A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
NCT ID: NCT07053345
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
47 participants
INTERVENTIONAL
2025-06-09
2027-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Esketamine Nasal Spray
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.
Esketamine 56 mg
Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.
Esketamine 84 mg
Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.
Interventions
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Esketamine 56 mg
Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.
Esketamine 84 mg
Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
64 Years
ALL
No
Sponsors
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Janssen Korea, Ltd., Korea
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Korea, Ltd., Korea Clinical Trial
Role: STUDY_DIRECTOR
Janssen Korea, Ltd., Korea
Locations
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Cha Ilsan Medical Center
Goyang Si Gyeonggi Do, , South Korea
Wonkwang University Hospital
Iksan, , South Korea
Kyung Hee University Medical Center
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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54135419TRD4017
Identifier Type: OTHER
Identifier Source: secondary_id
54135419TRD4017
Identifier Type: -
Identifier Source: org_study_id