A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression (NCT07053345) | Clinical Trial Compass
RecruitingPhase 4
A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
South Korea47 participantsStarted 2025-06-09
Plain-language 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).
Who can participate
Age range18 Years – 64 Years
SexALL
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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
* …
What they're measuring
1
Change From Baseline to Day 28 in Hamilton Depression Rating Scale (HAM-D) Total Score