Actively Recruiting
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Led by Takeda · Updated on 2026-03-11
180
Participants Needed
30
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 12 to 17 years (patients turning 18 during the trial can continue)
- Able to communicate with study staff
- Able to understand assent form; parent or guardian can understand and sign consent form
- Willing to accept video recording during assessments
- Willing and able to attend study visits on schedule
- Outpatient under clinician care
- Primary diagnosis of Major Depressive Disorder or persistent depressive disorder meeting DSM-5-TR criteria without psychotic features
- Children Depression Rating Scale Revised (CDRS-R) score of 45 or higher at screening and baseline
- Clinical Global Impression-Severity (CGI-S) score of 4 or higher at screening and baseline
- Patient Health Questionnaire for Adolescents (PHQ-A) score of 10 or higher at baseline
- If female and able to conceive, agree to use effective contraception and avoid donating ova during and 30 days after treatment
- Negative urine pregnancy test at screening if female
You will not qualify if you...
- Previously entered Phase A of this trial
- Participated in a clinical trial within 30 days before screening
- Member or immediate family of trial staff or subordinate
- Previously treated with vortioxetine
- History of major depressive episode resistant to two or more adequate antidepressants
- Under forced treatment
- Recent hospitalization or major environmental change impacting disease or plans
- Pregnant or breastfeeding
- Receiving psychotherapy started less than 3 months before baseline or planned to intensify during trial
- History of severe drug allergy or hypersensitivity to study drugs or excipients
- Hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency
- Primary diagnosis of other psychiatric disorders like PTSD, OCD, ASD, or ADHD
- Substance or alcohol use disorder within 6 months before screening
- Current use or positive test for drugs of abuse
- Mental disorders caused by medical, organic, or drug causes
- Known intellectual disability or related history
- Other disorders prioritizing treatment over MDD or interfering with trial compliance
- Moderate or severe head trauma or neurological/systemic diseases affecting CNS
- First degree relative with bipolar disorder
- Unable 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 ocular disorders
- Use of disallowed medications or treatments during the trial
- Clinically significant abnormal vital signs at screening
- Laboratory test abnormalities posing safety risks
- Abnormal thyroid stimulating hormone (TSH) levels unless stable and euthyroid
- Clinically significant abnormal ECG or QTcF interval over 450 ms
- Diseases or medications interfering with safety or efficacy assessments
- Unsuitable or unlikely to comply with protocol
- Suicide attempt or significant suicide risk within last 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Actively Recruiting
2
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Not Yet 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
Not Yet 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
Not Yet 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
Not Yet 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
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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