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

NCT07204314 | Recruiting Phase 3

• 3 other identifiers: Vortioxetine-3023U1111-1314-6051jRCT2031250396
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 30

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.

Conditions

Major Depressive Disorder

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (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.

  Baseline, Week 14

Secondary Outcomes (11)

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

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

• CDRS-R Response at Each Time Point

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

• Remission at Each Time Point

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

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

  Baseline, Week 4, 6 and 14

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

  Baseline, Week 4 and 14

Study Arms (2)

Vortioxetine

EXPERIMENTAL

Participants 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.

Drug: Vortioxetine tablets

Placebo

PLACEBO COMPARATOR

Participants will receive the study drug, orally, once, daily (QD) for 14 weeks.

Drug: Placebo tablets

Interventions

Placebo tablets DRUG

Placebo tablets

Placebo

Vortioxetine tablets DRUG

Vortioxetine tablets

Also known as: Trintellix

Vortioxetine

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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 (DSM-5-TR criteria), including posttraumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), autism spectrum disorder (ASD), and attention-deficit/hyperactivity disorder (ADHD) established as the primary diagnosis, as assessed using the MINI-KID.
• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (30)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

RECRUITING

Hirosaki University Hospital

Hirosaki, Aomori, Japan

NOT YET RECRUITING

Kaku Mental Clinic

Chūōku, Fukuoka, Japan

RECRUITING

Jisenkai Nanko Psychiatric Institute

Shirakawa, Fukushima, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

NOT YET RECRUITING

NHO Shikoku Medical Center for Children and Adults

Zentsujichó, Kagawa-ken, Japan

RECRUITING

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

NOT YET RECRUITING

Kanagawa Children's Medical Center

Yokohama, Kanagawa, Japan

RECRUITING

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

RECRUITING

Kochi Medical School Hospital

Nankoku, Kochi, Japan

NOT YET RECRUITING

Tohoku University Hospital

Sendai, Miyagi, Japan

NOT YET RECRUITING

Miyakonojo Shinsei Hospital

Miyakonojō, Miyazaki, Japan

RECRUITING

Nara Medical University Hospital

Kashihara, Nara, Japan

RECRUITING

Bandai Mental Clinic

Chuo-ku, Niigata, Japan

RECRUITING

University of the Ryukyus Hospital

Ginowan, Okinawa, Japan

RECRUITING

Imurokokorono-clinic

Urasoe, Okinawa, Japan

RECRUITING

Kindai University Hospital

Ōsaka-sayama, Osaka, Japan

NOT YET RECRUITING

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, Japan

RECRUITING

Harai Clinic

Chuo-ku, Tokyo, Japan

RECRUITING

Tokyo Metropolitan Children's Medical Center

Fuchū, Tokyo, Japan

RECRUITING

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

NOT YET RECRUITING

Aiiku Clinic

Minato-ku, Tokyo, Japan

RECRUITING

Pauroom

Minato-ku, Tokyo, Japan

RECRUITING

Kai Kokoro Clinic

Suginome, Tokyo, Japan

RECRUITING

Shin-Otsuka Clinic

Toshima-ku, Tokyo, Japan

RECRUITING

Cerisier Heart Clinic

Kagoshima, Japan

RECRUITING

Yuge Neuropsychiatric Hospital

Kumamoto, Japan

RECRUITING

Chikama Clinic

Miyazaki, Japan

RECRUITING

Osaka Metropolitan University Hospital

Osaka, Japan

RECRUITING

Toyama University Hospital

Toyama, Japan

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (30)