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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Esketamine 56 mg
DrugParticipants will self-administer 56 mg of esketamine as intranasal spray into each nostril.
Esketamine 84 mg
DrugParticipants will self-administer 84 mg of esketamine as intranasal spray into each nostril.
Treatment groups
47 Participants
are divided into 1 treatment groupGroup A: Esketamine Nasal SprayExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
Baseline up to Day 28Secondary outcomes
1
Change From Baseline Over Time for 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.
Time frame
Baseline up to Week 42
Change From Baseline Over Time for Patient Health Questionnaire 9-item (PHQ-9) Total Score
The PHQ-9 is a validated 9-item, patient-reported outcomes (PRO) measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) major depressive disorder (MDD) criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
Time frame
Baseline up to Week 43
Percentage of Participants With Response Based on HAM-D Total Score Over Time
Percentage of participants with response based on HAM-D total score over time will be reported. 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.
Time frame
Up to Week 44
Percentage of Participants With Response Based on PHQ-9 Total Score Over Time
Percentage of participants with response based on PHQ-9 total score over time will be reported. The PHQ-9 is a validated 9-item, PRO measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria and it has been used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
Time frame
Up to Week 4Sponsors and contacts
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Source ClinicalTrials.gov