Back to resultsA Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression (SUSTAIN-3)
Primary Purpose
Depressive Disorder, Treatment-Resistant
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esketamine Nasal Spray
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Treatment-Resistant focused on measuring Depressive Disorder, Treatment-Resistant, Esketamine, JNJ-54135419
Eligibility Criteria
Inclusion Criteria:
- Based on the prior study the participant is entering 54135419TRD3008 from: a) From ESKETINTRD3001 (NCT02417064) or ESKETINTRD3002 (NCT02418585) study: Participant has completed the induction phase and the 2-weeks follow up phase visit; or Participants completed the induction phase and was a responder and study ESKETINTRD3003 is terminated.; b) From ESKETINTRD3003 (NCT02493868) study: (1) Participant relapsed during the maintenance phase; or (2) Participant was in the induction phase of the ESKETINTRD3003 study when the study was terminated and, after completion of the induction phase, was determined to be a responder; or (3) Participant was in the optimization or maintenance phases at the time the study was terminated; or (4) or (5) Participants was in the induction phase and after completion of induction phase was determined to not meet response criteria (1) Participant completed ESKETINTRD3004 study (optimization/maintenance phase); or (2) Participant was in the induction phase of the ESKETINTRD3004 study when the study was terminated and, after completion of the induction phase, was determined to be a responder; or (3) Participant was in the optimization/maintenance phase at the time the study was terminated; (4) Participant was in the induction phase and did not meet criteria for response may be eligible for to be rolled over into 54135419TRD3008. d) From ESKETINTRD3005 (NCT02422186) study: Participant was in the induction phase of the ESKETINTRD3005 study at the time enrollment into the ESKETINTRD3004 study was closed and, after completion of the induction phase, was determined to be a responder or did not meet the criteria for response. e) From ESKETINTRD3006 study (US Study sites only) (1) Participant completed the induction phase and was a responder.
- Participant must be medically stable on the basis of physical examination, vital signs, pulse oximetry, and 12-lead Electrocardiogram (ECG) performed predose on the day of the first intranasal treatment session. If there are any abnormalities that are not specified in the inclusion and exclusion criteria, their clinical significance must be determined by the investigator and recorded in the participant's source documents and initialed by the investigator
- Participant must be medically stable according to the investigator's judgment and knowledge of the subject's medical stability in the parent study. This determination must be documented.
- A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [b-hCG]) predose on the day of the first intranasal treatment session
- During the study (that is, from the first intranasal treatment session) and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of intranasal study medication, a man who is sexually active with a woman of childbearing potential must be practicing a highly effective method of contraception with his female partner c) must agree not to donate sperm.
Exclusion Criteria:
- The evaluation of the benefit versus risk of continued esketamine nasal spray treatment is not favorable for the participant in the opinion of the investigator
- Since the last study visit in the participant's prior study, participant has suicidal ideation with intent to act per the investigator's clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS) [corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) in the suicidal ideation module of the C-SSRS] or suicidal behavior per the investigator's clinical judgment or based on the C-SSRS (corresponding to any score higher than 0 in the suicidal behavior module of the C-SSRS)
- Participant has positive test result(s) for drugs of abuse (including barbiturates, methadone, opiates, cocaine, phencyclidine, and amphetamine/methamphetamine) predose on the day of the first intranasal treatment session
- Participant has any anatomical or medical condition that, per the investigator's clinical judgment based on assessment, may impede delivery or absorption of intranasal study drug
- Participant has taken any prohibited therapies that would not permit administration of the first intranasal treatment session
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Esketamine Nasal Spray
Arm Description
Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram [mg] or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years). Participants >= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3004 (NCT02497287), or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Change From Baseline in Systolic and Diastolic Blood Pressure
Change From Baseline (predose) in systolic and diastolic blood pressure will be assessed.
Change From Baseline in Heart Rate
Change from Baseline (predose) in heart rate will be assessed.
Change From Baseline in Blood Oxygen Saturation
Change From Baseline in Blood oxygen saturation (predose) will be assessed.
