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Trial record 25 of 49 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Belgium )

A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression (TRANSFORM-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02422186
Recruitment Status : Completed
First Posted : April 21, 2015
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
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, Treatment-Resistant
Interventions Drug: Esketamine
Drug: Placebo
Drug: Duloxetine (Oral Antidepressant)
Drug: Escitalopram (Oral Antidepressant)
Drug: Sertraline (Oral Antidepressant)
Drug: Venlafaxine Extended Release (XR) (New Antidepressant)
Enrollment 139
Recruitment Details  
Pre-assignment Details Total 139 participants were enrolled, out of which 138 were randomized and 1 participant was excluded due to Good Clinical Practice (GCP) non-compliance.
Arm/Group Title Intranasal Esketamine Plus Oral Antidepressant (AD) Oral AD Plus Intranasal Placebo
Hide Arm/Group Description Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg plus oral AD in DB induction phase were continued to follow-up phase for 2 weeks. Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day-Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day-Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day-Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day-Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo plus oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Period Title: Double-blind Induction Phase (4 Weeks)
Started 72 66
Full Analysis Set (FAS) 72 65
Safety Analysis Set 72 65
Completed 62 60
Not Completed 10 6
Reason Not Completed
Lost to Follow-up             1             0
Protocol Violation             0             1
Withdrawal by Subject             1             2
Lack of Efficacy             3             1
Adverse Event             4             2
Other             1             0
Period Title: Follow-up Phase (2 Weeks)
Started 12 3
Completed 8 3
Not Completed 4 0
Reason Not Completed
Withdrawal by Subject             1             0
Other             3             0
Arm/Group Title Intranasal Esketamine Plus Oral Antidepressant (AD) Oral AD Plus Intranasal Placebo Total
Hide Arm/Group Description Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks. Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 72 65 137
Hide Baseline Analysis Population Description
The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 65 participants 137 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
72
 100.0%
65
 100.0%
137
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 65 participants 137 participants
70.6  (4.79) 69.4  (4.15) 70  (4.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 65 participants 137 participants
Female
45
  62.5%
40
  61.5%
85
  62.0%
Male
27
  37.5%
25
  38.5%
52
  38.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 65 participants 137 participants
Hispanic or Latino
10
  13.9%
5
   7.7%
15
  10.9%
Not Hispanic or Latino
59
  81.9%
59
  90.8%
118
  86.1%
Unknown or Not Reported
3
   4.2%
1
   1.5%
4
   2.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 65 participants 137 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
66
  91.7%
64
  98.5%
130
  94.9%
More than one race
4
   5.6%
0
   0.0%
4
   2.9%
Unknown or Not Reported
2
   2.8%
1
   1.5%
3
   2.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 65 participants 137 participants
Belgium
2
   2.8%
4
   6.2%
6
   4.4%
Brazil
1
   1.4%
0
   0.0%
1
   0.7%
Bulgaria
3
   4.2%
0
   0.0%
3
   2.2%
Finland
1
   1.4%
1
   1.5%
2
   1.5%
France
4
   5.6%
3
   4.6%
7
   5.1%
Italy
6
   8.3%
3
   4.6%
9
   6.6%
Lithuania
2
   2.8%
0
   0.0%
2
   1.5%
Poland
4
   5.6%
3
   4.6%
7
   5.1%
South Africa
2
   2.8%
5
   7.7%
7
   5.1%
Spain
4
   5.6%
4
   6.2%
8
   5.8%
Sweden
8
  11.1%
6
   9.2%
14
  10.2%
United Kingdom
1
   1.4%
0
   0.0%
1
   0.7%
United States
34
  47.2%
36
  55.4%
70
  51.1%
1.Primary Outcome
Title Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis
Hide Description The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items (to evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel [interest level], pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0-60. Higher scores represent a more severe condition. Negative change in score indicates improvement.
Time Frame Baseline up to Endpoint (Double-blind Induction Phase[Day 28])
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Intranasal Esketamine Plus Oral Antidepressant (AD) Oral AD Plus Intranasal Placebo
Hide Arm/Group Description:
Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-10.0  (12.74) -6.3  (8.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intranasal Esketamine Plus Oral Antidepressant (AD), Oral AD Plus Intranasal Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.029
Comments [Not Specified]
Method Mixed Model for Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of Least Square (LS) Means
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-7.20 to 0.07
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis
Hide Description The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items (to evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel [interest level], pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0-60. Higher scores represent a more severe condition. Negative change in score indicates improvement. Missing data was imputed using Last Observation Carried Forward (LOCF) method and last post baseline observation during the double-blind induction phase was carried forward as the “End Point” for that phase.
Time Frame Baseline and Endpoint (Double-blind Induction Phase [Day 28])
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Intranasal Esketamine Plus Oral Antidepressant (AD) Oral AD Plus Intranasal Placebo
Hide Arm/Group Description:
Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Overall Number of Participants Analyzed 71 64
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-9.3  (12.28) -5.6  (9.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intranasal Esketamine Plus Oral Antidepressant (AD), Oral AD Plus Intranasal Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.026
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-7.16 to -0.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)
Hide Description Percentage of participants with greater than or equal to (>=50) percent (%) reduction from baseline are reported. 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. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the “End Point” for that phase.
Time Frame At Endpoint-Double-blind Induction Phase [Day 28]
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Intranasal Esketamine Plus Oral Antidepressant (AD) Oral AD Plus Intranasal Placebo
Hide Arm/Group Description:
Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Overall Number of Participants Analyzed 71 64
Measure Type: Number
Unit of Measure: Percentage of Participants
23.9 12.5
4.Secondary Outcome
Title Percentage of Participants in Remission (MADRS<=12) at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)
Hide Description Remission was defined as participants who had a MADRS total score of less than or equal to (=<) 12. 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. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the “End Point” for that phase.
Time Frame At Endpoint-Double-blind Induction Phase [Day 28]
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Intranasal Esketamine Plus Oral Antidepressant (AD) Oral AD Plus Intranasal Placebo
Hide Arm/Group Description:
Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Overall Number of Participants Analyzed 71 64
Measure Type: Number
Unit of Measure: Percentage of Participants
15.5 6.3
5.Secondary Outcome
Title Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis on Ranks
Hide Description CGI-S provides an overall clinician-determined summary measure of the severity of the participants illness including participants history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participants ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the “End Point” for that phase.
Time Frame Baseline and Endpoint (Double-blind Induction Phase [Day 28])
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Intranasal Esketamine Plus Oral Antidepressant (AD) Oral AD Plus Intranasal Placebo
Hide Arm/Group Description:
Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Overall Number of Participants Analyzed 71 65
Median (Full Range)
Unit of Measure: Units on a scale
-1.0
(-4 to 1)
0.0
(-4 to 3)
6.Secondary Outcome
Title Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Health Status Index
Hide Description EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 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). HSI ranges from -0.148 (health state value equal to dead) and 0.949 (full health), is anchored at 0 (dead) and 1 (full health).
Time Frame Baseline and Endpoint (Double-blind Induction Phase [Day 28])
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Intranasal Esketamine Plus Oral Antidepressant (AD) Oral AD Plus Intranasal Placebo
Hide Arm/Group Description:
Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Overall Number of Participants Analyzed 70 64
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.081  (0.2624) 0.026  (0.2235)
7.Secondary Outcome
Title Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): EQ-VAS
Hide Description EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent’s own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Time Frame Baseline and Endpoint (Double-blind Induction Phase [Day 28])
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Intranasal Esketamine Plus Oral Antidepressant (AD) Oral AD Plus Intranasal Placebo
Hide Arm/Group Description:
Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Overall Number of Participants Analyzed 70 64
Mean (Standard Deviation)
Unit of Measure: Units on a scale
6.2  (22.78) 4.4  (20.60)
8.Secondary Outcome
Title Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Sum Score
Hide Description EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 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). HSI ranges from -0.148 (health state value equal to dead) and 0.949 (full health). EQ VAS self-rating records the respondent’s own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state.
