{"protocolSection":{"identificationModule":{"nctId":"NCT04338321","orgStudyIdInfo":{"id":"CR108787"},"secondaryIdInfos":[{"id":"2019-002992-33","type":"EUDRACT_NUMBER"},{"id":"54135419TRD3013","type":"OTHER","domain":"Janssen-Cilag International NV"},{"id":"2019","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2019"}],"organization":{"fullName":"Janssen-Cilag International NV","class":"INDUSTRY"},"briefTitle":"A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder","officialTitle":"A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor","acronym":"ESCAPE-TRD"},"statusModule":{"statusVerifiedDate":"2025-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-08-21","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-01-20","type":"ACTUAL"},"completionDateStruct":{"date":"2022-07-15","type":"ACTUAL"},"studyFirstSubmitDate":"2020-04-06","studyFirstSubmitQcDate":"2020-04-06","studyFirstPostDateStruct":{"date":"2020-04-08","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-01-19","resultsFirstSubmitQcDate":"2023-01-19","resultsFirstPostDateStruct":{"date":"2023-02-15","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-04-25","lastUpdatePostDateStruct":{"date":"2025-04-29","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Janssen-Cilag International NV","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants who have treatment-resistant major depressive disorder (MDD) with a current moderate to severe depressive episode.","detailedDescription":"A depressive state with classical symptoms such as low (depressive/sad) mood, markedly diminished interest in activities, significant weight loss/gain, insomnia or hypersomnia, psychomotor agitation/retardation, excessive fatigue, inappropriate guilt, diminished concentration, and recurrent thoughts of death, persisting for more than 2 weeks is classified as major depressive disorder (MDD). The mechanism of action of ketamine is distinct from conventional antidepressants (ADs), which target the monoamines (serotonin, norepinephrine, and/or dopamine). Esketamine, the S-enantiomer of ketamine, is approved and widely used for the induction and maintenance of anesthesia via intramuscular or intravenous (IV) administration. There is a significant unmet need to develop novel AD treatments based on the relevant psychophysiological pathways underlying MDD. The goal of any novel treatment would be the rapid and long-lasting relief of depressive symptoms, especially in participants with treatment-resistant depression (TRD), who lack a sufficient response to the currently available treatment strategies. The study consists of a Screening Phase (up to 14 days), an Acute Phase (8 Weeks), a Maintenance Phase (24 Weeks) and a Safety Follow-up Phase (2 Weeks). Safety assessment includes adverse event, serious adverse events, physical examination, vital signs, electrocardiogram, clinical safety laboratory assessments, suicidal risk monitoring. The total duration of the study is approximately 36 Weeks for all participants."},"conditionsModule":{"conditions":["Depressive Disorder, Major"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":676,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Esketamine Arm","type":"EXPERIMENTAL","description":"Participants will receive treatment with esketamine nasal spray (28 milligram \\[mg\\] \\[initial dose for elderly participants 65 to 74 years of age and adults of Japanese ancestry; may be used throughout the study in these populations; may be uptitrated in 28 mg increments\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years and may be used for all age groups throughout the study\\], or 84 mg \\[maximum dose esketamine nasal spray may be uptitrated to\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI).","interventionNames":["Drug: Esketamine 28 mg","Drug: Esketamine 56 mg","Drug: Esketamine 84 mg","Drug: SSRI/SNRI"]},{"label":"Comparator Arm","type":"ACTIVE_COMPARATOR","description":"Participants will continue to take their current SSRI/SNRI augmented with quetiapine extended release (XR) as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable). In adult participants aged 18 to 64 years, the initial dose is 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 \\[lowest effective dose\\]; a further dose increase to 300 mg/day on Day 5 and onward will be based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose is 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day will be based on individual participant evaluation no earlier than Day 22.","interventionNames":["Drug: Quetiapine XR 50 mg","Drug: Quetiapine XR 100 mg","Drug: Quetiapine XR 150 mg","Drug: SSRI/SNRI"]}],"interventions":[{"type":"DRUG","name":"Esketamine 28 mg","description":"Esketamine will be self-administered at a dose of 28 mg as nasal spray.","armGroupLabels":["Esketamine Arm"]},{"type":"DRUG","name":"Esketamine 56 mg","description":"Esketamine will be self-administered at a dose of 56 mg as nasal spray.","armGroupLabels":["Esketamine Arm"]},{"type":"DRUG","name":"Esketamine 84 mg","description":"Esketamine will be self-administered at a dose of 84 mg (maximum uptitrated dose) as nasal spray.","armGroupLabels":["Esketamine Arm"]},{"type":"DRUG","name":"Quetiapine XR 50 mg","description":"Quetiapine XR will be administered at an initial dose of 50 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.","armGroupLabels":["Comparator Arm"]},{"type":"DRUG","name":"Quetiapine XR 100 mg","description":"Quetiapine XR will be administered at a dose of 100 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.","armGroupLabels":["Comparator Arm"]},{"type":"DRUG","name":"Quetiapine XR 150 mg","description":"Quetiapine XR will be administered at a dose of 150 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.","armGroupLabels":["Comparator Arm"]},{"type":"DRUG","name":"SSRI/SNRI","description":"Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the SmPC (or local equivalent, if applicable).","armGroupLabels":["Comparator Arm","Esketamine Arm"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Participants With Remission as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Score at Week 8","description":"Percentage of participants with remission as assessed by the MADRS at Week 8 was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is 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 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. A participant was defined as being in remission if the MADRS total score was less than or equal to (\\<=)10 and no treatment or study discontinuation before Week 8.","timeFrame":"Week 8"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With Both Remission at Week 8 and Relapse-free Until Week 32","description":"Percentage of participants with both remission at Week 8 and relapse-free until Week 32 were reported. A participant was defined as being in remission if the MADRS total score was \\<= 10 and no treatment or study discontinuation before Week 8. A relapse was defined by any of following: a) Worsening of depressive symptoms as indicated by MADRS total score greater than or equal to (\\>=) 22 confirmed by 1 additional assessment of MADRS total score \\>= 22 within the next 5 to 15 days. The date of the second MADRS assessment was used for the date of relapse; b) Any psychiatric hospitalization for: worsening of depression, suicide prevention or suicide attempt, the start date of hospitalization was the date of relapse; c) Suicide attempt, completed suicide, or any other clinically relevant event determined by investigator's judgment to be indicative of a relapse of depressive illness, but without hospitalized. The onset of the event was used for the date of relapse.","timeFrame":"Week 32"},{"measure":"Change From Baseline in Clinician-rated Overall MADRS Score","description":"Change from baseline in clinician-rated overall MADRS score was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, 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. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts.","timeFrame":"Baseline, Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32"},{"measure":"Change From Baseline in Clinician-rated Overall MADRS Score at Last Observation Carried Forward (LOCF)","description":"Change from baseline in clinician-rated overall MADRS score at LOCF was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, 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. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","timeFrame":"Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32"},{"measure":"Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Severity (CGI-S) Scale Score","description":"Change from baseline in clinician-rated overall severity of depressive illness as assessed by CGI-S scale score was reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes 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 evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative change in score indicates improvement.","timeFrame":"Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-S Scale Score at LOCF","description":"Change from Baseline in clinician-rated overall severity of depressive illness as assessed by CGI-S scale score at LOCF was reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes 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 evaluates the severity of psychopathology on a scale of 1 to 7. A participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","timeFrame":"Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Change (CGI-C) Scale Score","description":"Clinician-rated overall severity of depressive illness as assessed by CGI-C scale score was reported. The CGI-C evaluates the total improvement whether or not entirely due to drug treatment on a scale of 1 to 7. Compared to the condition at baseline, a participant is assessed on how much he/she has changed, according to: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Higher scores indicate more severity.","timeFrame":"Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Number of Participants With Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-C Scale Score at LOCF","description":"Number of participants with clinician-rated overall severity of depressive illness as assessed by CGI-C scale score at LOCF was reported. The CGI-C evaluates the total improvement whether or not entirely due to drug treatment on a scale of 1 to 7. Compared to the condition at baseline, a participant is assessed on how much he/she has changed, according to: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Higher scores indicate more severity. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","timeFrame":"Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported Depressive Symptoms as Assessed by Patient Health Questionnaire (PHQ) 9-item Total Score","description":"Change from baseline in participant-reported depressive symptoms as assessed by PHQ 9-item total score was reported. The PHQ-9 is a validated 9-item, patient-reported outcome (PRO) measure to assess depressive symptoms. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27).","timeFrame":"Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32"},{"measure":"Change From Baseline in Participant-reported Depressive Symptoms as Assessed by PHQ 9-item Total Score at LOCF","description":"Change from baseline in participant-reported depressive symptoms as assessed by PHQ 9-item total score at LOCF was reported. The PHQ-9 is a validated 9-item, PRO measure to assess depressive symptoms. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27). LOCF is defined as participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","timeFrame":"Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32"},{"measure":"Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by Sheehan Disability Scale (SDS) Total Score","description":"Change from baseline in participant-reported functional impairment and associated disability as assessed by SDS total score was reported. The SDS is a validated PRO measure consisting of a 5-item questionnaire that has been widely used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a rating scale from 0 to 10. It also has 1 item assessing days lost from school or work and 1 item assessing days of underproductivity. The scores for the first 3 items are summed to create a total score of 0 to 30, where higher score indicates greater impairment. Scores \\<=2 for each item and \\<= 6 for the total score are considered functional remission.","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by SDS Total Score at LOCF","description":"Change from baseline in participant-reported functional impairment and associated disability as assessed by SDS total score at LOCF was reported. The SDS is a validated PRO measure consisting of a 5-item questionnaire for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a rating scale from 0 to 10. It also has 1 item assessing days lost from school or work and 1 item assessing days of underproductivity. The scores for the first 3 items are summed to create a total score of 0 to 30, where higher score indicates greater impairment. Scores \\<=2 for each item and \\<= 6 for the total score are considered functional remission. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","timeFrame":"Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported Health-related Quality of Life (HRQoL) and Health Status as Assessed by 36-item Short-Form Health Survey (SF-36) Scale Score","description":"Change from baseline in participant-reported HRQoL and health status as assessed by SF-36 scale score was reported. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using likert-type responses (for example: none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQoL, 100=best HRQoL. Higher scores indicate better health status.","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported HRQoL and Health Status as Assessed by SF-36 Scale Score at LOCF","description":"Change from baseline in participant-reported HRQoL and health status as assessed by SF-36 domain scores at LOCF was reported. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using likert-type responses (for example: none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQoL, 100=best HRQoL. Higher scores indicate better health status. LOCF is defined as participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","timeFrame":"Baseline, LOCF at Weeks 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported Quality of Life as Assessed by Quality of Life in Depression Scale (QLDS) Total Score","description":"Change from baseline in participant-reported quality of life as assessed by QLDS total score was reported. The QLDS is a disease-specific validated PRO measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of \"1\" or \"0\". A score of \"1\" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition.","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported Quality of Life as Assessed by QLDS Total Score at LOCF","description":"Change from baseline in participant-reported quality of life as assessed by QLDS total score at LOCF was reported. The QLDS is a disease-specific validated PRO measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of \"1\" or \"0\". A score of \"1\" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","timeFrame":"Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score: Health Status Index","description":"Change from baseline in participant-reported health-related quality of Life as assessed by EQ-5D-5L score: health status index was reported. The EQ-5D-5L is a standardized 2-part instrument used to measure health outcomes, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (level 1 = no problem, level 2 = slight problems, level 3 = moderate problems, level 4 = severe problems, level 5 = extreme problems). The participant selects an answer for each of the 5 dimensions considering the response that best matches his or her health \"today.\" Responses were used to generate health status index which ranges from 0 (dead) and 1 (full health), a lower score indicates worse health.","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported Health-related Quality of Life Group, as Assessed by EQ-5D-5L Score: Health Status Index at LOCF","description":"Change from baseline in participant-reported health-related quality of Life as assessed by EQ-5D-5L score: health status index at LOCF was reported. The EQ-5D-5L is a standardized 2-part instrument used to measure health outcomes, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (level 1 = no problem, level 2 = slight problems, level 3 = moderate problems, level 4 = severe problems, level 5 = extreme problems). The participant selects an answer for each of the 5 dimensions considering the response that best matches his or her health \"today.\" LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","timeFrame":"Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS","description":"Change from baseline in participant-reported health status as assessed by EQ-5D-5L Score: VAS was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement.","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS at LOCF","description":"Change from baseline in participant-reported health status as assessed by EQ-5D-5L score: VAS at LOCF was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","timeFrame":"Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported Work Productivity as Assessed by Work Productivity and Activity Impairment (WPAI): Depression Questionnaire","description":"Change from baseline in participant-reported work productivity as assessed by WPAI: depression questionnaire was reported. The WPAI-D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores were derived only for respondents who were working (should be missing for non-working), but the last score was applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Change From Baseline in Participant-reported Work Productivity as Assessed by WPAI: Depression Questionnaire at LOCF","description":"Change from baseline in participant-reported work productivity as assessed by WPAI: depression questionnaire at LOCF was reported. The WPAI-D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores were derived only for respondents who were working (should be missing for non-working), but the last score was applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","timeFrame":"Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32"},{"measure":"Number of Participants With Treatment-emergent Adverse Events (TEAEs)","description":"An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs were those events if they started after administration of the first dose until 14 days after the last dose of study medication for other TEAEs except serious; and first dose until 30 days after the last dose of study medication for serious TEAEs.","timeFrame":"Up to Week 35"},{"measure":"Number of Participants With TEAEs of Special Interest","description":"Number of participants with TEAEs of special interest were reported. It included significant TEAEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Events such as sedation, depersonalization/derealization disorder, depression suicidal, aggression, allergic cystitis, cholestasis and jaundice of hepatic origin, and many more were considered as TEAEs of special interest.","timeFrame":"Up to Week 35"},{"measure":"Number of Participants With Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score","description":"Number of participants with suicidal ideation or behavior as assessed by C-SSRS score was reported. The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Suicidal ideation consists of 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 consists of 5 items: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and completed suicide. The maximum score (from the 10 categories) assigned for each participant was summarized into one of three broad categories: No suicidal ideation or behavior (0), Suicidal ideation (1 - 5), Suicidal behavior (6 - 10). Total score ranges from 1 to 10. Higher scores indicate more severe suicidal ideation and behavior.","timeFrame":"Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* At screening, each participant must meet Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features, based on clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI)\n* At screening and baseline, each participant must have an Inventory of Depressive Symptomatology - Clinician-rated, 30 item (IDS-C30) total score of greater than or equal to (\\>=) 34\n* Must be on a current antidepressive treatment that includes an selective serotonin reuptake inhibitor (SSRI)/ serotonin-norepinephrine reuptake inhibitor (SNRI) at screening that resulted in nonresponse (less than 25% improvement of symptoms) after having been given at an adequate dosage (based on antidepressive dosages from SmPC \\[or local equivalent, if applicable\\]) for an adequate duration of at least 6 weeks and having been uptitrated to the maximum tolerated dose; however, at screening the participant must show signs of minimal clinical improvement to be eligible for the study. Clinical improvement of a participant on their current AD treatment will be retrospectively evaluated in a qualified psychiatric interview performed by an experienced clinician. 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Trajectory of response to esketamine nasal spray for treatment resistant depression: Findings from ESCAPE-TRD. Eur Psychiatry. 2026 Jun 16;69(1):e74. doi: 10.1192/j.eurpsy.2026.12229."},{"pmid":"38954874","type":"DERIVED","citation":"McIntyre RS, Bitter I, Buyze J, Fagiolini A, Godinov Y, Gorwood P, Ito T, Oliveira-Maia AJ, Vieta E, Werner-Kiechle T, Young AH, Reif A. Safety and tolerability of esketamine nasal spray versus quetiapine extended release in patients with treatment resistant depression. Eur Neuropsychopharmacol. 2024 Aug;85:58-65. doi: 10.1016/j.euroneuro.2024.05.009. Epub 2024 Jul 1."},{"pmid":"38169503","type":"DERIVED","citation":"Lan CH, Wei JC. Esketamine Nasal Spray versus Quetiapine for Resistant Depression. N Engl J Med. 2024 Jan 4;390(1):93-94. doi: 10.1056/NEJMc2313230. No abstract available."},{"pmid":"38169502","type":"DERIVED","citation":"Horowitz MA, Ploderl M, Naudet F. Esketamine Nasal Spray versus Quetiapine for Resistant Depression. N Engl J Med. 2024 Jan 4;390(1):93. doi: 10.1056/NEJMc2313230. No abstract available."},{"pmid":"37792613","type":"DERIVED","citation":"Reif A, Bitter I, Buyze J, Cebulla K, Frey R, Fu DJ, Ito T, Kambarov Y, Llorca PM, Oliveira-Maia AJ, Messer T, Mulhern-Haughey S, Rive B, von Holt C, Young AH, Godinov Y; ESCAPE-TRD Investigators. Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression. N Engl J Med. 2023 Oct 5;389(14):1298-1309. doi: 10.1056/NEJMoa2304145."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \\& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu","url":"https://www.janssen.com/clinical-trials/transparency"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants who discontinued the treatment early still remained in the study and were followed up until the end of study.","groups":[{"id":"FG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"FG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"336"},{"groupId":"FG001","numSubjects":"340"}]},{"type":"Treated (Safety Analysis Set)","achievements":[{"groupId":"FG000","numSubjects":"334"},{"groupId":"FG001","numSubjects":"336"}]},{"type":"Completed Treatment","achievements":[{"groupId":"FG000","numSubjects":"258"},{"groupId":"FG001","numSubjects":"203"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"274"},{"groupId":"FG001","numSubjects":"232"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"62"},{"groupId":"FG001","numSubjects":"108"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"69"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"10"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"BG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"336"},{"groupId":"BG001","value":"340"},{"groupId":"BG002","value":"676"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.3","spread":"13.6"},{"groupId":"BG001","value":"45.7","spread":"13.38"},{"groupId":"BG002","value":"45","spread":"13.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"225"},{"groupId":"BG001","value":"222"},{"groupId":"BG002","value":"447"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"111"},{"groupId":"BG001","value":"118"},{"groupId":"BG002","value":"229"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"19"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"12"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"137"},{"groupId":"BG001","value":"152"},{"groupId":"BG002","value":"289"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"185"},{"groupId":"BG001","value":"171"},{"groupId":"BG002","value":"356"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage of Participants With Remission as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Score at Week 8","description":"Percentage of participants with remission as assessed by the MADRS at Week 8 was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is 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 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. A participant was defined as being in remission if the MADRS total score was less than or equal to (\\<=)10 and no treatment or study discontinuation before Week 8.","populationDescription":"The full analysis set (FAS) included all randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"336"},{"groupId":"OG001","value":"340"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27.1"},{"groupId":"OG001","value":"17.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.003","statisticalMethod":"Cochran-Mantel-Haenszel","paramType":"Mean Difference (Final Values)","paramValue":"9.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.19","ciUpperLimit":"15.68"}]},{"type":"SECONDARY","title":"Percentage of Participants With Both Remission at Week 8 and Relapse-free Until Week 32","description":"Percentage of participants with both remission at Week 8 and relapse-free until Week 32 were reported. A participant was defined as being in remission if the MADRS total score was \\<= 10 and no treatment or study discontinuation before Week 8. A relapse was defined by any of following: a) Worsening of depressive symptoms as indicated by MADRS total score greater than or equal to (\\>=) 22 confirmed by 1 additional assessment of MADRS total score \\>= 22 within the next 5 to 15 days. The date of the second MADRS assessment was used for the date of relapse; b) Any psychiatric hospitalization for: worsening of depression, suicide prevention or suicide attempt, the start date of hospitalization was the date of relapse; c) Suicide attempt, completed suicide, or any other clinically relevant event determined by investigator's judgment to be indicative of a relapse of depressive illness, but without hospitalized. The onset of the event was used for the date of relapse.","populationDescription":"The FAS includes all randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"336"},{"groupId":"OG001","value":"340"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.7"},{"groupId":"OG001","value":"14.