Change From Baseline in Modified Observer's Assessment of Alertness/Sedation (MOAAS) Scale Score
The MOAA/S will be used to measure treatment-emergent sedation, with correlation to levels of sedation defined by the American Society of Anesthesiologists (ASA) continuum.
The MOAA/S scores range from 0=no response to painful stimulus (corresponds to ASA continuum for general anesthesia) to 5=readily responds to name spoken in normal tone (awake; corresponds to ASA continuum for minimal sedation).
Change from Baseline in Electrocardiogram (ECG) intervals
Change From Baseline (predose) in Electrocardiogram (ECG) intervals will be assessed.
Change From Baseline in Computerized Cognitive Battery Domain Score
The Change From Baseline in computerized cognitive battery will provide assessment of multiple cognitive domains, including attention, visual learning memory, and executive function.
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score
The HVLT-R is a measure of verbal learning and memory, is a 12-item word list recall test. Scores include learning, delayed recall, and recognition. The HVLT-R is a well-validated and widely used measure of verbal episodic memory.
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Change from baseline in suicidal ideation or behavior measured using C-SSRS score will be reported. C-SSRS is a clinician rated assessment of suicidal behavior and / or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Changes From Baseline Over Time in Clinical Laboratory Tests
Time to Discharge Readiness Using the Clinical Global Assessment of Discharge Readiness (CGADR)
The CGADR will be used to measure the participant's current clinical status and is the clinician's assessment of the readiness to be discharged from the study site.
Secondary Outcome Measures
Change From Baseline in Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score
The PHQ-9 is a 9-item scale used to assess depressive symptoms. The responses for each item are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.
Change From Baseline in Clinical Global Impression-Severity (CGI-S) score
The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7.
Change From Baseline in days when participants assess disruption of (1) work/school, (2) social life, leisure activities, and (3) family life/home responsibilities as Assessed by the Sheehan Disability Scale (SDS) Total Score
The SDS, a patient-reported outcome measure, is a 5 item questionnaire which has been widely used and accepted for assessment of functional and associated disability impairment. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when underproductive.
Change From Baseline in days symptoms caused participants to miss school or work or were unable to carry out normal daily responsibilitieswhen participant lost from school or work as as Assessed by the Sheehan Disability Scale (SDS)
The SDS, a patient-reported outcome measure, is a 5 item questionnaire which has been widely used and accepted for assessment of functional and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when underproductive.
Change From Baseline in days when participant was underproductive as Assessed by the Sheehan Disability Scale (SDS)
The SDS, a patient-reported outcome measure, is a 5 item questionnaire which has been widely used and accepted for assessment of functional and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when underproductive.
Change From Baseline in Participant-Reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) ) Valuation Index Score
The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. EQ-5D scores include EQ-5D valuation index score (a weighted scoring of the 5 dimension scores with a possible range from 0 to 1) and EQ5D descriptive system scores (five scores reflecting each of the 5 EQ-5D health dimensions ranging from 0 [no limitation] to 4 [incapacity]).
Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale (VAS)
EQ-5D visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.
Change From Baseline in Participant- Reported Health Related Quality of Life Using the Quality of Life in Depression Scale (QLDS)
The QLDS is a disease specific PRO designed to assess health related quality of life in patients with Major Depressive Disorder. The instrument has a recall period of "at the moment", contains 34-items with "yes"/"no" response options and takes approximately 5-10 minutes to complete. The score range is from 0 (good quality of life) to 34 (very poor quality of life).
Full Information
NCT ID
NCT02782104
First Posted
April 29, 2016
Last Updated
February 28, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02782104
Brief Title
A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
Acronym
SUSTAIN-3
Official Title
An Open-label Long-term Extension Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2016 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).
Detailed Description
This is an open-label (the researchers and participants know the treatment the participant is receiving) long-term extension study. The study will consist of 2 open-label Phases: 4-week Induction phase (if applicable) and Open-Label Optimization/Maintenance phase (variable). Participants will enter the study Induction Phase from ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3005 (NCT02422186) and ESKETINTRD3006 (US sites only). Participants will enter the study Open-Label Optimization/Maintenance phase from ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868) (if appropriate at week 16) or ESKETINTRD3006 (US sites only). In the Open-Label Induction Phase, participants will self-administer flexibly-dosed esketamine nasal spray. During first 4 weeks in Optimization/Maintenance Phase responder participants from the induction phase of study 54135419TRD3008, will continue on the same dose of esketamine nasal spray from the induction phase and have a weekly intranasal treatment session frequency. Participants entering the optimization/maintenance phase from study ESKETINTRD3005 will also have a weekly intranasal treatment session frequency. However, as the ESKETINTRD3005 intranasal study medication is blinded at the time of entry into the current study, the dose of esketamine nasal spray will be administered as outlined in protocol. Participants entering the optimization/maintenance phase from study ESKETINTRD3003 (Direct Entry) or ESKETINTRD3004 who were ongoing in the Optimization, Maintenance, or Optimization/Maintenance phase, respectively, will have the option to have their current intranasal dosing frequency adjusted at the time of entry into 54135419TRD3008 study and should remain on the selected frequency from week 1 to week 4. A one-time dose change will be permitted at study entry. After 4 weeks, esketamine nasal spray treatment sessions will be individualized to either once weekly or once every other week at the fixed 2-week interval (based on clinical global impression - severity [CGI-S] performed at that visit), and every 4 weeks for participants dosed at the 4 week interval. Participants safety will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Treatment-Resistant
Keywords
Depressive Disorder, Treatment-Resistant, Esketamine, JNJ-54135419
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esketamine Nasal Spray
Arm Type
Experimental
Arm Description
Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram [mg] or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years). Participants >= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3004 (NCT02497287), or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.
Intervention Type
Drug
Intervention Name(s)
Esketamine Nasal Spray
Other Intervention Name(s)
JNJ-54135419
Intervention Description
Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram [mg] or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years). Participants >= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585) or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame
Up to End of Study (approximately 5 years 3 months)
Title
Change From Baseline in Systolic and Diastolic Blood Pressure
Description
Change From Baseline (predose) in systolic and diastolic blood pressure will be assessed.
Time Frame
Baseline of each dosing session (predose) up to the last post-dose measurement from the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in Heart Rate
Description
Change from Baseline (predose) in heart rate will be assessed.
Time Frame
Baseline of each dosing session (predose) up to the last post-dose measurement from the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in Blood Oxygen Saturation
Description
Change From Baseline in Blood oxygen saturation (predose) will be assessed.
Time Frame
Baseline of each dosing session (predose) up to the last post-dose measurement from the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in Modified Observer's Assessment of Alertness/Sedation (MOAAS) Scale Score
Description
The MOAA/S will be used to measure treatment-emergent sedation, with correlation to levels of sedation defined by the American Society of Anesthesiologists (ASA) continuum.
The MOAA/S scores range from 0=no response to painful stimulus (corresponds to ASA continuum for general anesthesia) to 5=readily responds to name spoken in normal tone (awake; corresponds to ASA continuum for minimal sedation).
Time Frame
1 hour post-dose from the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change from Baseline in Electrocardiogram (ECG) intervals
Description
Change From Baseline (predose) in Electrocardiogram (ECG) intervals will be assessed.
Time Frame
Baseline of each dosing session (predose) up to the last post-dose measurement from the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in Computerized Cognitive Battery Domain Score
Description
The Change From Baseline in computerized cognitive battery will provide assessment of multiple cognitive domains, including attention, visual learning memory, and executive function.
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score
Description
The HVLT-R is a measure of verbal learning and memory, is a 12-item word list recall test. Scores include learning, delayed recall, and recognition. The HVLT-R is a well-validated and widely used measure of verbal episodic memory.
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Description
Change from baseline in suicidal ideation or behavior measured using C-SSRS score will be reported. C-SSRS is a clinician rated assessment of suicidal behavior and / or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Changes From Baseline Over Time in Clinical Laboratory Tests
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Time to Discharge Readiness Using the Clinical Global Assessment of Discharge Readiness (CGADR)
Description
The CGADR will be used to measure the participant's current clinical status and is the clinician's assessment of the readiness to be discharged from the study site.
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Secondary Outcome Measure Information:
Title
Change From Baseline in Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score
Description
The PHQ-9 is a 9-item scale used to assess depressive symptoms. The responses for each item are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in Clinical Global Impression-Severity (CGI-S) score
Description
The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7.
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in days when participants assess disruption of (1) work/school, (2) social life, leisure activities, and (3) family life/home responsibilities as Assessed by the Sheehan Disability Scale (SDS) Total Score
Description
The SDS, a patient-reported outcome measure, is a 5 item questionnaire which has been widely used and accepted for assessment of functional and associated disability impairment. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when underproductive.
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in days symptoms caused participants to miss school or work or were unable to carry out normal daily responsibilitieswhen participant lost from school or work as as Assessed by the Sheehan Disability Scale (SDS)
Description
The SDS, a patient-reported outcome measure, is a 5 item questionnaire which has been widely used and accepted for assessment of functional and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when underproductive.
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in days when participant was underproductive as Assessed by the Sheehan Disability Scale (SDS)
Description
The SDS, a patient-reported outcome measure, is a 5 item questionnaire which has been widely used and accepted for assessment of functional and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when underproductive.
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in Participant-Reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) ) Valuation Index Score
Description
The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. EQ-5D scores include EQ-5D valuation index score (a weighted scoring of the 5 dimension scores with a possible range from 0 to 1) and EQ5D descriptive system scores (five scores reflecting each of the 5 EQ-5D health dimensions ranging from 0 [no limitation] to 4 [incapacity]).
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale (VAS)
Description
EQ-5D visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
Title
Change From Baseline in Participant- Reported Health Related Quality of Life Using the Quality of Life in Depression Scale (QLDS)
Description
The QLDS is a disease specific PRO designed to assess health related quality of life in patients with Major Depressive Disorder. The instrument has a recall period of "at the moment", contains 34-items with "yes"/"no" response options and takes approximately 5-10 minutes to complete. The score range is from 0 (good quality of life) to 34 (very poor quality of life).
Time Frame
From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Based on the prior study the participant is entering 54135419TRD3008 from: a) From ESKETINTRD3001 (NCT02417064) or ESKETINTRD3002 (NCT02418585) study: Participant has completed the induction phase and the 2-weeks follow up phase visit; or Participants completed the induction phase and was a responder and study ESKETINTRD3003 is terminated.; b) From ESKETINTRD3003 (NCT02493868) study: (1) Participant relapsed during the maintenance phase; or (2) Participant was in the induction phase of the ESKETINTRD3003 study when the study was terminated and, after completion of the induction phase, was determined to be a responder; or (3) Participant was in the optimization or maintenance phases at the time the study was terminated; or (4) or (5) Participants was in the induction phase and after completion of induction phase was determined to not meet response criteria (1) Participant completed ESKETINTRD3004 study (optimization/maintenance phase); or (2) Participant was in the induction phase of the ESKETINTRD3004 study when the study was terminated and, after completion of the induction phase, was determined to be a responder; or (3) Participant was in the optimization/maintenance phase at the time the study was terminated; (4) Participant was in the induction phase and did not meet criteria for response may be eligible for to be rolled over into 54135419TRD3008. d) From ESKETINTRD3005 (NCT02422186) study: Participant was in the induction phase of the ESKETINTRD3005 study at the time enrollment into the ESKETINTRD3004 study was closed and, after completion of the induction phase, was determined to be a responder or did not meet the criteria for response. e) From ESKETINTRD3006 study (US Study sites only) (1) Participant completed the induction phase and was a responder.
