Esketamine nasal spray for treatment-resistant depression in Korean adults
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)
This will test whether esketamine nasal spray can reduce depressive symptoms in Korean adults whose depression has not improved after at least two antidepressants.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Janssen Korea, Ltd., Korea Industry-sponsored |
| Locations | 6 sites (Goyang Si Gyeonggi Do and 5 other locations) |
| Trial ID | NCT07053345 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional study gives esketamine nasal spray at two fixed doses (56 mg and 84 mg) over a 4-week treatment phase at clinical sites in Korea. Participants must have major depressive disorder without psychotic features and meet criteria for treatment-resistant depression after inadequate response to at least two oral antidepressants. The main measure is the change in the 17-item Hamilton Depression Rating Scale total score from baseline (Day 1) to the end of treatment (Day 28). Diagnosis is confirmed with the MINI and symptom thresholds (HAM-D ≥22) are required at screening and baseline.
Who should consider this trial
Good fit: Adults in Korea with major depressive disorder without psychotic features who have not adequately improved after at least two adequate antidepressant trials and have a HAM-D (17-item) score of 22 or higher are the intended candidates.
Not a fit: Patients with psychotic features, those who respond to standard antidepressants, or those who do not meet the HAM-D severity threshold or eligibility requirements are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the treatment could produce faster and clinically meaningful reductions in depressive symptoms for people with treatment-resistant depression.
How similar studies have performed: Previous clinical trials and regulatory approvals of esketamine for treatment-resistant depression have shown rapid antidepressant effects, so this is testing those effects specifically in a Korean population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Participants with hyperthyroidism that has not been sufficiently treated * History of malignancy within 5 years of enrollment before screening * Known allergies, hypersensitivity, or intolerance to esketamine/ketamine or its excipients * 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 * Currently enrolled in an investigational study that involves treatments for MDD or may otherwise be expected to impact mood
Where this trial is running
Goyang Si Gyeonggi Do and 5 other locations
- Cha Ilsan Medical Center — Goyang Si Gyeonggi Do, South Korea (Recruiting)
- Wonkwang University Hospital — Iksan, South Korea (Recruiting)
- Kangbuk Samsung Hospital — Seoul, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Kyung Hee University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.