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54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide (Aspire I)

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ClinicalTrials.gov Identifier: NCT03039192
Recruitment Status : Completed
First Posted : February 1, 2017
Results First Posted : October 29, 2020
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Drug: Esketamine
Other: Placebo
Other: Standard of Care
Enrollment 226
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1. Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Period Title: Overall Study
Started 112 114
Treated 112 113
Completed 80 84
Not Completed 32 30
Reason Not Completed
Lost to Follow-up             4             4
Adverse event, serious fatal             0             1
Adverse event, non-fatal             0             2
Withdrawal by Subject             6             9
Discontinued from treatment phase             19             12
Other             3             2
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment Total
Hide Arm/Group Description Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1. Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 112 113 225
Hide Baseline Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of study agent in the double-blind treatment phase.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 113 participants 225 participants
37.9  (12.54) 40.8  (13.11) 39.3  (12.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 113 participants 225 participants
Female
73
  65.2%
66
  58.4%
139
  61.8%
Male
39
  34.8%
47
  41.6%
86
  38.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 113 participants 225 participants
Asian
28
  25.0%
28
  24.8%
56
  24.9%
Black or African American
7
   6.3%
5
   4.4%
12
   5.3%
More than one race
1
   0.9%
1
   0.9%
2
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.9%
1
   0.4%
Other
2
   1.8%
1
   0.9%
3
   1.3%
White
74
  66.1%
77
  68.1%
151
  67.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 113 participants 225 participants
BULGARIA
10
   8.9%
9
   8.0%
19
   8.4%
ESTONIA
1
   0.9%
3
   2.7%
4
   1.8%
GERMANY
10
   8.9%
8
   7.1%
18
   8.0%
HUNGARY
8
   7.1%
7
   6.2%
15
   6.7%
MALAYSIA
9
   8.0%
7
   6.2%
16
   7.1%
SOUTH AFRICA
8
   7.1%
7
   6.2%
15
   6.7%
SOUTH KOREA
10
   8.9%
10
   8.8%
20
   8.9%
SPAIN
20
  17.9%
24
  21.2%
44
  19.6%
TAIWAN
8
   7.1%
9
   8.0%
17
   7.6%
UNITED STATES
28
  25.0%
29
  25.7%
57
  25.3%
1.Primary Outcome
Title Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours After the First Dose (Day 2) (Last Observation Carried Forward [LOCF] Data) During Double-blind Phase
Hide Description MADRS is clinician-rated scale designed to be used in participants with Major Depressive Disorder (MDD) to measure depression severity and detect changes due to antidepressant treatment. It evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic and suicidal thoughts. Scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), summed for total possible score of 0 to 60. Higher scores represent more severe condition. Negative change in score indicates improvement.
Time Frame Baseline (Day 1, predose) and 24 hours first post dose (Day 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase and have had both a baseline and a postbaseline evaluation for MADRS total score or CGI-SS-R. Here, N (number of participants analyzed) signifies number of participants analyzed for this outcome measure.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
-12.8  (10.73) -16.4  (11.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus SOC Antidepressant Treatment, Esketamine 84 mg Plus SOC Antidepressant Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of Least Square Means
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-6.56 to -1.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.39
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Clinical Global Impression of Severity of Suicidality- Revised (CGI-SS-R) Score at 24 Hours After the First Dose (Day 2) (LOCF Data) During Double-blind Phase
Hide Description CGI-SS-R was derived from the Clinical Global Impression Severity Scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participants illness. The CGI-SS-R rating is scored on a 7-point scale from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal participants). A higher score indicates a more severe condition and a reduction in score indicates improvement (that is, lower severity of suicidality).
Time Frame Baseline (Day 1, predose) and 24 hours first post dose (Day 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase and have had both a baseline and a postbaseline evaluation for MADRS total score or CGI-SS-R. Here, N (number of participants analyzed) signifies number of participants analyzed for this outcome measure.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 111
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-5 to 1)
-1.0
(-6 to 2)
3.Secondary Outcome
Title Number of Participants Who Achieved Remission (MADRS Total Score Less Than or Equal to [<=] 12) Through the Double-blind Phase
Hide Description Participants who had a MADRS total score of <=12 were considered remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition and a negative change in score indicates improvement.
Time Frame Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25 (predose and 4 hours postdose)
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during the double-blind phase and have had both a baseline and a post-baseline evaluation for the MADRS total score or CGI-SS-R.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 (4 Hours postdose)
9
   8.0%
12
  10.7%
Day 2
10
   8.9%
21
  18.8%
Day 4
13
  11.6%
28
  25.0%
Day 8
23
  20.5%
30
  26.8%
Day 11
26
  23.2%
33
  29.5%
Day 15
29
  25.9%
38
  33.9%
Day 18
30
  26.8%
42
  37.5%
Day 22
25
  22.3%
41
  36.6%
Day 25 (Predose)
38
  33.9%
46
  41.1%
Day 25 (4 hours postdose)
42
  37.5%
60
  53.6%
4.Secondary Outcome
Title Change From Baseline in Montgomery Asberg Depression Rating Scale Total Score at Days 1, 2, 4, 8, 11, 15, 18, 22 and 25 During Double-blind Phase
Hide Description MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition and a negative change in score indicates improvement.
Time Frame Baseline and Days 1, 2, 4, 8, 11, 15, 18, 22 and 25 (predose and 4 hours postdose)
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase and have had both a baseline and a post-baseline evaluation for MADRS total score or CGI-SS-R. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified time points.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Day 1 Number Analyzed 112 participants 110 participants
-10.9  (9.69) -13.5  (10.89)
Change at Day 2 Number Analyzed 111 participants 111 participants
-12.9  (10.72) -16.4  (11.95)
Change at Day 4 Number Analyzed 110 participants 109 participants
-14.5  (11.39) -19.1  (12.29)
Change at Day 8 Number Analyzed 108 participants 104 participants
-17.4  (12.59) -19.7  (12.91)
Change at Day 11 Number Analyzed 103 participants 100 participants
-19.0  (12.08) -21.8  (12.20)
Change at Day 15 Number Analyzed 99 participants 104 participants
-20.4  (12.19) -22.3  (11.70)
Change at Day 18 Number Analyzed 94 participants 102 participants
-21.4  (12.00) -23.9  (11.77)
Change at Day 22 Number Analyzed 92 participants 103 participants
-21.6  (12.32) -24.0  (12.38)
Change at Day 25: predose Number Analyzed 92 participants 96 participants
-23.0  (12.41) -24.8  (13.63)
Change at Day 25 (4 hours postdose) Number Analyzed 88 participants 94 participants
-25.8  (10.94) -29.5  (10.89)
5.Secondary Outcome
Title Change From Baseline in Clinical Global Impression- Severity of Suicidality-Revised (CGI-SS-R) at Days 1, 2, 4, 8, 11, 15, 18, 22 and 25 During Double-blind Phase
Hide Description CGI-SS-R was derived from the Clinical Global Impression Severity Scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participants illness. The CGI-SS-R rating is scored on a 7-point scale from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal participants). A higher score indicates a more severe condition. Negative change in score indicates improvement.
Time Frame Baseline and Days 1, 2, 4, 8, 11, 15, 18, 22 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase and have had both a baseline and a post-baseline evaluation for MADRS total score or CGI-SS-R. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified time points.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Median (Full Range)
Unit of Measure: units on a scale
Change at Day 1 Number Analyzed 112 participants 110 participants
0.0
(-5 to 1)
-1.0
(-6 to 1)
Change at Day 2 Number Analyzed 112 participants 112 participants
-1.0
(-5 to 1)
-1.0
(-6 to 2)
Change at Day 4 Number Analyzed 110 participants 110 participants
-1.0
(-5 to 1)
-2.0
(-6 to 2)
Change at Day 8 Number Analyzed 108 participants 105 participants
-2.0
(-5 to 0)
-2.0
(-6 to 1)
Change at Day 11 Number Analyzed 102 participants 101 participants
-2.0
(-5 to 1)
-3.0
(-6 to 1)
Change at Day 15 Number Analyzed 99 participants 105 participants
-2.0
(-5 to 0)
-3.0
(-5 to 0)
Change at Day 18 Number Analyzed 94 participants 103 participants
-2.5
(-5 to 0)
-3.0
(-6 to 1)
Change at Day 22 Number Analyzed 91 participants 105 participants
-3.0
(-5 to 1)
-3.0
(-6 to 1)
Change at Day 25 Number Analyzed 93 participants 96 participants
-3.0
(-5 to 1)
-3.0
(-6 to 1)
6.Secondary Outcome
Title Number of Participants Who Achieved Resolution of Suicidality (CGI-SS-R Score of 0 or 1) Through Double-blind Phase
Hide Description CGI-SS-R was derived from the Clinical Global Impression Severity Scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participants illness. The CGI-SS-R rating is scored on a 7-point scale from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal participants). A higher score indicates a more severe condition. Negative change in score indicates improvement. A participant was considered to achieve resolution of suicidality at a given time point if the CGI-SS-R score was 0 (normal, not at all suicidal) or 1 (questionably suicidal).
Time Frame Days 1, 2, 4, 8, 11, 15, 18, 22 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during the double-blind phase and have had both a baseline and a post-baseline evaluation for the MADRS total score or CGI-SS-R.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1
25
  22.3%
37
  33.0%
Day 2
39
  34.8%
42
  37.5%
Day 4
45
  40.2%
49
  43.8%
Day 8
48
  42.9%
53
  47.3%
Day 11
46
  41.1%
60
  53.6%
Day 15
52
  46.4%
68
  60.7%
Day 18
55
  49.1%
68
  60.7%
Day 22
62
  55.4%
70
  62.5%
Day 25
57
  50.9%
71
  63.4%
7.Secondary Outcome
Title Change From Baseline in Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I) Scale Total Score at Days 1, 2, 4, 8, 11, 15, 18, 22 and 25 During Double-blind Phase
Hide Description The CGI-SR-I is a scale summarizing the clinician's best assessment of the likelihood that the participant will attempt suicide in the next 7 days. The CGI-SR-I rating is scored on a 7-point scale: where' 0 (no imminent suicide risk); 1 (minimal imminent suicide risk), 2 (mild imminent suicide risk), 3 (moderate imminent suicide risk), 4 (marked imminent suicide risk), 5 (severely imminent suicide risk), 6 (extreme imminent suicide risk). Higher score indicates a more severe condition. Negative change in score indicates improvement.