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Clinician-rated Overall MADRS Score","description":"Change from baseline in clinician-rated overall MADRS score was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, 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. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Unit on scale","timeFrame":"Baseline, Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"330"}]}],"classes":[{"title":"Week 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"326"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-5.3","spread":"5.71"},{"groupId":"OG001","value":"-3.7","spread":"4.65"}]}]},{"title":"Week 2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"324"},{"groupId":"OG001","value":"315"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-9.0","spread":"6.87"},{"groupId":"OG001","value":"-6.1","spread":"6.52"}]}]},{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"317"},{"groupId":"OG001","value":"295"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-12.8","spread":"7.50"},{"groupId":"OG001","value":"-9.8","spread":"7.32"}]}]},{"title":"Week 6","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"312"},{"groupId":"OG001","value":"285"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-14.9","spread":"8.27"},{"groupId":"OG001","value":"-12.2","spread":"8.11"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"300"},{"groupId":"OG001","value":"265"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-16.4","spread":"8.67"},{"groupId":"OG001","value":"-14.3","spread":"8.26"}]}]},{"title":"Week 10","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"288"},{"groupId":"OG001","value":"242"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-18.2","spread":"8.32"},{"groupId":"OG001","value":"-16.2","spread":"7.38"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"235"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-18.4","spread":"8.26"},{"groupId":"OG001","value":"-16.7","spread":"8.16"}]}]},{"title":"Week 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"280"},{"groupId":"OG001","value":"232"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-19.0","spread":"8.06"},{"groupId":"OG001","value":"-17.1","spread":"8.06"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"223"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-19.6","spread":"8.16"},{"groupId":"OG001","value":"-17.8","spread":"8.23"}]}]},{"title":"Week 18","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"219"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-19.9","spread":"8.59"},{"groupId":"OG001","value":"-18.1","spread":"8.36"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"269"},{"groupId":"OG001","value":"214"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-20.1","spread":"8.75"},{"groupId":"OG001","value":"-19.1","spread":"8.11"}]}]},{"title":"Week 22","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"214"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-20.6","spread":"8.32"},{"groupId":"OG001","value":"-19.5","spread":"8.04"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"259"},{"groupId":"OG001","value":"209"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-21.0","spread":"8.58"},{"groupId":"OG001","value":"-20.1","spread":"7.96"}]}]},{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"257"},{"groupId":"OG001","value":"206"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-21.2","spread":"8.19"},{"groupId":"OG001","value":"-20.0","spread":"8.18"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"205"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-21.5","spread":"8.33"},{"groupId":"OG001","value":"-20.8","spread":"8.33"}]}]},{"title":"Week 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"250"},{"groupId":"OG001","value":"200"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-21.8","spread":"8.66"},{"groupId":"OG001","value":"-20.6","spread":"8.39"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"255"},{"groupId":"OG001","value":"203"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-22.2","spread":"8.12"},{"groupId":"OG001","value":"-20.5","spread":"8.58"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Clinician-rated Overall MADRS Score at Last Observation Carried Forward (LOCF)","description":"Change from baseline in clinician-rated overall MADRS score at LOCF was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, 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. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","populationDescription":"The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Unit on scale","timeFrame":"Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"330"}]}],"classes":[{"title":"Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"-9.0","spread":"6.86"},{"groupId":"OG001","value":"-5.8","spread":"6.53"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-12.6","spread":"7.63"},{"groupId":"OG001","value":"-8.9","spread":"7.70"}]}]},{"title":"Week 6","categories":[{"measurements":[{"groupId":"OG000","value":"-14.5","spread":"8.47"},{"groupId":"OG001","value":"-10.7","spread":"8.78"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"-15.7","spread":"9.07"},{"groupId":"OG001","value":"-12.0","spread":"9.30"}]}]},{"title":"Week 10","categories":[{"measurements":[{"groupId":"OG000","value":"-16.9","spread":"9.15"},{"groupId":"OG001","value":"-12.8","spread":"9.24"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-17.1","spread":"9.22"},{"groupId":"OG001","value":"-13.1","spread":"9.82"}]}]},{"title":"Week 14","categories":[{"measurements":[{"groupId":"OG000","value":"-17.6","spread":"9.08"},{"groupId":"OG001","value":"-13.2","spread":"9.88"}]}]},{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-18.1","spread":"9.24"},{"groupId":"OG001","value":"-13.7","spread":"10.17"}]}]},{"title":"Week 18","categories":[{"measurements":[{"groupId":"OG000","value":"-18.1","spread":"9.60"},{"groupId":"OG001","value":"-13.8","spread":"10.26"}]}]},{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-18.2","spread":"9.80"},{"groupId":"OG001","value":"-14.3","spread":"10.46"}]}]},{"title":"Week 22","categories":[{"measurements":[{"groupId":"OG000","value":"-18.7","spread":"9.83"},{"groupId":"OG001","value":"-14.6","spread":"10.56"}]}]},{"title":"Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"-18.8","spread":"9.88"},{"groupId":"OG001","value":"-14.8","spread":"10.77"}]}]},{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-19.0","spread":"9.76"},{"groupId":"OG001","value":"-14.9","spread":"10.76"}]}]},{"title":"Week 28","categories":[{"measurements":[{"groupId":"OG000","value":"-19.1","spread":"9.88"},{"groupId":"OG001","value":"-15.2","spread":"11.08"}]}]},{"title":"Week 30","categories":[{"measurements":[{"groupId":"OG000","value":"-19.2","spread":"10.10"},{"groupId":"OG001","value":"-15.2","spread":"11.11"}]}]},{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"-19.6","spread":"9.94"},{"groupId":"OG001","value":"-15.1","spread":"11.18"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Severity (CGI-S) Scale Score","description":"Change from baseline in clinician-rated overall severity of depressive illness as assessed by CGI-S scale score was reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes 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 evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative change in score indicates improvement.