Time Frame Baseline and Endpoint (Double-blind Induction Phase [Day 28])
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Intranasal Esketamine Plus Oral Antidepressant (AD) Oral AD Plus Intranasal Placebo
Hide Arm/Group Description:
Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
Overall Number of Participants Analyzed 70 64
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-6.6  (20.53) -1.6  (16.21)
Time Frame Up to 13 weeks
Adverse Event Reporting Description The population analyzed included safety analysis set- all randomized participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant medication during the double-blind induction phase and follow-up analysis set- all participants who entered the follow-up phase.
 
Arm/Group Title DB Phase: Intranasal Esketamine + Oral AD (4 Weeks) DB Phase: Oral AD + Intranasal Placebo (4 Weeks) Follow-up Phase: Intranasal Esketamine + Oral AD (2 Weeks) Follow-up Phase: Oral AD + Intranasal Placebo (2 Weeks)
Hide Arm/Group Description Participants self-administered esketamine 28 milligram (mg) or 56 mg or 84 mg intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in DB induction phase. Also, participants initiated titration schedule for open-label oral AD with one of following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with MDT at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine extended release (XR) (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants self-administered esketamine matched placebo intranasally twice weekly for 4 weeks (Day 1, 4, 8, 11, 15, 18, 22, 25) in double-blind (DB) induction phase. Also, participants initiated titration schedule for open-label oral antidepressant (AD) with one of the following: [Duloxetine (30 mg/day- Week 1, 60 mg/day- Weeks 2, 3 and 4 with minimum dose for tolerability (MDT) at 30 mg/day); Escitalopram (10 mg/day- Weeks 1-4 with MDT at 5 mg/day); Sertraline (25 mg/day- Week 1, 50 mg/day- Week 2, 100 mg/day- Week 3, 150 mg/day- Week 4 with MDT of 25 mg/Day) or Venlafaxine XR (37.5 mg/day- Week 1, 75 mg/day- Week 2, 150 mg/day- Weeks 3, 4 with MDT of 75 mg/day)] in DB induction phase. Participants who withdrew early, before end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal esketamine 28 mg or 56 mg or 84 mg+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks. Participants who withdrew early, before the end of DB induction phase, or chose not to participate in ESKETINTRD3004 (NCT02497287) long-term safety and efficacy study, and had received at least 1 dose of intranasal placebo+ oral AD in DB induction phase were continued to follow-up phase for 2 weeks.
All-Cause Mortality
DB Phase: Intranasal Esketamine + Oral AD (4 Weeks) DB Phase: Oral AD + Intranasal Placebo (4 Weeks) Follow-up Phase: Intranasal Esketamine + Oral AD (2 Weeks) Follow-up Phase: Oral AD + Intranasal Placebo (2 Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/72 (0.00%)   0/65 (0.00%)   0/12 (0.00%)   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
DB Phase: Intranasal Esketamine + Oral AD (4 Weeks) DB Phase: Oral AD + Intranasal Placebo (4 Weeks) Follow-up Phase: Intranasal Esketamine + Oral AD (2 Weeks) Follow-up Phase: Oral AD + Intranasal Placebo (2 Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/72 (4.17%)   2/65 (3.08%)   0/12 (0.00%)   0/3 (0.00%) 
General disorders         
Gait Disturbance * 1  0/72 (0.00%)  1/65 (1.54%)  0/12 (0.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications         
Hip Fracture * 1  1/72 (1.39%)  0/65 (0.00%)  0/12 (0.00%)  0/3 (0.00%) 
Investigations         
Blood Pressure Increased * 1  1/72 (1.39%)  0/65 (0.00%)  0/12 (0.00%)  0/3 (0.00%) 
Nervous system disorders         
Dizziness * 1  0/72 (0.00%)  1/65 (1.54%)  0/12 (0.00%)  0/3 (0.00%) 
Psychiatric disorders         
Anxiety Disorder * 1  1/72 (1.39%)  0/65 (0.00%)  0/12 (0.00%)  0/3 (0.00%) 
Feeling of Despair * 1  0/72 (0.00%)  1/65 (1.54%)  0/12 (0.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DB Phase: Intranasal Esketamine + Oral AD (4 Weeks) DB Phase: Oral AD + Intranasal Placebo (4 Weeks) Follow-up Phase: Intranasal Esketamine + Oral AD (2 Weeks) Follow-up Phase: Oral AD + Intranasal Placebo (2 Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/72 (61.11%)   22/65 (33.85%)   1/12 (8.33%)   1/3 (33.33%) 
Ear and labyrinth disorders         
Vertigo * 1  8/72 (11.11%)  2/65 (3.08%)  0/12 (0.00%)  0/3 (0.00%) 
Eye disorders         
Eye Pruritus * 1  0/72 (0.00%)  1/65 (1.54%)  0/12 (0.00%)  1/3 (33.33%) 
Gastrointestinal disorders         
Constipation * 1  0/72 (0.00%)  0/65 (0.00%)  1/12 (8.33%)  0/3 (0.00%) 
Hypoaesthesia Oral * 1  5/72 (6.94%)  0/65 (0.00%)  0/12 (0.00%)  0/3 (0.00%) 
Nausea * 1  13/72 (18.06%)  3/65 (4.62%)  0/12 (0.00%)  0/3 (0.00%) 
Vomiting * 1  5/72 (6.94%)  1/65 (1.54%)  0/12 (0.00%)  1/3 (33.33%) 
General disorders         
Fatigue * 1  9/72 (12.50%)  5/65 (7.69%)  0/12 (0.00%)  0/3 (0.00%) 
Infections and infestations         
Urinary Tract Infection * 1  6/72 (8.33%)  1/65 (1.54%)  0/12 (0.00%)  0/3 (0.00%) 
Investigations         
Blood Pressure Increased * 1  9/72 (12.50%)  3/65 (4.62%)  0/12 (0.00%)  0/3 (0.00%) 
Nervous system disorders         
Dizziness * 1  15/72 (20.83%)  4/65 (6.15%)  0/12 (0.00%)  0/3 (0.00%) 
Dysgeusia * 1  4/72 (5.56%)  3/65 (4.62%)  0/12 (0.00%)  0/3 (0.00%) 
Headache * 1  9/72 (12.50%)  2/65 (3.08%)  0/12 (0.00%)  0/3 (0.00%) 
Hypoaesthesia * 1  4/72 (5.56%)  1/65 (1.54%)  0/12 (0.00%)  0/3 (0.00%) 
Paraesthesia * 1  4/72 (5.56%)  2/65 (3.08%)  0/12 (0.00%)  0/3 (0.00%) 
Psychiatric disorders         
Anxiety * 1  2/72 (2.78%)  5/65 (7.69%)  0/12 (0.00%)  0/3 (0.00%) 
Dissociation * 1  9/72 (12.50%)  1/65 (1.54%)  0/12 (0.00%)  0/3 (0.00%) 
Dysphoria * 1  4/72 (5.56%)  0/65 (0.00%)  0/12 (0.00%)  0/3 (0.00%) 
Insomnia * 1  4/72 (5.56%)  3/65 (4.62%)  0/12 (0.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
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 be withheld 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: NCT02422186     History of Changes
Other Study ID Numbers: CR107129
ESKETINTRD3005 ( Other Identifier: Janssen Research & Development, LLC )
2014-004588-19 ( EudraCT Number )
First Submitted: April 16, 2015
First Posted: April 21, 2015
Results First Submitted: April 1, 2019
Results First Posted: April 24, 2019
Last Update Posted: April 24, 2019