Time Frame Baseline and Days 1, 2, 4, 8, 11, 15, 18, 22 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase and have had both a baseline and a post-baseline evaluation for MADRS total score or CGI-SS-R. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified time points.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Median (Full Range)
Unit of Measure: units on a scale
Change at Day 1 Number Analyzed 112 participants 110 participants
0.0
(-4 to 2)
-1.0
(-5 to 3)
Change at Day 2 Number Analyzed 112 participants 112 participants
-1.0
(-5 to 2)
-1.0
(-5 to 2)
Change at Day 4 Number Analyzed 110 participants 110 participants
-1.0
(-5 to 2)
-2.0
(-5 to 2)
Change at Day 8 Number Analyzed 108 participants 105 participants
-2.0
(-5 to 2)
-2.0
(-6 to 1)
Change at Day 11 Number Analyzed 102 participants 101 participants
-2.0
(-5 to 1)
-2.0
(-6 to 1)
Change at Day 15 Number Analyzed 99 participants 105 participants
-2.0
(-5 to 2)
-3.0
(-5 to 2)
Change at Day 18 Number Analyzed 94 participants 103 participants
-3.0
(-5 to 1)
-3.0
(-5 to 2)
Change at Day 22 Number Analyzed 91 participants 105 participants
-3.0
(-5 to 1)
-3.0
(-6 to 1)
Change at Day 25 Number Analyzed 93 participants 96 participants
-3.0
(-5 to 2)
-3.0
(-6 to 1)
8.Secondary Outcome
Title Change From Baseline in Beck Hopelessness Scale (BHS) Total Score at Days 8 and 25 During Double-blind Phase
Hide Description BHS is a self-reported measure to assess one's level of negative expectations or pessimism regarding future. It consists of 20 true-false items that examine respondent's attitude over past week by either endorsing a pessimistic statement or denying an optimistic statement; 9 are keyed false and 11 are keyed true. For every statement, each response was assigned score of 0 or 1. Total BHS score is sum of item responses, ranged from 0-20, where higher score represented higher level of hopelessness.
Time Frame Baseline, Days 8 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase and have had both a baseline and a post-baseline evaluation for MADRS total score or CGI-SS-R. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified time points.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Day 8 Number Analyzed 108 participants 111 participants
-4.4  (6.03) -5.3  (6.06)
Change at Day 25 Number Analyzed 98 participants 105 participants
-6.6  (6.63) -6.9  (6.92)
9.Secondary Outcome
Title Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Days 2, 11 and 25 During Double-blind Phase: Health Status Index
Hide Description EQ-5D-5L measures health outcome. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-5D-5L system comprises following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of 5 dimensions is divided into 5 levels of perceived problems (Level 1-no problem, Level 2-slight problems, Level 3-moderate problems, Level 4-severe problems, Level 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a health status index (HSI). Health Status Index ranges from 0.148 - 0.949, anchored at 0 (dead) and 1 (full health). Positive change in score indicates improvement.
Time Frame Baseline and Days 2, 11 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase, have had both a baseline and a post-baseline evaluation for MADRS total score or CGI-SS-R. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified time points.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Day 2 Number Analyzed 110 participants 111 participants
0.096  (0.1785) 0.156  (0.1944)
Change at Day 11 Number Analyzed 107 participants 106 participants
0.169  (0.2139) 0.206  (0.2043)
Change at Day 25 Number Analyzed 97 participants 104 participants
0.189  (0.2336) 0.227  (0.2078)
10.Secondary Outcome
Title Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Days 2, 11 and 25 During Double-blind Phase: EQ-Visual Analogue Scale (EQ-VAS)
Hide Description EQ-5D-5L measures health outcome. It consists of EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS). EQ-VAS score from 0 (worst health) to 100 (best health), positive change in score indicates improvement.
Time Frame Baseline, Days 2, 11 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase, have had both a baseline and a post-baseline evaluation for MADRS total score or CGI-SS-R. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified time points.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Day 2 Number Analyzed 110 participants 111 participants
7.8  (17.32) 13.5  (20.78)
Change at Day 11 Number Analyzed 107 participants 106 participants
16.3  (22.27) 17.9  (24.55)
Change at Day 25 Number Analyzed 97 participants 104 participants
20.0  (23.49) 21.4  (26.71)
11.Secondary Outcome
Title Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Days 2, 11 and 25 During Double-blind Phase: Sum Score
Hide Description EQ-5D-5L measures health outcome. It consists of EQ-5D-5L system and EQ-VAS. EQ-5D-5L system comprises following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of 5 dimensions is divided into 5 levels of perceived problems (Level 1-no problem, Level 2-slight problems, Level 3-moderate problems, Level 4-severe problems, and Level 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a health status index (HSI). Health Status Index ranges from 0.148 - 0.949, anchored at 0 (dead) and 1 (full health), a lower score indicates worse health. Sum score=(sum of the scores from the 5 dimensions minus 5)*5. Sum score ranges from 0-100. Higher score indicates a more severe problem. Negative change in score indicates improvement.
Time Frame Baseline, Days 2, 11 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase, have had both a baseline and a post-baseline evaluation for MADRS total score or CGI-SS-R. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified time points.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Day 2 Number Analyzed 110 participants 111 participants
-6.1  (12.28) -11.2  (14.87)
Change at Day 11 Number Analyzed 107 participants 106 participants
-12.3  (16.23) -15.2  (15.75)
Change at Day 25 Number Analyzed 97 participants 104 participants
-13.4  (18.05) -16.8  (16.30)
12.Secondary Outcome
Title Change From Baseline in Quality of Life in Depression Scale (QLDS) Total Score at Days 2, 11 and 25 During Double-blind Phase
Hide Description The QLDS is a disease specific patient-reported outcome designed to assess health related quality of life in participants with major depressive disorder (MDD). The instrument has a recall period of "at the moment", contains 34-items with "true"/"not true" response options and takes approximately 5-10 minutes to complete. The total score range is from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition. Negative change indicates improvement.
Time Frame Baseline and Days 2, 11 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase and have had both a baseline and a post-baseline evaluation for MADRS total score or CGI-SS-R. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified time points.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Day 2 Number Analyzed 110 participants 112 participants
-2.5  (4.55) -3.1  (5.14)
Change at Day 11 Number Analyzed 107 participants 106 participants
-4.4  (5.93) -5.6  (5.92)
Change at Day 25 Number Analyzed 97 participants 104 participants
-5.6  (5.99) -6.8  (5.97)
13.Secondary Outcome
Title Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score at Days 15 and 25 During Double-blind Phase
Hide Description The TSQM-9 is a 9-item generic patient-reported outcome instrument to assess participants' satisfaction with medication. It covers domains of effectiveness, convenience, and global satisfaction. The TSQM-9 domain scores were calculated as recommended by the instrument authors. (i) Effectiveness = [(item 1 + item 2 + item 3) - 3]/18*100, (ii) Convenience = [(item 4 + item 5 + item 6) - 3]/18*100 and (iii) Global satisfaction = [(item 7 + item 8 + item 9) - 3]/14*100. Each domain score can be calculated only if all the three items considered in the calculation of that score are not missing. The TSQM-9 domain score ranges from 0 to 100, with higher scores representing higher satisfaction.
Time Frame Days 15 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase and have had both a baseline and a post-baseline evaluation for MADRS total score or CGI-SS-R. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified time points.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Effectiveness: Day 15 Number Analyzed 105 participants 108 participants
51.7  (25.74) 63.5  (23.72)
Effectiveness: Day 25 Number Analyzed 96 participants 102 participants
57.6  (24.66) 65.8  (25.23)
Convenience: Day 15 Number Analyzed 105 participants 108 participants
70.9  (19.57) 70.5  (20.75)
Convenience: Day 25 Number Analyzed 96 participants 102 participants
74.0  (19.38) 71.3  (19.69)
Global Satisfaction: Day 15 Number Analyzed 105 participants 108 participants
52.2  (28.57) 64.5  (24.62)
Global Satisfaction: Day 25 Number Analyzed 96 participants 102 participants
55.7  (27.44) 68.5  (25.51)
14.Secondary Outcome
Title Change From Baseline in Suicide Ideation and Behavior Assessment Tool (SIBAT) Module 5 (My Risk) Question 3 (Patient-reported FoST) Total Score at Days 1, 2, 4, 8, 11, 15, 18, 22 and 25 During Double-blind Phase
Hide Description SIBAT is an assessment tool that captures suicidal ideation, behavior, and risk. It permits assessment of change in suicidal ideation and behavior and documents clinician assessment of severity of suicidality and suicide risk. SIBAT is organized into 8 modules divided into 2 major divisions: patient-reported section (Modules 1-5) and clinician-rated section (Modules 6-8). Patient-reported section has modules of demographics and suicide history, risk/protective factors, suicidal thinking, suicide behavior, and suicide risk. Question 3 from Module 5 asks participants to describe their thinking about suicide right now from 5 response options ranging from 0 (I have no suicidal thoughts) to 4 (I have suicidal thoughts all of time). SIBAT Module 5 (My Risk) Question 3 (Patient-reported FoST) total score ranges from 0 to 4; a higher score indicates a more severe condition. Negative change in score indicates improvement.
Time Frame Baseline, Days 1, 2, 4, 8, 11, 15, 18, 22 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase and have had both a baseline and a post-baseline evaluation for MADRS total score or CGI-SS-R. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified time points.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Median (Full Range)
Unit of Measure: units on a scale
Change at Day 1 Number Analyzed 111 participants 110 participants
0.0
(-4 to 2)
0.0
(-3 to 1)
Change at Day 2 Number Analyzed 111 participants 110 participants
-1.0
(-4 to 1)
-1.0
(-4 to 2)
Change at Day 4 Number Analyzed 110 participants 108 participants
-1.0
(-4 to 2)
-1.0
(-4 to 1)
Change at Day 8 Number Analyzed 108 participants 104 participants
-1.0
(-4 to 1)
-1.0
(-4 to 1)
Change at Day 11 Number Analyzed 103 participants 100 participants
-1.0
(-4 to 1)
-1.5
(-4 to 1)
Change at Day 15 Number Analyzed 100 participants 104 participants
-1.0
(-4 to 1)
-2.0
(-4 to 1)
Change at Day 18 Number Analyzed 94 participants 101 participants
-2.0
(-4 to 1)
-2.0
(-4 to 1)
Change at Day 22 Number Analyzed 92 participants 104 participants
-2.0
(-4 to 2)
-2.0
(-4 to 1)
Change at Day 25 Number Analyzed 93 participants 96 participants
-2.0
(-4 to 1)
-2.0
(-4 to 1)
15.Secondary Outcome
Title Change From Baseline in Suicide Ideation and Behavior Assessment Tool (SIBAT) Module 7 - Clinician-rated FoST Total Score at Days 1, 2, 4, 8, 11, 15, 18, 22 and 25 During Double-blind Phase
Hide Description SIBAT is assessment tool that captures suicidal ideation, behavior, and risk. It permits assessment of change in suicidal ideation and behavior and documents clinician assessment of severity of suicidality and suicide risk. SIBAT has 8 modules divided into 2 major divisions: patient-reported section (Modules 1-5) and clinician-rated section (Modules 6-8). Clinician-rated section has modules for semi-structured interview, clinical global impressions of current severity of suicidality and imminent suicide risk, clinical global impression of long-term suicide risk, and clinical judgment of optimal suicide management. The score anchor point as in participant report frequency of suicidal thinking (FoST) that is, response options from never to all the time. Module 7-FoST score ranges from 0-5; higher score indicates more severe condition. Negative change in score indicates improvement.
Time Frame Baseline and Days 1, 2, 4, 8, 11, 15, 18, 22 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Full efficacy analysis set included all randomized participants who received at least 1 dose of intranasal study agent during double-blind phase and have had both a baseline and a post-baseline evaluation for MADRS total score or CGI-SS-R. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified time points.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 112
Median (Full Range)
Unit of Measure: units on a scale
Change at Day 1 Number Analyzed 112 participants 109 participants
-1.0
(-5 to 2)
-1.0
(-5 to 1)
Change at Day 2 Number Analyzed 112 participants 112 participants
-1.0
(-5 to 1)
-1.0
(-5 to 1)
Change at Day 4 Number Analyzed 110 participants 109 participants
-1.0
(-5 to 1)
-2.0
(-5 to 2)
Change at Day 8 Number Analyzed 108 participants 104 participants
-2.0
(-5 to 2)
-2.0
(-5 to 1)
Change at Day 11 Number Analyzed 102 participants 100 participants
-2.0
(-5 to 2)
-2.0
(-5 to 2)
Change at Day 15 Number Analyzed 99 participants 104 participants
-2.0
(-5 to 0)
-2.0
(-5 to 1)
Change at Day 18 Number Analyzed 94 participants 102 participants
-2.0
(-5 to 1)
-2.0
(-5 to 1)
Change at Day 22 Number Analyzed 91 participants 104 participants
-2.0
(-5 to 1)
-2.0
(-5 to 1)
Change at Day 25 Number Analyzed 93 participants 95 participants
-2.0
(-5 to 1)
-3.0
(-5 to 1)
16.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs): DB Treatment Phase
Hide Description An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE is categorized as related if assessed by the investigator as possibly, probably, or very likely related to study agent.
Time Frame Up to Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of study drug in the DB treatment phase.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 113
Measure Type: Count of Participants
Unit of Measure: Participants
83
  74.1%
100
  88.5%
17.Secondary Outcome
Title Number of Participants With Treatment Emergent Abnormal Laboratory Values: DB Treatment Phase
Hide Description Low/high abnormal values are: Alanine aminotransferase (ALT)-high=200 Units per liter(U/L); ALP-high=250U/L; aspartate aminotransferase(AST)-high=250U/L; gamma glutamyl transferase(GGT)=300U/L; Albumin(low=24g/L,high=60 g/L); Bicarbonate(low=15.1, high=34.9mmol/L); Bilirubin(high=51.3micromol/L); calcium(low=1.5,high=3mmol/L);Chloride(low=94,high=112mmol/L); CK(High=990U/L); Creatinine(High=265.2micromol/L); Eosinophils(High=10%); Erythrocytes(low=3.0*1012/L,high=6.4*1012/L); Glucose(low=2.2,high=16.7mmol/L); Hemoglobin(low=80g/L,high=190g/L);Hematocrit(low=0.28, high=0.55 fraction); LD(high=500U/L); Leukocytes(low=2.5*109/L,high=15.5*109/L); Lymphocytes(low=10%,high=60%); Monocytes(high=20%); Neutrophils(low=30%,high=90%); Phosphate(low=0.7 mmol/L,high=2.6mmol/L); Platelet count(low=100*109/L,high=600*109/L]; Potassium(low=3.0mmol/L,high=5.8 mmol/L]; Protein(low=50 g/L); Sodium(low=125 mmol/L,high=155 mmol/L); Urate(low=89.2 micromol/L,high=594.8micromol/L); Urine(high=8.0 pH).
