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

NCT07053345 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 54135419TRD4017
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Depressive Disorder, Treatment-Resistant

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline up to Day 28

Secondary Outcomes (9)

• Change From Baseline Over Time for HAM-D Total Score

  Baseline up to Week 4

• Change From Baseline Over Time for Patient Health Questionnaire 9-item (PHQ-9) Total Score

  Baseline up to Week 4

• Percentage of Participants With Response Based on HAM-D Total Score Over Time

  Up to Week 4

• Percentage of Participants With Response Based on PHQ-9 Total Score Over Time

  Up to Week 4

• Percentage of Participants With Remission Based on HAM-D Total Score Over Time

  Up to Week 4

Study Arms (1)

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.

Drug: Esketamine 56 mg; Drug: Esketamine 84 mg

Interventions

Esketamine 56 mg DRUG

Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.

Also known as: JNJ-54135419

Esketamine Nasal Spray

Esketamine 84 mg DRUG

Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.

Also known as: JNJ-54135419

Esketamine Nasal Spray

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (6)

Cha Ilsan Medical Center

Goyang Si Gyeonggi Do, 10414, South Korea

RECRUITING

Wonkwang University Hospital

Iksan, 570 711, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Kyung Hee University Hospital

Seoul, 130 050, South Korea

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): June 25, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (6)