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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
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.
Cha Ilsan Medical Center
Goyang Si Gyeonggi Do, South Korea
RECRUITINGWonkwang University Hospital
Iksan, South Korea
RECRUITINGKangbuk Samsung Hospital
Seoul, South Korea
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 28
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 4
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 4
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.
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Asan Medical Center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGKyung Hee University Hospital
Seoul, South Korea
RECRUITINGTime frame: Up to Week 4
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 4
Percentage of Participants With Remission Based on HAM-D Total Score Over Time
Percentage of participants with remission 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 4
Percentage of Participants With Remission Based on PHQ-9 Total Score Over Time
Percentage of participants with remission 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 4
Percentage of Participants With Clinically Meaningful Improvement Based on HAM-D Total Score Over Time
Percentage of participants with clinically meaningful improvement 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 4
Percentage of Participants With Clinically Meaningful Improvement Based on PHQ-9 Total Score Over Time
Percentage of participants with clinically meaningful improvement based on total score 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 4
Change From Baseline Over Time for Clinical Global Impression-Severity (CGI-S) Score
The CGI-S is a clinician-rated scales that measure illness severity. The CGI has proved to be a robust measure of efficacy in many clinical drug trials and is easy and quick to administer. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill participants).
Time frame: Baseline up to Week 4