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CompletedPhase 4

A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression

NCT07053345 · Janssen Korea, Ltd., Korea

Closed to entry
Status
Not accepting participants
Phase 4
Phase
47
Target enrolment
6
Study sites
Outside the US

What it is testing

Summary

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change From Baseline to Day 28 in Hamilton Depression Rating Scale (HAM-D) Total Score

    Measured over Baseline up to Day 28

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

6 study sites

FacilityCityRegionCountry
Cha Ilsan Medical CenterGoyang Si Gyeonggi DoSouth Korea
Wonkwang University HospitalIksanSouth Korea
Kangbuk Samsung HospitalSeoulSouth Korea
Asan Medical CenterSeoulSouth Korea
Samsung Medical CenterSeoulSouth Korea
Kyung Hee University HospitalSeoulSouth Korea

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT07053345 on ClinicalTrials.gov →

Last updated in the registry 2026-08-03. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits