Depressive Disorder, Treatment-ResistantPhase 4NCT07053345
A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
A Phase 4 study testing Esketamine 56 mg and Esketamine 84 mg in people with Depressive Disorder, Treatment-Resistant, run by Janssen Korea, Ltd., Korea at 6 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant
- What is being tested?
- Esketamine 56 mg and Esketamine 84 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 9 Jun 2025to 13 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Cha Ilsan Medical Center
Goyang Si Gyeonggi Do, 10414
Wonkwang University Hospital
Iksan, 570 711
Kangbuk Samsung Hospital
Seoul, 03181
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Kyung Hee University Hospital
Seoul, 130 050
About this study
Official title: 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)
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
- Depressive Disorder, Treatment-Resistant
- Being tested
- Esketamine 56 mg, Esketamine 84 mg
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine 56 mgDrug
Also called JNJ-54135419
Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.
Esketamine 84 mgDrug
Also called JNJ-54135419
Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.
| Study group | Role | What they receive |
|---|---|---|
| Esketamine Nasal Spray | Experimental | Participants will self-administer one esketamine (flexibly dosed; 56 or 84 milligrams [mg]) nasal spray into each nostril (that is, a total of 2 sprays using 1 intranasal device) twice a week for 4 weeks. For 84 mg, sprays to each nostril will be delivered in rapid succession at 3 different time points (3 devices total). 56 mg will have 2 devices. Receives: Drug: Esketamine 56 mg; Drug: Esketamine 84 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Day 28 in Hamilton Depression Rating Scale (HAM-D) Total Score
The HAM-D contains 17 items pertaining to symptoms of depression experienced over the past week. The questions cover core symptoms of depression as well as appetite and sleep (3 items). Items are scored on a likert scale of 0-4 or 0-2 depending on the item with a possible range of 0-52, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline up to Day 28
Secondary outcomes (9)
Change From Baseline Over Time for HAM-D Total Score
The HAM-D contains 17 items pertaining to symptoms of depression experienced over the past week. The questions cover core symptoms of depression as well as appetite and sleep (3 items). Items are scored on a likert scale of 0-4 or 0-2 depending on the item with a possible range of 0-52, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline up to Week 4
Change From Baseline Over Time for Patient Health Questionnaire 9-item (PHQ-9) Total Score
The PHQ-9 is a validated 9-item, patient-reported outcomes (PRO) measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) major depressive disorder (MDD) criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline up to Week 4
Percentage of Participants With Response Based on HAM-D Total Score Over Time
Percentage of participants with response based on HAM-D total score over time will be reported. The HAM-D contains 17 items pertaining to symptoms of depression experienced over the past week. The questions cover core symptoms of depression as well as appetite and sleep (3 items). Items are scored on a likert scale of 0-4 or 0-2 depending on the item with a possible range of 0-52, with higher scores indicating greater severity of depressive symptoms.
Measured: Up to Week 4
Percentage of Participants With Response Based on PHQ-9 Total Score Over Time
Percentage of participants with response based on PHQ-9 total score over time will be reported. The PHQ-9 is a validated 9-item, PRO measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
Measured: Up to Week 4
Percentage of Participants With Remission Based on HAM-D Total Score Over Time
Percentage of participants with remission based on HAM-D total score over time will be reported. The HAM-D contains 17 items pertaining to symptoms of depression experienced over the past week. The questions cover core symptoms of depression as well as appetite and sleep (3 items). Items are scored on a likert scale of 0-4 or 0-2 depending on the item with a possible range of 0-52, with higher scores indicating greater severity of depressive symptoms.
