A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
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)
Janssen Korea, Ltd., Korea
47 participants
Jun 9, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria5
- 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
Interventions
Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril.
Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT07053345