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| ID | Type | Description | Link |
|---|---|---|---|
| 54135419TRD4017 | Other Identifier | Janssen Research & Development, LLC |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esketamine Nasal Spray | Experimental | Participants will self-administer one esketamine (flexibly dosed; 56 or 84 milligrams [mg]) nasal spray into each nostril (that is, a total of 2 sprays using 1 intranasal device) twice a week for 4 weeks. For 84 mg, sprays to each nostril will be delivered in rapid succession at 3 different time points (3 devices total). 56 mg will have 2 devices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine 56 mg | Drug | Participants will self-administer 56 mg of esketamine as intranasal spray into each nostril. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cha Ilsan Medical Center | Recruiting | Goyang Si Gyeonggi Do | 10414 | South Korea | ||
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Esketamine 84 mg | Drug | Participants will self-administer 84 mg of esketamine as intranasal spray into each nostril. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | Baseline up to Week 4 |
| Wonkwang University Hospital |
| Recruiting |
| Iksan |
| 570 711 |
| South Korea |
| Kangbuk Samsung Hospital | Recruiting | Seoul | 03181 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Kyung Hee University Hospital | Recruiting | Seoul | 130 050 | South Korea |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
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