NCT07053345CompletedPhase 4
A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
An Interventional, Open-label, Single Arm, Multicenter Study to Evaluate the Efficacy and Safety of Esketamine Nasal Spray in Korean Participants With Treatment-Resistant Depression(TRD)
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 27 Jun 2025
- Start date
- 9 Jun 2025
- Primary completion date
- 13 Jul 2026
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Diseases
- Depression
- NCT number
- NCT07053345
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 47
- From 9 Jun 2025 to the primary completion date, 13 Jul 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received an investigational intervention or used an invasive investigational medical device within 60 days before the planned first dose of study intervention or first data collection time point
Other illness
- History of malignancy within 5 years of enrollment before screening
- Known allergies, hypersensitivity, or intolerance to esketamine/ketamine or its excipients
Other
- Participants with hyperthyroidism that has not been sufficiently treated
- Currently enrolled in an investigational study that involves treatments for MDD or may otherwise be expected to impact mood
Who the study is looking for
- Must have a confirmed diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition at the time of enrollment, without psychotic features, based on clinical assessment, and confirmed by mini international neuropsychiatric interview (MINI)
- Must have a Hamilton depression rating scale (HAM-D; 17-item) total score greater than or equal to (\>=) 22 at screening and Day 1
- Participants must have had non-response (less than or equal to \[\<=\] 25 percent \[%\] improvement of symptoms) to \>= 2 oral antidepressant treatments in the current moderate to severe episode of depression after having been given at an adequate dosage for an adequate duration of at least 6 weeks
- At baseline (Day 1), the investigator will evaluate any changes in the participant's signs/symptoms of depression since the screening assessment and confirm that the inclusion criteria for the current antidepressant (AD) treatment are still met (that is, nonresponse and minimal clinical improvement)
- A female participant of childbearing potential must have a negative serum pregnancy test at screening and urine prior to the first dose of study intervention on Day 1
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cha Ilsan Medical Center Coordinator of this site? Confirm its status | Goyang Si Gyeonggi Do | South Korea | Unknown status |
| Wonkwang University Hospital Coordinator of this site? Confirm its status | Iksan | South Korea | Unknown status |
| Kyung Hee University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.