Measured: Up to Week 4
Percentage of Participants With Remission Based on PHQ-9 Total Score Over Time
Percentage of participants with remission based on PHQ-9 total score over time will be reported. The PHQ-9 is a validated 9-item, PRO measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
Measured: Up to Week 4
Percentage of Participants With Clinically Meaningful Improvement Based on HAM-D Total Score Over Time
Percentage of participants with clinically meaningful improvement based on HAM-D total score over time will be reported. The HAM-D contains 17 items pertaining to symptoms of depression experienced over the past week. The questions cover core symptoms of depression as well as appetite and sleep (3 items). Items are scored on a likert scale of 0-4 or 0-2 depending on the item with a possible range of 0-52, with higher scores indicating greater severity of depressive symptoms.
Measured: Up to Week 4
Percentage of Participants With Clinically Meaningful Improvement Based on PHQ-9 Total Score Over Time
Percentage of participants with clinically meaningful improvement based on total score PHQ-9 total score over time will be reported. The PHQ-9 is a validated 9-item, PRO measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
Measured: Up to Week 4
Change From Baseline Over Time for Clinical Global Impression-Severity (CGI-S) Score
The CGI-S is a clinician-rated scales that measure illness severity. The CGI has proved to be a robust measure of efficacy in many clinical drug trials and is easy and quick to administer. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill participants).
Measured: Baseline up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start9 Jun 2025
- Primary completion13 Jul 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, Treatment-ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053345
- Sponsor's protocol ID
- 54135419TRD4017
- Other IDs
- 54135419TRD4017
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07053345
- Acronym / sponsor ID
- 54135419TRD4017
- Conditions
- Depressive Disorder, Treatment-Resistant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esketamine Nasal Spray | Experimental | Drug: Esketamine 56 mg, Drug: Esketamine 84 mgParticipants will self-administer one esketamine (flexibly dosed; 56 or 84 milligrams [mg]) nasal spray into each nostril (that is, a total of 2 sprays using 1 intranasal device) twice a week for 4 weeks. For 84 mg, sprays to each nostril will be delivered in rapid succession at 3 different time points (3 devices total). 56 mg will have 2 devices. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esketamine 56 mgAlso: JNJ-54135419Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril. | Drug | Esketamine Nasal Spray |
| Esketamine 84 mgAlso: JNJ-54135419Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril. | Drug | Esketamine Nasal Spray |
Primary outcome
Change From Baseline to Day 28 in Hamilton Depression Rating Scale (HAM-D) Total Score
Time frame: Baseline up to Day 28
The HAM-D contains 17 items pertaining to symptoms of depression experienced over the past week. The questions cover core symptoms of depression as well as appetite and sleep (3 items). Items are scored on a likert scale of 0-4 or 0-2 depending on the item with a possible range of 0-52, with higher scores indicating greater severity of depressive symptoms.
9 secondary outcomes
Change From Baseline Over Time for HAM-D Total Score
Time frame: Baseline up to Week 4
Change From Baseline Over Time for Patient Health Questionnaire 9-item (PHQ-9) Total Score
Time frame: Baseline up to Week 4
Percentage of Participants With Response Based on HAM-D Total Score Over Time
Time frame: Up to Week 4
Percentage of Participants With Response Based on PHQ-9 Total Score Over Time
Time frame: Up to Week 4
Percentage of Participants With Remission Based on HAM-D Total Score Over Time
Time frame: Up to Week 4
Percentage of Participants With Remission Based on PHQ-9 Total Score Over Time
Time frame: Up to Week 4
Percentage of Participants With Clinically Meaningful Improvement Based on HAM-D Total Score Over Time
Time frame: Up to Week 4
Percentage of Participants With Clinically Meaningful Improvement Based on PHQ-9 Total Score Over Time
Time frame: Up to Week 4
Change From Baseline Over Time for Clinical Global Impression-Severity (CGI-S) Score
Time frame: Baseline up to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine 56 mg and Esketamine 84 mg in people with Depressive Disorder, Treatment-Resistant, run by Janssen Korea, Ltd., Korea at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Day 28 in Hamilton Depression Rating Scale (HAM-D) Total Score (time frame: Baseline up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.