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on scale","timeFrame":"Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"331"}]}],"classes":[{"title":"Week 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"327"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"0.58"},{"groupId":"OG001","value":"-0.2","spread":"0.53"}]}]},{"title":"Week 2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"324"},{"groupId":"OG001","value":"314"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"0.79"},{"groupId":"OG001","value":"-0.5","spread":"0.77"}]}]},{"title":"Week 3","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"313"},{"groupId":"OG001","value":"302"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"0.88"},{"groupId":"OG001","value":"-0.7","spread":"0.83"}]}]},{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"317"},{"groupId":"OG001","value":"296"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"0.94"},{"groupId":"OG001","value":"-1.0","spread":"0.95"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"300"},{"groupId":"OG001","value":"265"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.7","spread":"0.98"},{"groupId":"OG001","value":"-1.4","spread":"1.05"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"286"},{"groupId":"OG001","value":"238"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.9","spread":"1.00"},{"groupId":"OG001","value":"-1.7","spread":"1.07"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"280"},{"groupId":"OG001","value":"229"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.1","spread":"1.05"},{"groupId":"OG001","value":"-1.9","spread":"1.15"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"218"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"1.04"},{"groupId":"OG001","value":"-2.0","spread":"1.22"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"260"},{"groupId":"OG001","value":"213"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.3","spread":"1.06"},{"groupId":"OG001","value":"-2.1","spread":"1.22"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"255"},{"groupId":"OG001","value":"208"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.4","spread":"1.02"},{"groupId":"OG001","value":"-2.2","spread":"1.19"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"255"},{"groupId":"OG001","value":"203"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.5","spread":"1.05"},{"groupId":"OG001","value":"-2.3","spread":"1.21"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-S Scale Score at LOCF","description":"Change from Baseline in clinician-rated overall severity of depressive illness as assessed by CGI-S scale score at LOCF was reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes 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 evaluates the severity of psychopathology on a scale of 1 to 7. A participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","populationDescription":"The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on scale","timeFrame":"Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"331"}]}],"classes":[{"title":"Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"0.79"},{"groupId":"OG001","value":"-0.5","spread":"0.75"}]}]},{"title":"Week 3","categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"0.88"},{"groupId":"OG001","value":"-0.7","spread":"0.84"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-1.3","spread":"0.95"},{"groupId":"OG001","value":"-0.9","spread":"0.96"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"1.02"},{"groupId":"OG001","value":"-1.2","spread":"1.10"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"1.09"},{"groupId":"OG001","value":"-1.3","spread":"1.18"}]}]},{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-1.9","spread":"1.16"},{"groupId":"OG001","value":"-1.4","spread":"1.26"}]}]},{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","spread":"1.17"},{"groupId":"OG001","value":"-1.5","spread":"1.32"}]}]},{"title":"Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"-2.1","spread":"1.22"},{"groupId":"OG001","value":"-1.5","spread":"1.35"}]}]},{"title":"Week 28","categories":[{"measurements":[{"groupId":"OG000","value":"-2.1","spread":"1.22"},{"groupId":"OG001","value":"-1.6","spread":"1.36"}]}]},{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"1.27"},{"groupId":"OG001","value":"-1.6","spread":"1.40"}]}]}]},{"type":"SECONDARY","title":"Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Change (CGI-C) Scale Score","description":"Clinician-rated overall severity of depressive illness as assessed by CGI-C scale score was reported. The CGI-C evaluates the total improvement whether or not entirely due to drug treatment on a scale of 1 to 7. Compared to the condition at baseline, a participant is assessed on how much he/she has changed, according to: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Higher scores indicate more severity.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on scale","timeFrame":"Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"331"}]}],"classes":[{"title":"Week 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"327"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.3","spread":"0.77"},{"groupId":"OG001","value":"3.6","spread":"0.72"}]}]},{"title":"Week 2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"324"},{"groupId":"OG001","value":"314"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.9","spread":"0.87"},{"groupId":"OG001","value":"3.3","spread":"0.85"}]}]},{"title":"Week 3","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"313"},{"groupId":"OG001","value":"302"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.7","spread":"0.83"},{"groupId":"OG001","value":"3.1","spread":"0.84"}]}]},{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"317"},{"groupId":"OG001","value":"296"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.4","spread":"0.85"},{"groupId":"OG001","value":"2.9","spread":"0.96"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"300"},{"groupId":"OG001","value":"265"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"0.84"},{"groupId":"OG001","value":"2.4","spread":"0.93"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"286"},{"groupId":"OG001","value":"239"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.0","spread":"0.85"},{"groupId":"OG001","value":"2.3","spread":"0.89"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"280"},{"groupId":"OG001","value":"229"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.9","spread":"0.87"},{"groupId":"OG001","value":"2.2","spread":"0.99"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"218"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.8","spread":"0.85"},{"groupId":"OG001","value":"2.1","spread":"0.92"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"260"},{"groupId":"OG001","value":"213"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.8","spread":"0.85"},{"groupId":"OG001","value":"2.0","spread":"0.84"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"255"},{"groupId":"OG001","value":"208"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.7","spread":"0.84"},{"groupId":"OG001","value":"2.0","spread":"0.91"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"255"},{"groupId":"OG001","value":"203"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.6","spread":"0.81"},{"groupId":"OG001","value":"1.9","spread":"0.88"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-C Scale Score at LOCF","description":"Number of participants with clinician-rated overall severity of depressive illness as assessed by CGI-C scale score at LOCF was reported. The CGI-C evaluates the total improvement whether or not entirely due to drug treatment on a scale of 1 to 7. Compared to the condition at baseline, a participant is assessed on how much he/she has changed, according to: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Higher scores indicate more severity. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","populationDescription":"The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"331"}]}],"classes":[{"title":"Very much improved at Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"}]}]},{"title":"Much improved at Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"39"}]}]},{"title":"Minimally improved at Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"149"}]}]},{"title":"No change at Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"108"}]}]},{"title":"Minimally worse at Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"26"}]}]},{"title":"Much worse at Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"5"}]}]},{"title":"Very much worse at Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"Very much improved at Week 3","categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"8"}]}]},{"title":"Much improved at Week 3","categories":[{"measurements":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"57"}]}]},{"title":"Minimally improved at Week 3","categories":[{"measurements":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"159"}]}]},{"title":"No change at Week 3","categories":[{"measurements":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"81"}]}]},{"title":"Minimally worse at Week 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The PHQ-9 is a validated 9-item, patient-reported outcome (PRO) measure to assess depressive symptoms. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27).","populationDescription":"The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. 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In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"322"},{"groupId":"OG001","value":"316"}]}],"classes":[{"title":"Week 2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"310"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.9","spread":"4.90"},{"groupId":"OG001","value":"-3.1","spread":"4.62"}]}]},{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"291"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.7","spread":"5.25"},{"groupId":"OG001","value":"-5.0","spread":"5.06"}]}]},{"title":"Week 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The PHQ-9 is a validated 9-item, PRO measure to assess depressive symptoms. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27). LOCF is defined as participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on scale","timeFrame":"Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"322"},{"groupId":"OG001","value":"316"}]}],"classes":[{"title":"Week 2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"310"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.9","spread":"4.90"},{"groupId":"OG001","value":"-3.1","spread":"4.62"}]}]},{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"314"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.6","spread":"5.33"},{"groupId":"OG001","value":"-4.7","spread":"5.06"}]}]},{"title":"Week 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The SDS is a validated PRO measure consisting of a 5-item questionnaire that has been widely used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a rating scale from 0 to 10. It also has 1 item assessing days lost from school or work and 1 item assessing days of underproductivity. The scores for the first 3 items are summed to create a total score of 0 to 30, where higher score indicates greater impairment. Scores \\<=2 for each item and \\<= 6 for the total score are considered functional remission.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on scale","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"303"}]}],"classes":[{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"307"},{"groupId":"OG001","value":"298"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-5.9","spread":"6.58"},{"groupId":"OG001","value":"-4.1","spread":"5.89"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"284"},{"groupId":"OG001","value":"252"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.6","spread":"7.03"},{"groupId":"OG001","value":"-6.8","spread":"7.63"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"232"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-9.7","spread":"7.54"},{"groupId":"OG001","value":"-8.6","spread":"6.94"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"219"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-10.6","spread":"7.29"},{"groupId":"OG001","value":"-9.0","spread":"7.50"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"208"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-10.9","spread":"7.57"},{"groupId":"OG001","value":"-9.0","spread":"7.41"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"201"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.2","spread":"7.88"},{"groupId":"OG001","value":"-10.1","spread":"7.76"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"245"},{"groupId":"OG001","value":"200"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.9","spread":"7.84"},{"groupId":"OG001","value":"-10.8","spread":"8.03"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"244"},{"groupId":"OG001","value":"193"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-12.6","spread":"8.09"},{"groupId":"OG001","value":"-11.1","spread":"8.06"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by SDS Total Score at LOCF","description":"Change from baseline in participant-reported functional impairment and associated disability as assessed by SDS total score at LOCF was reported. The SDS is a validated PRO measure consisting of a 5-item questionnaire for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a rating scale from 0 to 10. It also has 1 item assessing days lost from school or work and 1 item assessing days of underproductivity. The scores for the first 3 items are summed to create a total score of 0 to 30, where higher score indicates greater impairment. Scores \\<=2 for each item and \\<= 6 for the total score are considered functional remission. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on scale","timeFrame":"Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"303"}]}],"classes":[{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"307"},{"groupId":"OG001","value":"298"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-5.9","spread":"6.58"},{"groupId":"OG001","value":"-4.1","spread":"5.89"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"309"},{"groupId":"OG001","value":"303"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.2","spread":"7.06"},{"groupId":"OG001","value":"-5.8","spread":"7.45"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"303"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-9.0","spread":"7.59"},{"groupId":"OG001","value":"-6.8","spread":"7.59"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"303"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-9.8","spread":"7.47"},{"groupId":"OG001","value":"-7.0","spread":"7.99"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"303"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-9.9","spread":"7.75"},{"groupId":"OG001","value":"-7.0","spread":"7.97"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"303"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-10.0","spread":"8.13"},{"groupId":"OG001","value":"-7.6","spread":"8.37"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"303"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-10.4","spread":"8.21"},{"groupId":"OG001","value":"-7.9","spread":"8.69"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"303"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.1","spread":"8.56"},{"groupId":"OG001","value":"-8.2","spread":"8.78"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Participant-reported Health-related Quality of Life (HRQoL) and Health Status as Assessed by 36-item Short-Form Health Survey (SF-36) Scale Score","description":"Change from baseline in participant-reported HRQoL and health status as assessed by SF-36 scale score was reported. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using likert-type responses (for example: none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQoL, 100=best HRQoL. Higher scores indicate better health status.","populationDescription":"The FAS included all randomized participants. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified categories with time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on scale","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"308"}]}],"classes":[{"title":"Physical Functioning Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"295"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.5","spread":"7.16"},{"groupId":"OG001","value":"2.2","spread":"6.85"}]}]},{"title":"Physical Functioning Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"287"},{"groupId":"OG001","value":"250"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.4","spread":"7.64"},{"groupId":"OG001","value":"3.8","spread":"8.19"}]}]},{"title":"Physical Functioning Week 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Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified categories with time points. LOCF was applied only for participants whose questionnaire was completely missing. No LOCF imputation was done on partially completed questionnaire.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on scale","timeFrame":"Baseline, LOCF at Weeks 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"308"}]}],"classes":[{"title":"Physical Functioning Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"308"},{"groupId":"OG001","value":"300"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.1","spread":"7.61"},{"groupId":"OG001","value":"3.2","spread":"8.15"}]}]},{"title":"Physical Functioning Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"308"},{"groupId":"OG001","value":"299"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.3","spread":"8.22"},{"groupId":"OG001","value":"3.9","spread":"7.96"}]}]},{"title":"Physical Functioning Week 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16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"317"},{"groupId":"OG001","value":"307"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14.2","spread":"11.53"},{"groupId":"OG001","value":"10.3","spread":"12.32"}]}]},{"title":"Role-Emotional Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"317"},{"groupId":"OG001","value":"305"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14.3","spread":"11.77"},{"groupId":"OG001","value":"10.4","spread":"11.67"}]}]},{"title":"Role-Emotional Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"316"},{"groupId":"OG001","value":"306"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14.3","spread":"12.15"},{"groupId":"OG001","value":"11.2","spread":"12.22"}]}]},{"title":"Role-Emotional Week 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Score","description":"Change from baseline in participant-reported quality of life as assessed by QLDS total score was reported. The QLDS is a disease-specific validated PRO measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of \"1\" or \"0\". A score of \"1\" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on