Actively Recruiting
An Interventional Open-label Multicenter Study to Evaluate the Efficacy and Safety of Esketamine Nasal Spray in Korean Adults With Treatment-Resistant Depression
Led by Janssen Korea, Ltd., Korea · Updated on 2026-06-05
47
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well esketamine nasal spray works to improve depressive symptoms in adults with treatment-resistant depression. The study focuses on participants aged 18 to 64 who have not responded to at least two oral antidepressant treatments during their current depressive episode. The main goal is to measure changes in depression severity using the Hamilton Depression Rating Scale (HAM-D) over a 4-week treatment period. Participants will self-administer esketamine nasal spray twice a week for four weeks. The dose will be flexible, either 56 mg or 84 mg, delivered as one spray into each nostril per session. For the 84 mg dose, sprays will be given in rapid succession at three different time points using three devices, while the 56 mg dose requires two devices. This open-label, single-arm study will monitor participants throughout the treatment phase. During the study, participants will be assessed regularly using the HAM-D scale and other measures such as the Patient Health Questionnaire (PHQ-9) and Clinical Global Impression-Severity (CGI-S) scale to track changes in depressive symptoms. The primary outcome is the change in HAM-D total score from baseline to Day 28. Safety and treatment response will also be monitored. The total participation time covers the 4-week treatment phase, with evaluations at baseline and throughout the study period.
CONDITIONS
Brief Title
A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have a confirmed diagnosis of major depressive disorder without psychotic features
- Hamilton depression rating scale (HAM-D; 17-item) total score of 22 or higher at screening and Day 1
- Non-response (25% or less improvement) to at least 2 oral antidepressant treatments during current moderate to severe depression episode of at least 6 weeks duration
- Confirmed minimal clinical improvement and nonresponse to current antidepressant treatment at baseline (Day 1)
- Female participants of childbearing potential must have a negative pregnancy test at screening and before first dose
You will not qualify if you...
- Untreated or insufficiently treated hyperthyroidism
- History of malignancy within 5 years before screening
- Known allergies or intolerance to esketamine, ketamine, or their ingredients
- Use of an investigational intervention or invasive investigational medical device within 60 days before first dose or data collection
- Current participation in another investigational study for major depressive disorder or treatments affecting mood
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.
Duration - 4 weeks
Participants self-administer esketamine nasal spray twice a week for 4 weeks.
Twice weekly visits for 4 weeks
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
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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