each time point will be reported.

    Measured: Week 2, 4, 6, 8, 10, and 14

  9. Response in the CGI-I Score at Each Time Point

    Response in the CGI-I Score is defined as defined as a CGI-I score of 1 or 2. Response in the CGI-I score at each time point will be reported.

    Measured: Week 4, 6, 8, 10, and 14

  10. Change from Baseline in the Sheehan Disability Scale - Adolescent Version (SDS-A) at Each Time Point

    The SDS-A assesses functional impairment in 3 major life domains: school/work, social life/leisure activities, and family life/home responsibilities. The 3 life domains are rated on a 11-point scale from 0 (Not at all) to 10 (Extremely). The total score ranges from 0 to 30, with higher scores indicating greater pathology.

    Measured: Baseline, Week 4 and 14

  11. Plasma Concentrations of Vortioxetine

    Measured: Week 6, 10, and 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2025
  2. Study start1 Oct 2025
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07204314
Sponsor's protocol ID
Vortioxetine-3023
Other IDs
U1111-1314-6051, jRCT2031250396
Status last verified
Oct 2026
First submitted
30 Sep 2025
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vortioxetine tablets in people with Major Depressive Disorder, run by Takeda at 30 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the Children Depression Rating Scale Revised version (CDRS-R) Total Score (time frame: Baseline, Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07204314.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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