Time Frame Up to Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of study drug in the DB treatment phase. Here 'n' (number analyzed) signifies number of participants analyzed for each specified category.ULN=upper limit of normal; mmol/L= millimoles per liter; micromol/L=micromole/liter; g/L=gram per liter
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 113
Measure Type: Count of Participants
Unit of Measure: Participants
ALT>3*ULN Number Analyzed 100 participants 109 participants
1
   1.0%
1
   0.9%
ALT: Abnormal High Number Analyzed 100 participants 109 participants
1
   1.0%
1
   0.9%
Albumin: Abnormal High Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Albumin: Abnormal Low Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Alkaline phosphatase (ALP): Abnormal High Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
AST: AST>3*ULN Number Analyzed 100 participants 108 participants
0
   0.0%
0
   0.0%
AST: Abnormal High Number Analyzed 100 participants 108 participants
0
   0.0%
0
   0.0%
Bicarbonate: Abnormal High Number Analyzed 99 participants 109 participants
0
   0.0%
0
   0.0%
Bicarbonate: Abnormal Low Number Analyzed 99 participants 109 participants
0
   0.0%
0
   0.0%
Bilirubin: Abnormal High Number Analyzed 100 participants 109 participants
0
   0.0%
0
   0.0%
Calcium: Abnormal High Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Calcium: Abnormal Low Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Chloride: Abnormal High Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Chloride: Abnormal Low Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Creatine Kinase (CK): Abnormal High Number Analyzed 100 participants 109 participants
0
   0.0%
1
   0.9%
Creatinine: Abnormal High Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
GGT: Abnormal High Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Glucose: Abnormal High Number Analyzed 100 participants 109 participants
0
   0.0%
0
   0.0%
Glucose: Abnormal Low Number Analyzed 100 participants 109 participants
0
   0.0%
0
   0.0%
ALT>3*ULN or AST>3*ULN and BILI>2*ULN Number Analyzed 100 participants 109 participants
0
   0.0%
0
   0.0%
Lactate Dehydrogenase(LD): Abnormal High Number Analyzed 94 participants 101 participants
0
   0.0%
0
   0.0%
Phosphate: Abnormal High Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Phosphate: Abnormal Low Number Analyzed 102 participants 110 participants
1
   1.0%
2
   1.8%
Potassium: Abnormal High Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Potassium: Abnormal Low Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Protein: Abnormal Low Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Sodium: Abnormal High Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Sodium: Abnormal Low Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Urate: Abnormal High Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Urate: Abnormal Low Number Analyzed 102 participants 110 participants
0
   0.0%
0
   0.0%
Basophils: Abnormal High Number Analyzed 97 participants 105 participants
0
   0.0%
0
   0.0%
Eosinophils: Abnormal High Number Analyzed 97 participants 105 participants
0
   0.0%
0
   0.0%
Erythrocytes: Abnormal High Number Analyzed 97 participants 105 participants
1
   1.0%
1
   1.0%
Erythrocytes: Abnormal Low Number Analyzed 97 participants 105 participants
0
   0.0%
0
   0.0%
Hematocrit: Abnormal High Number Analyzed 96 participants 103 participants
0
   0.0%
0
   0.0%
Hematocrit: Abnormal Low Number Analyzed 96 participants 103 participants
0
   0.0%
0
   0.0%
Hemoglobin(Hb): Abnormal High Number Analyzed 97 participants 105 participants
0
   0.0%
0
   0.0%
Hemoglobin: Abnormal Low Number Analyzed 97 participants 105 participants
0
   0.0%
0
   0.0%
Leukocytes: Abnormal High Number Analyzed 97 participants 105 participants
0
   0.0%
0
   0.0%
Leukocytes: Abnormal Low Number Analyzed 97 participants 105 participants
1
   1.0%
0
   0.0%
Lymphocytes: Abnormal High Number Analyzed 97 participants 105 participants
0
   0.0%
0
   0.0%
Lymphocytes: Abnormal Low Number Analyzed 97 participants 105 participants
0
   0.0%
0
   0.0%
Monocytes: Abnormal High Number Analyzed 97 participants 105 participants
0
   0.0%
0
   0.0%
Neutrophils: Abnormal High Number Analyzed 97 participants 105 participants
0
   0.0%
0
   0.0%
Neutrophils: Abnormal Low Number Analyzed 97 participants 105 participants
0
   0.0%
0
   0.0%
Platelets: Abnormal High Number Analyzed 97 participants 104 participants
0
   0.0%
0
   0.0%
Platelets: Abnormal Low Number Analyzed 97 participants 104 participants
0
   0.0%
2
   1.9%
Urine pH: Abnormal High Number Analyzed 102 participants 109 participants
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title Number of Participants With Abnormal Nasal Examinations at Day 25: DB Treatment Phase
Hide Description Number of participants with abnormal nasal examination were reported. Nasal examination of visual inspection of the epistaxis, nasal crusts, nasal discharge, and nasal erythema was performed.
