Actively Recruiting
A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
Led by Janssen Korea, Ltd., Korea · Updated on 2026-05-08
47
Participants Needed
6
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate how well esketamine nasal spray works in improving depressive symptoms in participants with treatment resistant depression (TRD). This will be assessed by the change from baseline in the Hamilton depression rating scale (HAM-D; 17-item) total score from Day 1 (baseline) to the end of the 4-week treatment phase (Day 28).
CONDITIONS
Official Title
A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of major depressive disorder (MDD) without psychotic features based on clinical assessment and MINI
- Hamilton Depression Rating Scale (HAM-D; 17-item) total score of 22 or higher at screening and Day 1
- Non-response (less than or equal to 25% improvement) to at least 2 oral antidepressant treatments during the current moderate to severe depressive episode after adequate dose and duration of at least 6 weeks
- At baseline (Day 1), evaluation confirms continued nonresponse and minimal clinical improvement with current antidepressant treatment
- Female participants of childbearing potential must have a negative serum pregnancy test at screening and urine test before first study dose
You will not qualify if you...
- Untreated hyperthyroidism
- History of cancer within 5 years before screening
- Known allergies, hypersensitivity, or intolerance to esketamine, ketamine, or their ingredients
- Received investigational drug or invasive investigational medical device within 60 days before first study dose or data collection
- Currently enrolled in another investigational study involving treatments for major depressive disorder or that may affect mood
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Cha Ilsan Medical Center
Goyang Si Gyeonggi Do, South Korea, 10414
Actively Recruiting
2
Wonkwang University Hospital
Iksan, South Korea, 570 711
Actively Recruiting
3
Kangbuk Samsung Hospital
Seoul, South Korea, 03181
Actively Recruiting
4
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
5
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
6
Kyung Hee University Hospital
Seoul, South Korea, 130 050
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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