Trial Outcomes & Findings for A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment (NCT NCT04829318)
NCT ID: NCT04829318
Last Updated: 2025-09-18
Results Overview
Percentage of participants with TEAEs were reported. An AE was 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 intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
183 participants
Primary outcome timeframe
From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Results posted on
2025-09-18
Participant Flow
A total of 183 participants who completed the maintenance phase (Week 32) of study 54135419TRD3013 (NCT04338321) were enrolled and treated in this study.
Participant milestones
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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|---|---|
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Overall Study
STARTED
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183
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Overall Study
Treated With Esketamine 28 mg
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2
|
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Overall Study
Treated With Esketamine 56 mg
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68
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Overall Study
Treated With Esketamine 84 mg
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113
|
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Overall Study
Treated With Oral AD
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182
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Overall Study
COMPLETED
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148
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Overall Study
NOT COMPLETED
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35
|
Reasons for withdrawal
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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|---|---|
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Overall Study
Adverse Event
|
6
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Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
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Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
19
|
|
Overall Study
Site terminated by sponsor
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1
|
|
Overall Study
Sponsor decision
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5
|
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Overall Study
Other
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1
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Baseline Characteristics
Participants analyzed included participants who reported ethnicity.
Baseline characteristics by cohort
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=183 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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Age, Continuous
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44.6 years
STANDARD_DEVIATION 13.07 • n=183 Participants
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Age, Customized
18-64 years
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174 Participants
n=183 Participants
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Age, Customized
>=65 years
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9 Participants
n=183 Participants
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Sex: Female, Male
Female
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128 Participants
n=183 Participants
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Sex: Female, Male
Male
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55 Participants
n=183 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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12 Participants
n=72 Participants • Participants analyzed included participants who reported ethnicity.
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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60 Participants
n=72 Participants • Participants analyzed included participants who reported ethnicity.
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=72 Participants • Participants analyzed included participants who reported ethnicity.
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=72 Participants • Participants analyzed included participants who reported race.
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Race (NIH/OMB)
Asian
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6 Participants
n=72 Participants • Participants analyzed included participants who reported race.
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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66 Participants
n=72 Participants • Participants analyzed included participants who reported race.
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Race (NIH/OMB)
Black or African American
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0 Participants
n=72 Participants • Participants analyzed included participants who reported race.
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Race (NIH/OMB)
White
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0 Participants
n=72 Participants • Participants analyzed included participants who reported race.
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Race (NIH/OMB)
More than one race
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0 Participants
n=72 Participants • Participants analyzed included participants who reported race.
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=72 Participants • Participants analyzed included participants who reported race.
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Body mass index
Underweight <18.5 kg/m^2
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5 Participants
n=155 Participants • Participants analyzed included participants who reported body mass index in kilograms per meter square (kg/m\^2).
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Body mass index
Normal 18.5 to <25 kg/m^2
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63 Participants
n=155 Participants • Participants analyzed included participants who reported body mass index in kilograms per meter square (kg/m\^2).
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Body mass index
Overweight 25 to <30 kg/m^2
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46 Participants
n=155 Participants • Participants analyzed included participants who reported body mass index in kilograms per meter square (kg/m\^2).
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Body mass index
Obese >=30 kg/m^2
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41 Participants
n=155 Participants • Participants analyzed included participants who reported body mass index in kilograms per meter square (kg/m\^2).
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PRIMARY outcome
Timeframe: From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)Population: Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
Percentage of participants with TEAEs were reported. An AE was 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 intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=183 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
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88.0 percentage of participants
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PRIMARY outcome
Timeframe: From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)Population: Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
Incidence rate of TEAEs were reported. AE Incidence rate was defined as incidence rate per 100 patient-months = (number of participants with AE divided by sum of days at risk for AE) \* 100\*365.25/12. An AE was 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 intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=183 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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Incidence Rate of Treatment-emergent Adverse Events (TEAEs)
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17.33 AEs per 100 patient-months
Interval 14.85 to 20.23
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PRIMARY outcome
Timeframe: From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)Population: Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
Percentage of participants with TESAEs were reported. An AE was 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 intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=183 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
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6.0 percentage of participants
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PRIMARY outcome