Time Frame At Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of study drug in the DB treatment phase. Here, 'n' (number analyzed) signifies number of participants analyzed for each specified category.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 113
Measure Type: Count of Participants
Unit of Measure: Participants
Epistaxis: Mild Number Analyzed 104 participants 109 participants
0
   0.0%
1
   0.9%
Epistaxis: Moderate Number Analyzed 104 participants 109 participants
0
   0.0%
0
   0.0%
Epistaxis: Severe Number Analyzed 104 participants 109 participants
0
   0.0%
0
   0.0%
Nasal Crusts: Mild Number Analyzed 104 participants 109 participants
1
   1.0%
0
   0.0%
Nasal Crusts: Moderate Number Analyzed 104 participants 109 participants
0
   0.0%
0
   0.0%
Nasal Crusts: Severe Number Analyzed 104 participants 109 participants
0
   0.0%
0
   0.0%
Nasal Discharge: Mild Number Analyzed 104 participants 109 participants
0
   0.0%
3
   2.8%
Nasal Discharge: Moderate Number Analyzed 104 participants 109 participants
0
   0.0%
0
   0.0%
Nasal Discharge: Severe Number Analyzed 104 participants 109 participants
0
   0.0%
0
   0.0%
Nasal Erythema: Mild Number Analyzed 104 participants 109 participants
4
   3.8%
3
   2.8%
Nasal Erythema: Moderate Number Analyzed 104 participants 109 participants
0
   0.0%
0
   0.0%
Nasal Erythema: Severe Number Analyzed 104 participants 109 participants
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number of Participants With Treatment Emergent Abnormal Electrocardiogram (ECG) Values at Any Time: DB Treatment Phase
Hide Description Number of participants with treatment emergent abnormal ECG values for variables including heart rate (abnormally low refers to less than or equal to [<=] 50 beats per minute [bpm] , abnormally high refers greater than or equal to [>=] 100 bpm), pulse rate (PR) interval (abnormally high refers to >= 210 milliseconds [msec]), QRS interval (abnormally Low refers to <= 50, abnormally high refers to >= 120 msec) and QT interval (abnormally low refers to <= 200, abnormally high >= 500 msec) were reported.
Time Frame Up to Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of study drug in the DB treatment phase.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 113
Measure Type: Count of Participants
Unit of Measure: Participants
Heart Rate <= 50 bpm
8
   7.1%
2
   1.8%
Heart Rate >= 100 bpm
4
   3.6%
5
   4.4%
PR Duration >= 210 msec
3
   2.7%
5
   4.4%
QRS Duration <= 50 msec
0
   0.0%
0
   0.0%
QRS Duration >= 120 msec
0
   0.0%
0
   0.0%
QT Duration <= 200 msec
0
   0.0%
0
   0.0%
QT Duration >= 500 msec
0
   0.0%
0
   0.0%
20.Secondary Outcome
Title Number of Participants With Abnormal Arterial Oxygen Saturation (SpO2) Levels (Less Than [<] 93%) as Assessed by Pulse Oximetry at Any Time: DB Treatment Phase
Hide Description Pulse oximetry was used to measure arterial SpO2 levels. On each dosing day, the device was attached to the finger, toe, or ear, and SpO2 was monitored and documented. If oxygen saturation levels were less than (<) 93% at any time during the 1.5 hours postdose interval, pulse oximetry was recorded every 5 minutes until levels return to >= 93% or until the participant is referred for appropriate medical care, if clinically indicated. Participants with at least 2 consecutive postdose oxygen saturation below 93% during the DB treatment phase were reported.
Time Frame Up to Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of study drug in the DB treatment phase.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 113
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.8%
1
   0.9%
21.Secondary Outcome
Title Number of Participants With Treatment Emergent Vital Signs Abnormalities: DB Treatment Phase
Hide Description Number of participants with treatment emergent vital signs abnormalities (pulse rate in bpm [abnormally low = a decrease from baseline of >= 15 to a value <= 50; abnormally high = an increase from baseline of >=15 to a value >=100] , systolic blood pressure [SBP] in mmHg [abnormally low = a decrease from baseline of >= 20 to a value <= 90; abnormally high = an increase from baseline of >= 20 to a value >= 180], and diastolic blood pressure [DBP] in mmHg [abnormally low= a decrease from baseline of >=15 to a value <= 50; abnormally high = an increase from baseline of >= 15 to a value >= 105) were reported.
Time Frame Up to Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of study drug in the DB treatment phase.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 113
Measure Type: Count of Participants
Unit of Measure: Participants
Pulse rate (bpm): Decrease of >=15 to <=50
2
   1.8%
3
   2.7%
Pulse rate (bpm): Increase of >=15 to >=100
6
   5.4%
13
  11.5%
SBP (mmHg): Decrease of >=20 to <=90
4
   3.6%
0
   0.0%
SBP (mmHg): Increase of >=20 to >=180
0
   0.0%
2
   1.8%
DBP (mmHg): Decrease of >=15 to <=50
4
   3.6%
0
   0.0%
DBP (mmHg): Increase of >=15 to >=105
1
   0.9%
11
   9.7%
22.Secondary Outcome
Title Number of Sedated Participants as Assessed by Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score at Any Time: DB Treatment Phase
Hide Description MOAA/S was 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 to 5 where,0 = no response to painful stimulus; ASA continuum = general anesthesia, 1 = responds to trapezius squeeze; ASA continuum = deep sedation, 2 = purposeful response to mild prodding or mild shaking; ASA continuum = moderate sedation, 3 = responds after name called loudly or repeatedly; ASA continuum = moderate sedation, 4 = lethargic response to name spoken in normal tone; ASA continuum = moderate sedation and 5 = readily responds to name spoken in normal tone (awake); ASA continuum = minimal sedation.
Time Frame Up to Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of study drug in the DB treatment phase.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 113
Measure Type: Count of Participants
Unit of Measure: Participants
Score <=2: Yes
0
   0.0%
3
   2.7%
Score <=3: Yes
1
   0.9%
13
  11.5%
Score <=4: Yes
20
  17.9%
43
  38.1%
23.Secondary Outcome
Title Number of Participants With an Increase in Clinician-administered Dissociative States Scale (CADSS) Total Score Over Time: DB Treatment Phase
Hide Description The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = "Not at all", 1 = "Mild", 2 = "Moderate", 3 = 'Severe" and 4 = "Extreme"). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition. Number of participants with an increase in CADSS total score (increase based on maximum CADSS total score change from predose of > 0) was reported.
Time Frame Days 1, 4, 8, 11, 15, 18, 22 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of study drug in the DB treatment phase. Here, 'n' (number analyzed) signifies the number of participants analyzed for each specified time point.
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description:
Participants self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1.
Participants self-administered esketamine 84 milligrams (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) and received SOC antidepressant treatment which was initiated or optimized on Day 1.
Overall Number of Participants Analyzed 112 113
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 111 participants 113 participants
34
  30.6%
95
  84.1%
Day 4 Number Analyzed 107 participants 106 participants
23
  21.5%
84
  79.2%
Day 8 Number Analyzed 108 participants 108 participants
29
  26.9%
81
  75.0%
Day 11 Number Analyzed 101 participants 100 participants
19
  18.8%
77
  77.0%
Day 15 Number Analyzed 97 participants 105 participants
17
  17.5%
69
  65.7%
Day 18 Number Analyzed 92 participants 102 participants
19
  20.7%
70
  68.6%
Day 22 Number Analyzed 93 participants 102 participants
16
  17.2%
70
  68.6%
Day 25 Number Analyzed 91 participants 98 participants
14
  15.4%
72
  73.5%
Time Frame Up to Day 25
Adverse Event Reporting Description Safety analysis set included all randomized participants who received at least 1 dose of study agent in the double-blind treatment phase.
 
Arm/Group Title Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Hide Arm/Group Description Subjects self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1 during double blind phase (DB). Subjects self-administered esketamine 84 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received SOC antidepressant treatment which was initiated or optimized on Day 1 during double blind phase.
All-Cause Mortality
Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)   0/113 (0.00%) 
Hide Serious Adverse Events
Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   6/112 (5.36%)   4/113 (3.54%) 
Hepatobiliary disorders     
Hypertransaminasaemia * 1  1/112 (0.89%)  0/113 (0.00%) 
Metabolism and nutrition disorders     
Diabetic Ketoacidosis * 1  0/112 (0.00%)  1/113 (0.88%) 
Psychiatric disorders     
Aggression * 1  1/112 (0.89%)  0/113 (0.00%) 
Depression * 1  1/112 (0.89%)  1/113 (0.88%) 
Depression Suicidal * 1  1/112 (0.89%)  2/113 (1.77%) 
Suicidal Ideation * 1  2/112 (1.79%)  0/113 (0.00%) 
Suicide Attempt * 1  1/112 (0.89%)  1/113 (0.88%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Plus SOC Antidepressant Treatment Esketamine 84 mg Plus SOC Antidepressant Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   66/112 (58.93%)   91/113 (80.53%) 
Ear and labyrinth disorders     
Vertigo * 1  1/112 (0.89%)  7/113 (6.19%) 
Eye disorders     
Vision Blurred * 1  5/112 (4.46%)  10/113 (8.85%) 
Gastrointestinal disorders     
Constipation * 1  5/112 (4.46%)  15/113 (13.27%) 
Nausea * 1  15/112 (13.39%)  23/113 (20.35%) 
Vomiting * 1  7/112 (6.25%)  8/113 (7.08%) 
Investigations     
Blood Pressure Increased * 1  6/112 (5.36%)  19/113 (16.81%) 
Nervous system disorders     
Dizziness * 1  10/112 (8.93%)  40/113 (35.40%) 
Dizziness Postural * 1  2/112 (1.79%)  6/113 (5.31%) 
Dysgeusia * 1  11/112 (9.82%)  16/113 (14.16%) 
Headache * 1  20/112 (17.86%)  21/113 (18.58%) 
Hypoaesthesia * 1  2/112 (1.79%)  8/113 (7.08%) 
Sedation * 1  2/112 (1.79%)  7/113 (6.19%) 
Somnolence * 1  11/112 (9.82%)  21/113 (18.58%) 
Psychiatric disorders     
Anxiety * 1  10/112 (8.93%)  6/113 (5.31%) 
Dissociation * 1  4/112 (3.57%)  33/113 (29.20%) 
Insomnia * 1  7/112 (6.25%)  7/113 (6.19%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
Esketamine's known characteristic effects such as dissociative symptoms, sedation, and elevation of blood pressure may have impact on blinding, to minimize this bias, protocol specified that different raters perform efficacy and safety assessments.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03039192    
Other Study ID Numbers: CR108284
2016-003990-17 ( EudraCT Number )
54135419SUI3001 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: January 31, 2017
First Posted: February 1, 2017
Results First Submitted: September 1, 2020
Results First Posted: October 29, 2020
Last Update Posted: October 29, 2020