Actively Recruiting
A Randomized, Double-blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once-Daily Oral Vortioxetine in Japanese Pediatric Patients 12 to 17 Years With Major Depressive Disorder
Led by Takeda · Updated on 2026-05-22
180
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well vortioxetine, taken at doses of 10 mg or 20 mg daily, works compared to a placebo in treating depression symptoms in Japanese teenagers aged 12 to 17 years diagnosed with Major Depressive Disorder (MDD). This study is designed as a randomized, double-blind, placebo-controlled Phase 3 trial to assess both the effectiveness and side effects of the medication. Participants will take the study drug orally once a day for 14 weeks. The dose starts at 10 mg per day and may be increased to 20 mg per day. The study includes a screening period of up to 15 days to confirm eligibility, followed by the 14-week treatment period, and then a 4-week follow-up to monitor for any side effects after stopping the medication. During the approximately 20-week participation, individuals will visit the clinic 13 times for assessments. These include evaluating depression severity using the Children's Depression Rating Scale Revised (CDRS-R) at baseline and week 14, along with other scales such as the Patient Health Questionnaire-9 for Adolescents and Clinical Global Impression scores at multiple time points. Researchers will also monitor vortioxetine blood levels, safety, tolerability, and any side effects throughout the study.
CONDITIONS
Brief Title
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Japanese males or females aged 12 to 17 years at consent (those turning 18 during the trial may continue)
- Ability to communicate with study staff
- Ability to understand assent form and parent/guardian ability to understand consent form
- Written informed assent from participant and consent from parent/legal guardian
- Willingness and ability to attend all trial visits within specified time windows
- Outpatient status consulting a clinician
- Primary diagnosis of Major Depressive Disorder or persistent depressive disorder with major depressive episodes per DSM-5-TR confirmed by MINI-KID
- CDRS-R total score ≥ 45 at screening and baseline
- CGI-S score ≥ 4 at screening and baseline
- PHQ-A score ≥ 10 at baseline
- For females capable of viable ova production, agreement to use effective contraception and avoid ova donation from consent until 30 days after last dose
- Negative urine pregnancy test at screening for females
You will not qualify if you...
- Previous participation and progression to Phase A in this trial
- Participation in any clinical trial within 30 days before screening
- Being trial personnel, their immediate family, or subordinates
- Prior treatment with vortioxetine
- History of major depressive episode resistant to two or more adequate antidepressant treatments
- Under forced treatment
- Recent environmental changes impacting disease or trial plans
- Pregnant or breastfeeding
- Ongoing psychotherapy started less than 3 months prior or planned intensification during trial (except supportive psychotherapy)
- History of severe drug allergy or hypersensitivity to IMPs or excipients
- Hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltose insufficiency
- Primary diagnosis of other psychiatric disorders like PTSD, OCD, ASD, ADHD
- History of substance or alcohol use disorder within 6 months before screening
- Current use or positive test for drugs of abuse
- Medical, organic, or drug-induced mental disorders
- Intellectual disability or clinical/social history indicating intellectual disability
- Disorders requiring prioritized treatment over MDD or interfering with trial
- History of moderate or severe head trauma or neurological/systemic diseases affecting CNS
- First-degree relative with bipolar disorder
- Inability to swallow tablets
- History of cancer not in remission for over 5 years
- Clinically relevant neurological, psychiatric, cardiovascular, respiratory, hepatic, renal, metabolic, endocrinological, gastrointestinal, hematological, infectious, immunological, dermatological, venereal, or ophthalmological conditions
- Use or anticipated use of disallowed medications or procedures during trial
- Clinically significant abnormal vital signs at screening
- Abnormal lab values posing safety risks at screening
- Abnormal thyroid-stimulating hormone level unless stable and euthyroid
- Abnormal ECG or prolonged QTcF interval
- Diseases or medications interfering with safety, tolerability, efficacy, or trial conduct
- Unlikely to comply with protocol or unsuitable for trial
- Suicide attempt within 12 months or significant suicide risk per assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 weeks
Participants receive once-daily oral vortioxetine or placebo tablets for their major depressive disorder.
Multiple visits at Baseline, Weeks 2, 4, 6, 8, 10, and 14
Trial Site Locations
Total: 30 locations
1
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Actively Recruiting
2
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Actively Recruiting
3
Kaku Mental Clinic
Chūōku, Fukuoka, Japan
Actively Recruiting
4
Jisenkai Nanko Psychiatric Institute
Shirakawa, Fukushima, Japan
Actively Recruiting
5
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Actively Recruiting
6
NHO Shikoku Medical Center for Children and Adults
Zentsujichó, Kagawa-ken, Japan
Actively Recruiting
7
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
Not Yet Recruiting
8
Kanagawa Children's Medical Center
Yokohama, Kanagawa, Japan
Actively Recruiting
9
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Actively Recruiting
10
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Actively Recruiting
11
Tohoku University Hospital
Sendai, Miyagi, Japan
Not Yet Recruiting
12
Miyakonojo Shinsei Hospital
Miyakonojō, Miyazaki, Japan
Actively Recruiting
13
Nara Medical University Hospital
Kashihara, Nara, Japan
Actively Recruiting
14
Bandai Mental Clinic
Chuo-ku, Niigata, Japan
Actively Recruiting
15
University of the Ryukyus Hospital
Ginowan, Okinawa, Japan
Actively Recruiting
16
Imurokokorono-clinic
Urasoe, Okinawa, Japan
Actively Recruiting
17
Kindai University Hospital
Ōsaka-sayama, Osaka, Japan
Actively Recruiting
18
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, Japan
Actively Recruiting
19
Harai Clinic
Chuo-ku, Tokyo, Japan
Actively Recruiting
20
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, Japan
Actively Recruiting
21
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan
Not Yet Recruiting
22
Aiiku Clinic
Minato-ku, Tokyo, Japan
Actively Recruiting
23
Pauroom
Minato-ku, Tokyo, Japan
Actively Recruiting
24
Kai Kokoro Clinic
Suginome, Tokyo, Japan
Actively Recruiting
25
Shin-Otsuka Clinic
Toshima-ku, Tokyo, Japan
Actively Recruiting
26
Cerisier Heart Clinic
Kagoshima, Japan
Actively Recruiting
27
Yuge Neuropsychiatric Hospital
Kumamoto, Japan
Actively Recruiting
28
Chikama Clinic
Miyazaki, Japan
Actively Recruiting
29
Osaka Metropolitan University Hospital
Osaka, Japan
Actively Recruiting
30
Toyama University Hospital
Toyama, Japan
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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