Scale","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"305"}]}],"classes":[{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"315"},{"groupId":"OG001","value":"300"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.9","spread":"8.83"},{"groupId":"OG001","value":"-5.6","spread":"7.43"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"292"},{"groupId":"OG001","value":"253"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-12.0","spread":"9.36"},{"groupId":"OG001","value":"-9.1","spread":"9.31"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"234"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-13.5","spread":"9.30"},{"groupId":"OG001","value":"-10.9","spread":"9.52"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"221"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-14.2","spread":"9.39"},{"groupId":"OG001","value":"-11.6","spread":"9.39"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"212"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-14.3","spread":"9.50"},{"groupId":"OG001","value":"-12.1","spread":"9.74"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"256"},{"groupId":"OG001","value":"205"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-14.9","spread":"9.44"},{"groupId":"OG001","value":"-12.8","spread":"9.64"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"201"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-15.6","spread":"9.42"},{"groupId":"OG001","value":"-13.7","spread":"9.51"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"198"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-16.0","spread":"9.55"},{"groupId":"OG001","value":"-14.2","spread":"9.96"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Participant-reported Quality of Life as Assessed by QLDS Total Score at LOCF","description":"Change from baseline in participant-reported quality of life as assessed by QLDS total score at LOCF was reported. The QLDS is a disease-specific validated PRO measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of \"1\" or \"0\". A score of \"1\" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on Scale","timeFrame":"Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"305"}]}],"classes":[{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"315"},{"groupId":"OG001","value":"300"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.9","spread":"8.83"},{"groupId":"OG001","value":"-5.6","spread":"7.43"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"305"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.3","spread":"9.59"},{"groupId":"OG001","value":"-8.1","spread":"9.22"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"305"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-12.3","spread":"9.73"},{"groupId":"OG001","value":"-9.0","spread":"9.62"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"305"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-13.0","spread":"9.86"},{"groupId":"OG001","value":"-9.3","spread":"9.80"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"305"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-13.0","spread":"9.93"},{"groupId":"OG001","value":"-9.5","spread":"10.02"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"305"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-13.3","spread":"9.98"},{"groupId":"OG001","value":"-9.8","spread":"10.18"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"305"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-13.6","spread":"10.06"},{"groupId":"OG001","value":"-10.3","spread":"10.26"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"305"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-14.1","spread":"10.29"},{"groupId":"OG001","value":"-10.5","spread":"10.59"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Participant-reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score: Health Status Index","description":"Change from baseline in participant-reported health-related quality of Life as assessed by EQ-5D-5L score: health status index was reported. The EQ-5D-5L is a standardized 2-part instrument used to measure health outcomes, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (level 1 = no problem, level 2 = slight problems, level 3 = moderate problems, level 4 = severe problems, level 5 = extreme problems). The participant selects an answer for each of the 5 dimensions considering the response that best matches his or her health \"today.\" Responses were used to generate health status index which ranges from 0 (dead) and 1 (full health), a lower score indicates worse health.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on Scale","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"308"}]}],"classes":[{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"306"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.177","spread":"0.2354"},{"groupId":"OG001","value":"0.124","spread":"0.2280"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"296"},{"groupId":"OG001","value":"258"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.234","spread":"0.2655"},{"groupId":"OG001","value":"0.206","spread":"0.2463"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"282"},{"groupId":"OG001","value":"237"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.276","spread":"0.2405"},{"groupId":"OG001","value":"0.227","spread":"0.2367"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"225"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.284","spread":"0.2445"},{"groupId":"OG001","value":"0.232","spread":"0.2431"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"214"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.294","spread":"0.2399"},{"groupId":"OG001","value":"0.238","spread":"0.2423"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"209"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.297","spread":"0.2498"},{"groupId":"OG001","value":"0.259","spread":"0.2489"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"250"},{"groupId":"OG001","value":"205"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.303","spread":"0.2584"},{"groupId":"OG001","value":"0.262","spread":"0.2492"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"254"},{"groupId":"OG001","value":"200"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.317","spread":"0.2636"},{"groupId":"OG001","value":"0.279","spread":"0.2581"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Participant-reported Health-related Quality of Life Group, as Assessed by EQ-5D-5L Score: Health Status Index at LOCF","description":"Change from baseline in participant-reported health-related quality of Life as assessed by EQ-5D-5L score: health status index at LOCF was reported. The EQ-5D-5L is a standardized 2-part instrument used to measure health outcomes, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (level 1 = no problem, level 2 = slight problems, level 3 = moderate problems, level 4 = severe problems, level 5 = extreme problems). The participant selects an answer for each of the 5 dimensions considering the response that best matches his or her health \"today.\" LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on Scale","timeFrame":"Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"308"}]}],"classes":[{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"306"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.177","spread":"0.2354"},{"groupId":"OG001","value":"0.124","spread":"0.2280"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"308"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.221","spread":"0.2681"},{"groupId":"OG001","value":"0.175","spread":"0.2510"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"308"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.247","spread":"0.2552"},{"groupId":"OG001","value":"0.187","spread":"0.2523"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"308"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.255","spread":"0.2580"},{"groupId":"OG001","value":"0.188","spread":"0.2595"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"308"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.261","spread":"0.2600"},{"groupId":"OG001","value":"0.187","spread":"0.2590"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"308"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.264","spread":"0.2627"},{"groupId":"OG001","value":"0.196","spread":"0.2671"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"308"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.266","spread":"0.2739"},{"groupId":"OG001","value":"0.195","spread":"0.2664"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"308"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.280","spread":"0.2806"},{"groupId":"OG001","value":"0.207","spread":"0.2739"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS","description":"Change from baseline in participant-reported health status as assessed by EQ-5D-5L Score: VAS was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on