Timeframe: From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)Population: Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
Incidence rate of with TESAEs were reported. AE Incidence rate was defined as incidence rate per 100 patient-months = (number of participants with AE divided by sum of days at risk for AE) \* 100\*365.25/12. An AE was 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 intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=183 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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Incidence Rate of Treatment-emergent Serious Adverse Events (TESAEs)
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0.28 AEs per 100 patient-months
Interval 0.16 to 0.51
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PRIMARY outcome
Timeframe: From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)Population: Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
Percentage of participants with TEAEs leading to death were reported. An AE was 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 intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=183 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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Percentage of of Participants With TEAEs Leading to Death
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0.6 percentage of participants
Interval 0.16 to 0.51
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PRIMARY outcome
Timeframe: From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)Population: Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
Incidence rate of TEAEs leading to death were reported. AE Incidence rate was defined as incidence rate per 100 patient-months = (number of participants with AE divided by sum of days at risk for AE) \* 100\*365.25/12. An AE was 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 intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=183 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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|---|---|
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Incidence Rate of TEAEs Leading to Death
|
0.03 AEs per 100 patient-months
Interval 0.0 to 0.18
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PRIMARY outcome
Timeframe: From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)Population: Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
Percentage of participants with TEAEs of special interest were reported. An AE was 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 intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious AEs. AEs of special interest were separately grouped by categories sedation, dissociation, suicidality, suggestive of abuse potential, cystitis and hepatic impairment.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=183 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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|---|---|
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Percentage of Participants With Treatment-emergent AEs of Special Interest (AESIs)
Sedation
|
16.9 percentage of participants
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Percentage of Participants With Treatment-emergent AEs of Special Interest (AESIs)
Dissociation
|
12.0 percentage of participants
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Percentage of Participants With Treatment-emergent AEs of Special Interest (AESIs)
Suicidality
|
3.8 percentage of participants
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Percentage of Participants With Treatment-emergent AEs of Special Interest (AESIs)
Suggestive of abuse potential
|
37.7 percentage of participants
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Percentage of Participants With Treatment-emergent AEs of Special Interest (AESIs)
Cystitis
|
0.5 percentage of participants
|
PRIMARY outcome
Timeframe: From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)Population: Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
AE Incidence rate: incidence rate per 100 patient-months=(number of participants with AE divided by sum of days at risk for AE)\* 100\*365.25/12. An AE was 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 intervention. SAE: AE resulting in any following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial intervention administration up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious AEs. AEs of special interest were grouped as categories sedation, dissociation, suicidality, suggestive of abuse potential, cystitis and hepatic impairment.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=183 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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|---|---|
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Incidence Rate of Treatment-emergent AEs of Special Interest (AESIs)
Sedation
|
0.91 AEs per 100 patient-months
|
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Incidence Rate of Treatment-emergent AEs of Special Interest (AESIs)
Dissociation
|
0.61 AEs per 100 patient-months
|
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Incidence Rate of Treatment-emergent AEs of Special Interest (AESIs)
Suicidality
|
0.18 AEs per 100 patient-months
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Incidence Rate of Treatment-emergent AEs of Special Interest (AESIs)
Suggestive of abuse potential
|
2.63 AEs per 100 patient-months
|
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Incidence Rate of Treatment-emergent AEs of Special Interest (AESIs)
Cystitis
|
0.03 AEs per 100 patient-months
|
PRIMARY outcome
Timeframe: Baseline (Day 1 of Study 54135419TRD3013) up to Week 104 of study 54135419TRD4010 (up to Week 136)Population: Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
Number of participants with suicidal ideation and behavior in study 54135419TRD4010 as assessed by C-SSRS score were reported. C-SSRS score: an assessment tool that evaluated suicidal ideation and behavior. Suicidal ideation (5 items): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior (5 items): preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide. Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior (0), Suicidal ideation (1 to 5), Suicidal behavior (6 to 10). Total score ranged from 0 to 10. Higher scores indicated more severe suicidal ideation and behavior.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=183 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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|---|---|
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Number of Participants With Suicidal Ideation and Behavior in Study 54135419TRD4010 as Assessed by Columbia-suicide Severity Rating Scale (C-SSRS) Score
No suicidal ideation or behavior
|
158 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior in Study 54135419TRD4010 as Assessed by Columbia-suicide Severity Rating Scale (C-SSRS) Score
Suicidal ideation
|
24 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior in Study 54135419TRD4010 as Assessed by Columbia-suicide Severity Rating Scale (C-SSRS) Score
Suicidal behavior
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 of Study 54135419TRD3013) up to Week 104 of study 54135419TRD4010 (up to Week 136)Population: Analysis population included participants in remission (MADRS total score of \<=10) at any time point during Study 54135419TRD3013.
Relapse was defined by any of the following: a) Worsening of depressive symptoms as indicated by Montgomery-Asberg Depression Rating Scale (MADRS) total score \>=22 confirmed by 1 additional assessment of MADRS total score \>=22 within the next 5 to 31 days. b) Any psychiatric hospitalization for: 1) worsening of depression, 2) suicide prevention or due to a suicide attempt for any of these events. c) Suicide attempt, completed suicide, or any other clinically relevant event determined per investigator's clinical judgment to be indicative of relapse of depressive illness, but for which participant was not hospitalized. MADRS scale consisted of 10 items, scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 to 60. Higher scores represented a more severe condition.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=149 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
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|---|---|
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Percentage of Participants With No Relapse and Without Discontinuation Until the End of the Prospective Observation Period at Week 104
|
79.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010Population: Efficacy analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points.