Participant must be medically stable on the basis of physical examination, vital signs, pulse oximetry, and 12-lead Electrocardiogram (ECG) performed predose on the day of the first intranasal treatment session. If there are any abnormalities that are not specified in the inclusion and exclusion criteria, their clinical significance must be determined by the investigator and recorded in the participant's source documents and initialed by the investigator
Participant must be medically stable according to the investigator's judgment and knowledge of the subject's medical stability in the parent study. This determination must be documented.
A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [b-hCG]) predose on the day of the first intranasal treatment session
During the study (that is, from the first intranasal treatment session) and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of intranasal study medication, a man who is sexually active with a woman of childbearing potential must be practicing a highly effective method of contraception with his female partner c) must agree not to donate sperm.
Exclusion Criteria:
The evaluation of the benefit versus risk of continued esketamine nasal spray treatment is not favorable for the participant in the opinion of the investigator
Since the last study visit in the participant's prior study, participant has suicidal ideation with intent to act per the investigator's clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS) [corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) in the suicidal ideation module of the C-SSRS] or suicidal behavior per the investigator's clinical judgment or based on the C-SSRS (corresponding to any score higher than 0 in the suicidal behavior module of the C-SSRS)
Participant has positive test result(s) for drugs of abuse (including barbiturates, methadone, opiates, cocaine, phencyclidine, and amphetamine/methamphetamine) predose on the day of the first intranasal treatment session
Participant has any anatomical or medical condition that, per the investigator's clinical judgment based on assessment, may impede delivery or absorption of intranasal study drug
Participant has taken any prohibited therapies that would not permit administration of the first intranasal treatment session
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Garden Grove
State/Province
California
Country
United States
City
Glendale
State/Province
California
Country
United States
City
Oakland
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
San Rafael
State/Province
California
Country
United States
City
Hartford
State/Province
Connecticut
Country
United States
City
New Haven
State/Province
Connecticut
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Hoffman Estates
State/Province
Illinois
Country
United States
City
Joliet
State/Province
Illinois
Country
United States
City
Maywood
State/Province
Illinois
Country
United States
City
Skokie
State/Province
Illinois
Country
United States
City
Iowa City
State/Province
Iowa
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Lake Charles
State/Province
Louisiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Gaithersburg
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
New Bedford
State/Province
Massachusetts
Country
United States
City
Watertown
State/Province
Massachusetts
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Rochester Hills
State/Province
Michigan
Country
United States
City
O'Fallon
State/Province
Missouri
Country
United States
City
Saint Charles
State/Province
Missouri
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Cedarhurst
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Staten Island
State/Province
New York
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Allentown
State/Province
Pennsylvania
Country
United States
City
Media
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Lincoln
State/Province
Rhode Island
Country
United States
City
Providence
State/Province
Rhode Island
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Wichita Falls
State/Province
Texas
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Waukesha
State/Province
Wisconsin
Country
United States
City
Banfield
Country
Argentina
City
Ciudad Autonoma de Buenos Aires
Country
Argentina
City
Ciudad Autónoma De Buenos Aires
Country
Argentina
City
Cordoba
Country
Argentina
City
La Plata
Country
Argentina
City
Mendoza
Country
Argentina
City
Rosario
Country
Argentina
City
Caulfield
Country
Australia
City
Elizabeth Vale
Country
Australia
City
Frankston
Country
Australia
City
Vienna
Country
Austria
City
Aalst
Country
Belgium
City
Brugge
Country
Belgium
City
Brussel
Country
Belgium
City
Heusden-Zolder
Country
Belgium
City
Liège
Country
Belgium
City
Yvoir
Country
Belgium
City
Belo Horizonte
Country
Brazil
City
Curitiba
Country
Brazil
City
Fortaleza
Country
Brazil
City
Passo Fundo
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Recife
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Sao Paulo
Country
Brazil
City
São Bernardo do Campo
Country
Brazil
City
São Paulo
Country
Brazil
City
Bourgas
Country
Bulgaria
City
Kardzhali
Country
Bulgaria
City
Pazardzhik
Country
Bulgaria
City
Pleven
Country
Bulgaria
City
Plovdiv
Country
Bulgaria
City
Rousse
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Varna
Country
Bulgaria
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Kingston
State/Province
Ontario
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Brno
Country
Czechia
City
Plzen
Country
Czechia
City
Prague
Country
Czechia
City
Praha 10
Country
Czechia
City
Praha 2
Country
Czechia
City
Praha 6
Country
Czechia
City
Tallinn
Country
Estonia
City
Tartu
Country
Estonia
City
Kuopio
Country
Finland
City
Clermont-Ferrand Cedex 1
Country
France
City
Douai
Country
France
City
Nantes
Country
France
City
Nîmes
Country
France
City
Paris
Country
France
City
Poitiers Cedex
Country
France
City
Toulon Cedex
Country
France
City
Berlin
Country
Germany
City
Bochum
Country
Germany
City
Mainz
Country
Germany
City
Mittweida
Country
Germany
City
Oranienburg
Country
Germany
City
Pfaffenhofen
Country
Germany
City
Budapest
Country
Hungary
City
Debrecen
Country
Hungary
City
Gyor
Country
Hungary
City
Pecs
Country
Hungary
City
Sopron
Country
Hungary
City
Szekszárd
Country
Hungary
City
Vác
Country
Hungary
City
Gwangju
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Kaunas
Country
Lithuania
City
Kuala Lumpur
Country
Malaysia
City
Guadalajara
Country
Mexico
City
Leon
Country
Mexico
City
Mexico City
Country
Mexico
City
Mexico
Country
Mexico
City
Monterrey
Country
Mexico
City
San Luis Potosi
Country
Mexico
City
Belchatow
Country
Poland
City
Bialystok
Country
Poland
City
Bydgoszcz
Country
Poland
City
Gdansk
Country
Poland
City
Leszno
Country
Poland
City
Lublin
Country
Poland
City
Warszawa
Country
Poland
City
Bratislava
Country
Slovakia
City
Liptovsky Mikulas
Country
Slovakia
City
Rimavska Sobota
Country
Slovakia
City
Roznava
Country
Slovakia
City
Svidnik
Country
Slovakia
City
Cape Town
Country
South Africa
City
Pretoria
Country
South Africa
City
Welgemoed
Country
South Africa
City
Alcorcón
Country
Spain
City
Barcelona
Country
Spain
City
Bilbao
Country
Spain
City
Madrid
Country
Spain
City
Oviedo
Country
Spain
City
Palma
Country
Spain
City
Pamplona
Country
Spain
City
Sabadell
Country
Spain
City
Salamanca
Country
Spain
City
Sant Boi de Llobregat
Country
Spain
City
Torrevieja
Country
Spain
City
Vitoria-Gasteiz
Country
Spain
City
Zamora
Country
Spain
City
Halmstad
Country
Sweden
City
Lund
Country
Sweden
City
Skövde
Country
Sweden
City
Stockholm
Country
Sweden
City
Kaohsiung
Country
Taiwan
City
New Taipei
Country
Taiwan
City
Taichung
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan
Country
Taiwan
City
Adana
Country
Turkey
City
Ankara
Country
Turkey
City
Bursa
Country
Turkey
City
Istanbul
Country
Turkey
City
Kucukcekmece/Istanbul
Country
Turkey
City
Oanakkale
Country
Turkey
City
Samsun
Country
Turkey
City
Chesterfield
Country
United Kingdom
City
Derby
Country
United Kingdom
City
London
Country
United Kingdom
City
Northampton
Country
United Kingdom
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
32818917
Citation
Starr HL, Abell J, Larish A, Lewis S, DeMuro C, Gogate J, Jamieson C, Daly E, Zaki N, Kramer M. Self-reported review of the value of esketamine in patients with treatment-resistant depression: Understanding the patient experience in the STRIVE Study. Psychiatry Res. 2020 Nov;293:113376. doi: 10.1016/j.psychres.2020.113376. Epub 2020 Aug 8.
Results Reference
derived
Learn more about this trial
A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
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