Scale","timeFrame":"Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"310"}]}],"classes":[{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"317"},{"groupId":"OG001","value":"308"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13.3","spread":"18.43"},{"groupId":"OG001","value":"9.7","spread":"17.83"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"293"},{"groupId":"OG001","value":"256"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"18.9","spread":"19.84"},{"groupId":"OG001","value":"16.1","spread":"19.64"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"280"},{"groupId":"OG001","value":"238"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20.9","spread":"20.98"},{"groupId":"OG001","value":"17.2","spread":"20.73"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"225"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"21.9","spread":"20.14"},{"groupId":"OG001","value":"20.2","spread":"22.14"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"215"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"22.3","spread":"21.20"},{"groupId":"OG001","value":"19.6","spread":"21.59"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"257"},{"groupId":"OG001","value":"208"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"23.6","spread":"20.95"},{"groupId":"OG001","value":"21.8","spread":"21.60"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"205"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"25.2","spread":"20.95"},{"groupId":"OG001","value":"23.2","spread":"22.11"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"201"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"24.9","spread":"21.65"},{"groupId":"OG001","value":"24.5","spread":"22.64"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS at LOCF","description":"Change from baseline in participant-reported health status as assessed by EQ-5D-5L score: VAS at LOCF was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.","populationDescription":"The FAS included all randomized participants. Here, 'N' (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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on Scale","timeFrame":"Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"310"}]}],"classes":[{"title":"Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"317"},{"groupId":"OG001","value":"308"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13.3","spread":"18.43"},{"groupId":"OG001","value":"9.7","spread":"17.83"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"310"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"18.2","spread":"19.94"},{"groupId":"OG001","value":"14.0","spread":"20.42"}]}]},{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"310"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"19.4","spread":"21.04"},{"groupId":"OG001","value":"14.4","spread":"21.19"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"310"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20.2","spread":"20.37"},{"groupId":"OG001","value":"16.1","spread":"22.42"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"310"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20.4","spread":"21.34"},{"groupId":"OG001","value":"15.4","spread":"22.19"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"310"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"21.3","spread":"21.34"},{"groupId":"OG001","value":"16.9","spread":"22.64"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"310"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"21.9","spread":"21.78"},{"groupId":"OG001","value":"17.3","spread":"23.10"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"310"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"22.3","spread":"22.47"},{"groupId":"OG001","value":"18.0","spread":"23.59"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Participant-reported Work Productivity as Assessed by Work Productivity and Activity Impairment (WPAI): Depression Questionnaire","description":"Change from baseline in participant-reported work productivity as assessed by WPAI: depression questionnaire was reported. 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In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"307"}]}],"classes":[{"title":"Absenteeism Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"112"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.95","spread":"20.745"},{"groupId":"OG001","value":"-8.37","spread":"25.790"}]}]},{"title":"Absenteeism Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"91"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-19.02","spread":"30.205"},{"groupId":"OG001","value":"-13.62","spread":"31.059"}]}]},{"title":"Absenteeism Week 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Here, 'N' (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. LOCF was applied only for participants whose questionnaire was completely missing. No LOCF imputation was done on partially completed questionnaire.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on scale","timeFrame":"Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"307"}]}],"classes":[{"title":"Absenteeism Week 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"112"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.95","spread":"20.745"},{"groupId":"OG001","value":"-8.37","spread":"25.790"}]}]},{"title":"Absenteeism Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"107"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-18.28","spread":"29.417"},{"groupId":"OG001","value":"-12.38","spread":"30.369"}]}]},{"title":"Absenteeism Week 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In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"336"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"307"},{"groupId":"OG001","value":"262"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With TEAEs of Special Interest","description":"Number of participants with TEAEs of special interest were reported. It included significant TEAEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Events such as sedation, depersonalization/derealization disorder, depression suicidal, aggression, allergic cystitis, cholestasis and jaundice of hepatic origin, and many more were considered as TEAEs of special interest.","populationDescription":"The safety analysis set included all randomized participants who received at least 1 dose of any study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to Week 35","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"336"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"140"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score","description":"Number of participants with suicidal ideation or behavior as assessed by C-SSRS score was reported. The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. 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Here, 'N' (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.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32","groups":[{"id":"OG000","title":"Esketamine Nasal Spray + Oral Antidepressant (AD)","description":"Participants received treatment with esketamine nasal spray (28 milligrams \\[mg\\] \\[initial dose for elderly participants aged 65 to 74 years and adults of Japanese ancestry\\], 56 mg \\[initial dose for adult participants aged 18 to 64 years\\], or 84 mg \\[maximum dose esketamine nasal spray\\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI)."},{"id":"OG001","title":"Quetiapine Extended Release (XR) + Oral AD","description":"Participants continued to take their current SSRI/SNRI augmented with quetiapine XR as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable) at an initial dose of 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 (lowest effective dose) in adult participants aged 18 to 64 years; a further dose increase to 300 mg/day on Day 5 and onward were based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose was 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day were based on individual participant evaluation no earlier than Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"317"},{"groupId":"OG001","value":"295"}]}],"classes":[{"title":"Suicidal Ideation Week 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"282"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"25"}]}]},{"title":"Suicidal Behavior Week 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"282"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Suicidal Ideation Week 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depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 25.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":1,"numAtRisk":336}]},{"term":"Somatic symptom disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 25.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":334},{"groupId":"EG001","numAffected":0,"numAtRisk":336}]},{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 25.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":334},{"groupId":"EG001","numAffected":3,"numAtRisk":336}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 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