Change from baseline of study 54135419TRD3013 in Clinician-rated MADRS total score were reported. MADRS was a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items , scored from 0 (item is not present or normal) to 6 (severe or continuous presence of symptoms), summed up for a total possible score range of 0 to 60. Higher scores represented a more severe condition. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=181 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
|
|---|---|
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Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 44
|
-22.9 score on a scale
Standard Deviation 7.41
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 48
|
-22.9 score on a scale
Standard Deviation 7.19
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 52
|
-22.6 score on a scale
Standard Deviation 7.13
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 60
|
-23.1 score on a scale
Standard Deviation 7.11
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 68
|
-23.2 score on a scale
Standard Deviation 7.10
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 72
|
-23.6 score on a scale
Standard Deviation 6.98
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 64
|
-23.4 score on a scale
Standard Deviation 7.52
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 76
|
-23.8 score on a scale
Standard Deviation 6.91
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 80
|
-23.7 score on a scale
Standard Deviation 7.19
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 84
|
-23.6 score on a scale
Standard Deviation 6.87
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 88
|
-24.4 score on a scale
Standard Deviation 6.78
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 92
|
-24.3 score on a scale
Standard Deviation 7.17
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 96
|
-24.7 score on a scale
Standard Deviation 6.57
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 100
|
-24.9 score on a scale
Standard Deviation 6.39
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 104
|
-25.3 score on a scale
Standard Deviation 6.69
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 28
|
-22.4 score on a scale
Standard Deviation 7.13
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 32
|
-22.5 score on a scale
Standard Deviation 7.16
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 36
|
-22.5 score on a scale
Standard Deviation 8.12
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 40
|
-22.7 score on a scale
Standard Deviation 7.03
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 56
|
-23.0 score on a scale
Standard Deviation 6.88
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 4
|
-21.9 score on a scale
Standard Deviation 8.10
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 8
|
-21.8 score on a scale
Standard Deviation 7.93
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 12
|
-22.5 score on a scale
Standard Deviation 7.25
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 16
|
-22.8 score on a scale
Standard Deviation 7.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 20
|
-22.3 score on a scale
Standard Deviation 7.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 24
|
-22.6 score on a scale
Standard Deviation 6.82
|
SECONDARY outcome
Timeframe: Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010Population: Efficacy analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points.
Change from Baseline of Study 54135419TRD3013 in Clinician-rated MADRS Score Individual Items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts) were reported. MADRS was a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed up for a total possible score range of 0 to 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=181 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
|
|---|---|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 8: Apparent Sadness
|
-3.0 score on a scale
Standard Deviation 1.45
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 44: Apparent Sadness
|
-3.1 score on a scale
Standard Deviation 1.38
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 52: Apparent Sadness
|
-3.1 score on a scale
Standard Deviation 1.32
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 56: Apparent Sadness
|
-3.1 score on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 60: Apparent Sadness
|
-3.1 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 68: Apparent Sadness
|
-3.1 score on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 76: Apparent Sadness
|
-3.3 score on a scale
Standard Deviation 1.22
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 80: Apparent Sadness
|
-3.3 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 84: Apparent Sadness
|
-3.2 score on a scale
Standard Deviation 1.15
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 88: Apparent Sadness
|
-3.4 score on a scale
Standard Deviation 1.17
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 100: Apparent Sadness
|
-3.4 score on a scale
Standard Deviation 1.13
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 104: Apparent Sadness
|
-3.5 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 8: Reported Sadness
|
-3.0 score on a scale
Standard Deviation 1.38
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 12: Reported Sadness
|
-3.0 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 16: Reported Sadness
|
-3.1 score on a scale
Standard Deviation 1.28
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 20: Reported Sadness
|
-3.1 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 24: Reported Sadness
|
-3.1 score on a scale
Standard Deviation 1.19
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 56: Reported Sadness
|
-3.2 score on a scale
Standard Deviation 1.12
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 60: Reported Sadness
|
-3.3 score on a scale
Standard Deviation 1.14
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 64: Reported Sadness
|
-3.3 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 68: Reported Sadness
|
-3.2 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 72: Reported Sadness
|
-3.2 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 80: Reported Sadness
|
-3.3 score on a scale
Standard Deviation 1.12
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 84: Reported Sadness
|
-3.3 score on a scale
Standard Deviation 1.10
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 88: Reported Sadness
|
-3.3 score on a scale
Standard Deviation 1.14
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 96: Reported Sadness
|
-3.4 score on a scale
Standard Deviation 1.03
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 4: Reduced Sleep
|
-2.1 score on a scale
Standard Deviation 1.72
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 8: Reduced Sleep
|
-2.2 score on a scale
Standard Deviation 1.64
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 24: Reduced Sleep
|
-2.2 score on a scale
Standard Deviation 1.68
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 72: Reduced Sleep
|
-2.3 score on a scale
Standard Deviation 1.66
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 72: Concentration Difficulties
|
-2.4 score on a scale
Standard Deviation 1.10
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 76: Concentration Difficulties
|
-2.5 score on a scale
Standard Deviation 1.17
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 4: Lassitude
|
-2.5 score on a scale
Standard Deviation 1.36
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 52: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.15
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 56: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.16
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 88: Lassitude
|
-2.8 score on a scale
Standard Deviation 1.14
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 8: Inability to Feel
|
-2.6 score on a scale
Standard Deviation 1.34
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 16: Inability to Feel
|
-2.8 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 20: Inability to Feel
|
-2.6 score on a scale
Standard Deviation 1.19
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 40: Inability to Feel
|
-2.8 score on a scale
Standard Deviation 1.22
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 48: Inability to Feel
|
-2.7 score on a scale
Standard Deviation 1.27
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 56: Inability to Feel
|
-2.8 score on a scale
Standard Deviation 1.22
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 84: Inability to Feel
|
-2.9 score on a scale
Standard Deviation 1.34
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 28: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 44: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 60: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.27
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 96: Pessimistic Thoughts
|
-2.2 score on a scale
Standard Deviation 1.16
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 68: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 0.98
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 80: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.03
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 92: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 0.97
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 96: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.04
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 4: Apparent Sadness
|
-3.0 score on a scale
Standard Deviation 1.38
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 12: Apparent Sadness
|
-3.0 score on a scale
Standard Deviation 1.34
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 16: Apparent Sadness
|
-3.1 score on a scale
Standard Deviation 1.34
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 20: Apparent Sadness
|
-3.1 score on a scale
Standard Deviation 1.31
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 24: Apparent Sadness
|
-2.9 score on a scale
Standard Deviation 1.36
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 28: Apparent Sadness
|
-3.0 score on a scale
Standard Deviation 1.33
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 32: Reported Sadness
|
-3.1 score on a scale
Standard Deviation 1.18
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 32: Apparent Sadness
|
-3.0 score on a scale
Standard Deviation 1.28
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 36: Apparent Sadness
|
-3.0 score on a scale
Standard Deviation 1.42
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 40: Apparent Sadness
|
-3.0 score on a scale
Standard Deviation 1.36
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 48: Apparent Sadness
|
-3.1 score on a scale
Standard Deviation 1.34
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 64: Apparent Sadness
|
-3.2 score on a scale
Standard Deviation 1.33
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 44: Reported Sadness
|
-3.1 score on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 72: Apparent Sadness
|
-3.2 score on a scale
Standard Deviation 1.21
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 92: Apparent Sadness
|
-3.3 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 96: Apparent Sadness
|
-3.3 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 4: Reported Sadness
|
-3.1 score on a scale
Standard Deviation 1.29
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 28: Reported Sadness
|
-3.0 score on a scale
Standard Deviation 1.21
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 36: Reported Sadness
|
-3.0 score on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 40: Reported Sadness
|
-3.2 score on a scale
Standard Deviation 1.18
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 48: Reported Sadness
|
-3.1 score on a scale
Standard Deviation 1.22
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 52: Reported Sadness
|
-3.1 score on a scale
Standard Deviation 1.19
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 76: Reported Sadness
|
-3.3 score on a scale
Standard Deviation 1.16
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 92: Reported Sadness
|
-3.3 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 100: Reported Sadness
|
-3.4 score on a scale
Standard Deviation 1.05
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 104: Reported Sadness
|
-3.5 score on a scale
Standard Deviation 1.07
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 4: Inner Tension
|
-1.8 score on a scale
Standard Deviation 1.19
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 8: Inner Tension
|
-1.8 score on a scale
Standard Deviation 1.18
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 12: Inner Tension
|
-1.9 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 16: Inner Tension
|
-1.9 score on a scale
Standard Deviation 1.15
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 20: Inner Tension
|
-1.8 score on a scale
Standard Deviation 1.19
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 24: Inner Tension
|
-1.9 score on a scale
Standard Deviation 1.21
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 28: Inner Tension
|
-1.8 score on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 68: Inner Tension
|
-1.9 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 72: Inner Tension
|
-2.0 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 76: Inner Tension
|
-2.0 score on a scale
Standard Deviation 1.22
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 80: Inner Tension
|
-2.1 score on a scale
Standard Deviation 1.13
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 84: Inner Tension
|
-2.0 score on a scale
Standard Deviation 1.28
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 88: Inner Tension
|
-2.0 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 92: Inner Tension
|
-2.0 score on a scale
Standard Deviation 1.16
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 96: Inner Tension
|
-2.0 score on a scale
Standard Deviation 1.14
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 100: Inner Tension
|
-2.0 score on a scale
Standard Deviation 1.18
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 104: Inner Tension
|
-2.1 score on a scale
Standard Deviation 1.22
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 32: Inner Tension
|
-1.9 score on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 36: Inner Tension
|
-2.0 score on a scale
Standard Deviation 1.07
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 40: Inner Tension
|
-1.8 score on a scale
Standard Deviation 1.17
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 44: Inner Tension
|
-1.9 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 48: Inner Tension
|
-2.0 score on a scale
Standard Deviation 1.25
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 52: Inner Tension
|
-1.9 score on a scale
Standard Deviation 1.16
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 56: Inner Tension
|
-2.0 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 60: Inner Tension
|
-1.9 score on a scale
Standard Deviation 1.32
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 64: Inner Tension
|
-2.0 score on a scale
Standard Deviation 1.34
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 88: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 0.98
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 64: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 68: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.21
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 72: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.17
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 76: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.16
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 80: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 84: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 88: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.18
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 92: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.21
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 100: Pessimistic Thoughts
|
-2.2 score on a scale
Standard Deviation 1.22
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 104: Pessimistic Thoughts
|
-2.2 score on a scale
Standard Deviation 1.18
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 4: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.05
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 8: Suicidal Thoughts
|
-0.7 score on a scale
Standard Deviation 0.97
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 12: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.05
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 16: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.04
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 20: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.01
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 24: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.06
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 28: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.02
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 32: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.01
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 36: Suicidal Thoughts
|
-0.7 score on a scale
Standard Deviation 1.13
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 40: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 0.97
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 44: Suicidal Thoughts
|
-0.7 score on a scale
Standard Deviation 0.91
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 48: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 0.98
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 52: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 0.98
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 56: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 0.99
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 60: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 0.97
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 64: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 0.98
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 72: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.01
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 76: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.01
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 84: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 0.97
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 100: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.03
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 104: Suicidal Thoughts
|
-0.8 score on a scale
Standard Deviation 1.01
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 56: Reduced Sleep
|
-2.2 score on a scale
Standard Deviation 1.73
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 60: Reduced Sleep
|
-2.3 score on a scale
Standard Deviation 1.62
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 12: Reduced Sleep
|
-2.2 score on a scale
Standard Deviation 1.63
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 16: Reduced Sleep
|
-2.2 score on a scale
Standard Deviation 1.75
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 20: Reduced Sleep
|
-2.3 score on a scale
Standard Deviation 1.72
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 28: Reduced Sleep
|
-2.2 score on a scale
Standard Deviation 1.72
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 32: Reduced Sleep
|
-2.3 score on a scale
Standard Deviation 1.70
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 36: Reduced Sleep
|
-2.3 score on a scale
Standard Deviation 1.81
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 40: Reduced Sleep
|
-2.3 score on a scale
Standard Deviation 1.76
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 44: Reduced Sleep
|
-2.4 score on a scale
Standard Deviation 1.61
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 48: Reduced Sleep
|
-2.3 score on a scale
Standard Deviation 1.69
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 52: Reduced Sleep
|
-2.2 score on a scale
Standard Deviation 1.64
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 64: Reduced Sleep
|
-2.2 score on a scale
Standard Deviation 1.70
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 68: Reduced Sleep
|
-2.4 score on a scale
Standard Deviation 1.82
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 76: Reduced Sleep
|
-2.4 score on a scale
Standard Deviation 1.67
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 80: Reduced Sleep
|
-2.3 score on a scale
Standard Deviation 1.84
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 84: Reduced Sleep
|
-2.4 score on a scale
Standard Deviation 1.73
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 88: Reduced Sleep
|
-2.5 score on a scale
Standard Deviation 1.58
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 92: Reduced Sleep
|
-2.4 score on a scale
Standard Deviation 1.70
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 96: Reduced Sleep
|
-2.5 score on a scale
Standard Deviation 1.66
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 100: Reduced Sleep
|
-2.5 score on a scale
Standard Deviation 1.66
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 104: Reduced Sleep
|
-2.6 score on a scale
Standard Deviation 1.76
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 4: Reduced Appetite
|
-1.7 score on a scale
Standard Deviation 1.78
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 8: Reduced Appetite
|
-1.7 score on a scale
Standard Deviation 1.75
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 12: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.68
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 16: Reduced Appetite
|
-2.0 score on a scale
Standard Deviation 1.69
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 20: Reduced Appetite
|
-1.8 score on a scale
Standard Deviation 1.74
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 24: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.74
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 28: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.74
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 32: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.72
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 36: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.81
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 40: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.69
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 44: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.81
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 48: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.73
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 52: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.78
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 56: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.65
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 60: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.68
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 64: Reduced Appetite
|
-2.0 score on a scale
Standard Deviation 1.67
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 68: Reduced Appetite
|
-2.0 score on a scale
Standard Deviation 1.69
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 72: Reduced Appetite
|
-2.0 score on a scale
Standard Deviation 1.64
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 76: Reduced Appetite
|
-2.0 score on a scale
Standard Deviation 1.62
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 80: Reduced Appetite
|
-1.9 score on a scale
Standard Deviation 1.78
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 84: Reduced Appetite
|
-2.0 score on a scale
Standard Deviation 1.70
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 88: Reduced Appetite
|
-2.0 score on a scale
Standard Deviation 1.73
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 92: Reduced Appetite
|
-2.0 score on a scale
Standard Deviation 1.67
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 96: Reduced Appetite
|
-2.1 score on a scale
Standard Deviation 1.61
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 100: Reduced Appetite
|
-2.0 score on a scale
Standard Deviation 1.69
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 104: Reduced Appetite
|
-2.1 score on a scale
Standard Deviation 1.72
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 4: Concentration Difficulties
|
-2.2 score on a scale
Standard Deviation 1.28
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 8: Concentration Difficulties
|
-2.3 score on a scale
Standard Deviation 1.37
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 12: Concentration Difficulties
|
-2.3 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 16: Concentration Difficulties
|
-2.3 score on a scale
Standard Deviation 1.28
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 20: Concentration Difficulties
|
-2.2 score on a scale
Standard Deviation 1.25
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 24: Concentration Difficulties
|
-2.3 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 28: Concentration Difficulties
|
-2.2 score on a scale
Standard Deviation 1.28
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 32: Concentration Difficulties
|
-2.2 score on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 36: Concentration Difficulties
|
-2.3 score on a scale
Standard Deviation 1.28
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 40: Concentration Difficulties
|
-2.3 score on a scale
Standard Deviation 1.21
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 44: Concentration Difficulties
|
-2.3 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 48: Concentration Difficulties
|
-2.4 score on a scale
Standard Deviation 1.18
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 52: Concentration Difficulties
|
-2.4 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 56: Concentration Difficulties
|
-2.4 score on a scale
Standard Deviation 1.14
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 60: Concentration Difficulties
|
-2.3 score on a scale
Standard Deviation 1.19
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 64: Concentration Difficulties
|
-2.4 score on a scale
Standard Deviation 1.25
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 68: Concentration Difficulties
|
-2.4 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 80: Concentration Difficulties
|
-2.4 score on a scale
Standard Deviation 1.10
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 84: Concentration Difficulties
|
-2.4 score on a scale
Standard Deviation 1.14
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 88: Concentration Difficulties
|
-2.6 score on a scale
Standard Deviation 1.08
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 92: Concentration Difficulties
|
-2.6 score on a scale
Standard Deviation 1.12
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 96: Concentration Difficulties
|
-2.5 score on a scale
Standard Deviation 1.10
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 100: Concentration Difficulties
|
-2.6 score on a scale
Standard Deviation 1.06
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 104: Concentration Difficulties
|
-2.6 score on a scale
Standard Deviation 1.10
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 8: Lassitude
|
-2.4 score on a scale
Standard Deviation 1.33
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 12: Lassitude
|
-2.5 score on a scale
Standard Deviation 1.22
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 16: Lassitude
|
-2.5 score on a scale
Standard Deviation 1.27
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 20: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.33
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 24: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.21
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 28: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.21
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 32: Lassitude
|
-2.5 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 36: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.30
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 40: Lassitude
|
-2.5 score on a scale
Standard Deviation 1.17
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 44: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.16
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 48: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.19
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 60: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.25
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 64: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.25
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 68: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.21
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 72: Lassitude
|
-2.7 score on a scale
Standard Deviation 1.13
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 76: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.11
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 80: Lassitude
|
-2.8 score on a scale
Standard Deviation 1.00
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 84: Lassitude
|
-2.6 score on a scale
Standard Deviation 1.09
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 92: Lassitude
|
-2.7 score on a scale
Standard Deviation 1.09
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 96: Lassitude
|
-2.8 score on a scale
Standard Deviation 1.11
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 100: Lassitude
|
-2.9 score on a scale
Standard Deviation 1.00
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 104: Lassitude
|
-2.9 score on a scale
Standard Deviation 0.91
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 4: Inability to Feel
|
-2.7 score on a scale
Standard Deviation 1.29
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 12: Inability to Feel
|
-2.7 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 24: Inability to Feel
|
-2.8 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 28: Inability to Feel
|
-2.7 score on a scale
Standard Deviation 1.27
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 32: Inability to Feel
|
-2.8 score on a scale
Standard Deviation 1.30
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 36: Inability to Feel
|
-2.8 score on a scale
Standard Deviation 1.28
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 44: Inability to Feel
|
-2.8 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 52: Inability to Feel
|
-2.7 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 60: Inability to Feel
|
-2.9 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 64: Inability to Feel
|
-2.9 score on a scale
Standard Deviation 1.21
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 68: Inability to Feel
|
-2.8 score on a scale
Standard Deviation 1.14
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 72: Inability to Feel
|
-2.8 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 76: Inability to Feel
|
-2.8 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 80: Inability to Feel
|
-2.9 score on a scale
Standard Deviation 1.29
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 88: Inability to Feel
|
-2.9 score on a scale
Standard Deviation 1.13
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 92: Inability to Feel
|
-3.0 score on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 96: Inability to Feel
|
-3.0 score on a scale
Standard Deviation 1.13
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 100: Inability to Feel
|
-3.0 score on a scale
Standard Deviation 1.15
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 104: Inability to Feel
|
-3.0 score on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 4: Pessimistic Thoughts
|
-2.0 score on a scale
Standard Deviation 1.25
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 8: Pessimistic Thoughts
|
-2.0 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 12: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 16: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 20: Pessimistic Thoughts
|
-2.0 score on a scale
Standard Deviation 1.25
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 24: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 32: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 36: Pessimistic Thoughts
|
-2.0 score on a scale
Standard Deviation 1.33
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 40: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.27
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 48: Pessimistic Thoughts
|
-2.1 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 52: Pessimistic Thoughts
|
-2.0 score on a scale
Standard Deviation 1.22
|
|
Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items
Week 56: Pessimistic Thoughts
|
-2.0 score on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010Population: Efficacy analysis set included all subjects who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points.
Change from Baseline of Study 54135419TRD3013 in CGI-S scale score were reported. The CGI-S provided an overall clinician-determined summary measure of the severity of the participant's illness that took into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluated the severity of psychopathology on a scale of 1 to 7: where, 1 = normal (not ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participant's. Negative change in score indicated improvement. Participant's with a score of zero were considered missing.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=181 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
|
|---|---|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 24
|
-2.7 score on a scale
Standard Deviation 0.96
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 92
|
-3.0 score on a scale
Standard Deviation 0.88
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 100
|
-3.1 score on a scale
Standard Deviation 0.87
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 4
|
-2.5 score on a scale
Standard Deviation 1.00
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 8
|
-2.6 score on a scale
Standard Deviation 1.02
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 12
|
-2.6 score on a scale
Standard Deviation 0.99
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 16
|
-2.6 score on a scale
Standard Deviation 0.96
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 20
|
-2.6 score on a scale
Standard Deviation 0.96
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 28
|
-2.8 score on a scale
Standard Deviation 0.96
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 32
|
-2.7 score on a scale
Standard Deviation 1.01
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 36
|
-2.7 score on a scale
Standard Deviation 0.99
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 40
|
-2.9 score on a scale
Standard Deviation 0.99
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 44
|
-2.9 score on a scale
Standard Deviation 0.98
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 48
|
-2.9 score on a scale
Standard Deviation 0.96
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 52
|
-2.8 score on a scale
Standard Deviation 1.00
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 56
|
-2.9 score on a scale
Standard Deviation 0.93
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 60
|
-2.9 score on a scale
Standard Deviation 0.96
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 64
|
-2.9 score on a scale
Standard Deviation 0.99
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 68
|
-2.9 score on a scale
Standard Deviation 0.93
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 72
|
-2.9 score on a scale
Standard Deviation 0.93
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 76
|
-2.9 score on a scale
Standard Deviation 0.93
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 80
|
-2.9 score on a scale
Standard Deviation 0.91
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 84
|
-3.0 score on a scale
Standard Deviation 0.86
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 88
|
-3.0 score on a scale
Standard Deviation 0.88
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 96
|
-3.1 score on a scale
Standard Deviation 0.88
|
|
Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score
Week 104
|
-3.1 score on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010Population: Efficacy analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points.
Change from Baseline of Study 54135419TRD3013 in PHQ 9-item total score were reported. The PHQ-9 was a validated 9-item, patient-reported outcome (PRO) measure to assess depressive symptoms. Each item was rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses were summed to a total score with a range of 0 to 27. Higher scores indicated greater severity of depressive symptoms.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=178 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
|
|---|---|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 20
|
-11.3 score on a scale
Standard Deviation 5.46
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 28
|
-11.5 score on a scale
Standard Deviation 5.25
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 32
|
-11.3 score on a scale
Standard Deviation 5.71
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 104
|
-12.7 score on a scale
Standard Deviation 4.97
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 4
|
-11.0 score on a scale
Standard Deviation 5.80
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 8
|
-10.9 score on a scale
Standard Deviation 5.98
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 12
|
-10.9 score on a scale
Standard Deviation 5.73
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 16
|
-11.2 score on a scale
Standard Deviation 5.53
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 24
|
-11.3 score on a scale
Standard Deviation 5.19
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 36
|
-11.6 score on a scale
Standard Deviation 6.06
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 40
|
-11.5 score on a scale
Standard Deviation 5.55
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 44
|
-11.9 score on a scale
Standard Deviation 5.67
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 48
|
-11.9 score on a scale
Standard Deviation 5.61
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 52
|
-11.4 score on a scale
Standard Deviation 5.55
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 56
|
-12.0 score on a scale
Standard Deviation 5.19
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 60
|
-11.9 score on a scale
Standard Deviation 5.24
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 64
|
-11.9 score on a scale
Standard Deviation 5.18
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 68
|
-11.9 score on a scale
Standard Deviation 5.60
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 72
|
-12.1 score on a scale
Standard Deviation 5.00
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 76
|
-12.2 score on a scale
Standard Deviation 5.12
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 80
|
-12.1 score on a scale
Standard Deviation 5.28
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 84
|
-11.9 score on a scale
Standard Deviation 5.19
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 88
|
-12.2 score on a scale
Standard Deviation 5.21
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 92
|
-12.5 score on a scale
Standard Deviation 5.11
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 96
|
-12.2 score on a scale
Standard Deviation 5.10
|
|
Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score
Week 100
|
-12.7 score on a scale
Standard Deviation 4.78
|
SECONDARY outcome
Timeframe: Baseline (Day 1 of Study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010Population: Efficacy analysis set included all subjects who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points.
Change from baseline of Study 54135419TRD3013 in EQ-5D-5LQuestionnaire Score: health status index were reported. The EQ-5D-5L descriptive system comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions were 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). The participant selected an answer for each of the 5 dimensions considering a response that best matched participant's health "today." Responses were used to generate health status index ranged from -0.594 to 1 (where 1 represents full health and negative values represent health states considered worse than dead). Positive change in score indicated improvement.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=178 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
|
|---|---|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 8
|
0.320 score on a scale
Standard Deviation 0.2518
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 80
|
0.362 score on a scale
Standard Deviation 0.2375
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 92
|
0.367 score on a scale
Standard Deviation 0.2275
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 4
|
0.323 score on a scale
Standard Deviation 0.2479
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 12
|
0.325 score on a scale
Standard Deviation 0.2379
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 16
|
0.322 score on a scale
Standard Deviation 0.2568
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 20
|
0.336 score on a scale
Standard Deviation 0.2444
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 24
|
0.331 score on a scale
Standard Deviation 0.2337
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 28
|
0.323 score on a scale
Standard Deviation 0.2415
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 32
|
0.335 score on a scale
Standard Deviation 0.2377
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 36
|
0.341 score on a scale
Standard Deviation 0.2512
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 40
|
0.333 score on a scale
Standard Deviation 0.2364
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 44
|
0.343 score on a scale
Standard Deviation 0.2576
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 48
|
0.345 score on a scale
Standard Deviation 0.2317
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 52
|
0.332 score on a scale
Standard Deviation 0.2374
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 56
|
0.348 score on a scale
Standard Deviation 0.2348
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 60
|
0.364 score on a scale
Standard Deviation 0.2322
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 64
|
0.350 score on a scale
Standard Deviation 0.2422
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 68
|
0.337 score on a scale
Standard Deviation 0.2546
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 72
|
0.354 score on a scale
Standard Deviation 0.2295
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 76
|
0.357 score on a scale
Standard Deviation 0.2440
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 84
|
0.350 score on a scale
Standard Deviation 0.2295
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 88
|
0.366 score on a scale
Standard Deviation 0.2385
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 96
|
0.375 score on a scale
Standard Deviation 0.2333
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 100
|
0.387 score on a scale
Standard Deviation 0.2321
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index
Week 104
|
0.387 score on a scale
Standard Deviation 0.2444
|
SECONDARY outcome
Timeframe: Baseline (Day 1 of Study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010Population: Efficacy analysis set included all subjects who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points.
Change from baseline of Study 54135419TRD3013 in EQ-5D-5L: visual analogue scale were reported. EQ-VAS self-rating recorded the participant'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). Positive change in score indicated improvement.
Outcome measures
| Measure |
Esketamine Nasal Spray + Oral Antidepressant (AD)
n=175 Participants
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
|
|---|---|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 4
|
27.35 score on a scale
Standard Deviation 20.595
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 64
|
30.49 score on a scale
Standard Deviation 20.352
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 68
|
29.82 score on a scale
Standard Deviation 20.195
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 92
|
31.87 score on a scale
Standard Deviation 20.228
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 8
|
26.24 score on a scale
Standard Deviation 21.939
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 12
|
26.74 score on a scale
Standard Deviation 20.884
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 16
|
27.98 score on a scale
Standard Deviation 20.523
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 20
|
27.85 score on a scale
Standard Deviation 20.143
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 24
|
28.83 score on a scale
Standard Deviation 20.438
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 28
|
28.23 score on a scale
Standard Deviation 21.006
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 32
|
28.30 score on a scale
Standard Deviation 21.119
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 36
|
29.99 score on a scale
Standard Deviation 19.901
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 40
|
28.56 score on a scale
Standard Deviation 21.210
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 44
|
29.19 score on a scale
Standard Deviation 21.259
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 48
|
29.57 score on a scale
Standard Deviation 21.717
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 52
|
29.60 score on a scale
Standard Deviation 21.419
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 56
|
29.90 score on a scale
Standard Deviation 20.828
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 60
|
30.47 score on a scale
Standard Deviation 20.423
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 72
|
30.84 score on a scale
Standard Deviation 20.252
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 76
|
31.90 score on a scale
Standard Deviation 19.866
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 80
|
31.23 score on a scale
Standard Deviation 20.512
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 84
|
30.40 score on a scale
Standard Deviation 19.697
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 88
|
31.10 score on a scale
Standard Deviation 20.469
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 96
|
30.75 score on a scale
Standard Deviation 19.759
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 100
|
31.66 score on a scale
Standard Deviation 18.887
|
|
Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)
Week 104
|
33.75 score on a scale
Standard Deviation 19.356
|
Adverse Events
Esketamine + Oral AD
Serious events: 11 serious events
Other events: 145 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Esketamine + Oral AD
n=183 participants at risk
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\],and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 105 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.55%
1/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Endocrine disorders
Goitre
|
0.55%
1/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Eye disorders
Macular hole
|
0.55%
1/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.55%
1/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.55%
1/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.55%
1/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.55%
1/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.55%
1/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.55%
1/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Psychiatric disorders
Depression
|
0.55%
1/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.55%
1/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
Other adverse events
| Measure |
Esketamine + Oral AD
n=183 participants at risk
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\],and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 105 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
17.5%
32/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Eye disorders
Lacrimation increased
|
5.5%
10/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.2%
15/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.2%
15/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Gastrointestinal disorders
Nausea
|
20.2%
37/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
12/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Infections and infestations
COVID-19
|
16.4%
30/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Infections and infestations
Nasopharyngitis
|
20.2%
37/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Investigations
Blood pressure increased
|
7.1%
13/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
11/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.9%
20/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Nervous system disorders
Dizziness
|
27.3%
50/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
14/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Nervous system disorders
Headache
|
44.3%
81/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Nervous system disorders
Paraesthesia
|
7.1%
13/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Nervous system disorders
Somnolence
|
13.1%
24/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Psychiatric disorders
Dissociation
|
10.4%
19/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
10/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
7.1%
13/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.1%
13/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
7.7%
14/183 • From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.
|
Additional Information
Director Global Medical Affairs Lead
Janssen-Cilag Limited
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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 to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER