A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-64
SponsorJanssen Korea, Ltd., Korea
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Esketamine 56 mg
- Esketamine 84 mg
Treatment groups
47 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov