Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-30 @ 12:13 PM
Study NCT ID:
NCT02493868
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2015-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}, {'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}, {'id': 'D000928', 'term': 'Antidepressive Agents'}, {'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Senior Director, Clinical Research', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 years', 'description': 'Safety analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in respective phase (Induction, Optimization, Maintenance). Follow-up analysis set included all participants who entered the follow-up phase.', 'eventGroups': [{'id': 'EG000', 'title': 'IND: Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (direct-entry participants only): received 56 milligram (mg) or 84 mg intranasal esketamine solution twice weekly with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks.', 'otherNumAtRisk': 437, 'deathsNumAtRisk': 437, 'otherNumAffected': 306, 'seriousNumAtRisk': 437, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'OP: Intranasal Esketamine + Oral AD', 'description': 'Optimization (OP) phase (both direct-entry and transferred-entry participants): received 56 mg or 84 mg intranasal esketamine solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks.', 'otherNumAtRisk': 455, 'deathsNumAtRisk': 455, 'otherNumAffected': 279, 'seriousNumAtRisk': 455, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'MA: Intranasal Esketamine + Oral AD', 'description': 'Maintenance (MA) phase (both direct-entry and transferred-entry participants): received 56 mg or 84 mg intranasal esketamine solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily until relapse or study termination.', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 114, 'seriousNumAtRisk': 152, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'MA: Oral AD + Intranasal Placebo', 'description': 'Maintenance phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), until relapse or study termination.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 45, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'FU: Intranasal Esketamine + Oral AD', 'description': 'Participants (who were non-responders in IND phase and who were in OP and MA phase at study termination) who received at least 1 dose of 56 mg or 84 mg intranasal esketamine participated in the follow-up (FU) phase. No intranasal esketamine was administered during FU phase. Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate.', 'otherNumAtRisk': 481, 'deathsNumAtRisk': 481, 'otherNumAffected': 14, 'seriousNumAtRisk': 481, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'FU: Oral AD + Intranasal Placebo', 'description': 'Participants (who were non-responders in IND phase and who were in OP and MA phase at study termination) who received intranasal esketamine matching placebo with oral AD participated in the FU phase. Participants received oral AD for at least the 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 1, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'OP_TEP: Oral AD + Intranasal Placebo', 'description': 'OP phase (transferred-entry participants \\[TEP\\]): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 40, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'MA_TEP: Oral AD + Intranasal Placebo', 'description': 'Maintenance phase (transferred-entry participants): Participants were randomized (at the end of optimization phase) to intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine XR).', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 37, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 91}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Hypoaesthesia Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Paraesthesia Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Dizziness Postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 16}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Dissociation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Nasal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 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{'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Lacunar Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Simple Partial Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Ectopic Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Panic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Clavicle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 455, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 481, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Relapse in Participants With Stable Remission (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Here NA signifies that median and 95%CI was not estimable due to not having sufficient events to meet the threshold for 50% on the Kaplan-Meier curve.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '273.0', 'comment': 'Here NA signifies that upper limit of CI could not be estimated due to insufficient data.', 'groupId': 'OG001', 'lowerLimit': '97.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '= 0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.29', 'ciUpperLimit': '0.84', 'statisticalMethod': 'Weighted Log-rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)', 'description': 'Relapse is defined as any of following: Montgomery-asberg depression rating scale (MADRS) total score greater than or equal to (\\>=) 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable remission: MADRS total score less than or equal to (\\<=) 12 for at least 3 of last 4 weeks of OP phase, with 1 excursion total score greater than (\\>) 12 or one missing assessment at OP week 13 or 14.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full (stable remitters) analysis set included all the randomized participants who were in stable remission at the end of the optimization phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during the maintenance phase.'}, {'type': 'SECONDARY', 'title': 'Time to Relapse in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '635.0', 'groupId': 'OG000', 'lowerLimit': '264.0', 'upperLimit': '635.0'}, {'value': '88.0', 'groupId': 'OG001', 'lowerLimit': '46.0', 'upperLimit': '196.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)', 'description': 'Relapse is defined as any of following: MADRS total score \\>= 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable response is defined as \\>= 50 percent (%) reduction in MADRS total score from baseline (Day 1 of induction phase, prior to first intranasal dose) in each of the last 2 weeks of the OP phase, but without meeting criteria for stable remission.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full (stable responders) analysis set included all randomized participants who were stable responders (who were not stable remitters) at the end of the optimization phase and who received at least 1 dose of intranasal study drug and 1 dose of oral antidepressant during the maintenance phase.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '11.59', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '13.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (last observation carried forward \\[LOCF\\] data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable remitters) analysis set included all randomized participants who were in stable remission at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure (OM)."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '11.38', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '12.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full (stable responders) analysis set included all randomized participants who were stable responders (who were not stable remitters) at the end of the optimization phase and who received at least 1 dose of intranasal study drug and 1 dose of oral antidepressant during the maintenance phase.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '5.58', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '7.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "PHQ-9 is a 9-item, self-report scale assessing 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). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PHQ-9 Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '5.02', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '5.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "PHQ-9 is a 9-item, self-report scale assessing 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). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '4'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "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 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression-Severity Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '4'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "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 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Generalized Anxiety Disorder-7 Items (GAD-7) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '5.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Generalized Anxiety Disorder-7 Items Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '4.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Sum Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '11.87', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '14.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a Health Status Index (HSI). HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent\'s own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) \\*5. Higher score indicates worst health state.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of optimization phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.4', 'spread': '20.29', 'groupId': 'OG000'}, {'value': '-16.1', 'spread': '21.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.067', 'spread': '0.1180', 'groupId': 'OG000'}, {'value': '-0.096', 'spread': '0.1484', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol-5 Dimension-5 Level Sum Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '13.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent\'s own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) \\*5. Higher score indicates worst health state.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D-5L EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '15.55', 'groupId': 'OG000'}, {'value': '-13.8', 'spread': '19.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.023', 'spread': '0.0753', 'groupId': 'OG000'}, {'value': '-0.073', 'spread': '0.1383', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '7.34', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '10.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores \\<= 4 for each item and \\<= 12 for the total score are considered response. Scores \\<= 2 for each item and \\<= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sheehan Disability Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'OG001', 'title': 'Oral AD+ Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: Participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '6.63', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '7.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores \\<= 4 for each item and \\<= 12 for the total score are considered response. Scores \\<= 2 for each item and \\<= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intranasal Esketamine + Oral AD', 'description': 'Open-label induction (IND) phase (DE): received 56 or 84 milligram intranasal esketamine solution twice weekly with open-label oral AD (one of: duloxetine/escitalopram/sertraline/venlafaxine extended release \\[XR\\]), once daily for 4 weeks. OP phase (DE+TE): received intranasal esketamine (same dose) solution once per week for first 4 weeks, then once per week/once every other week based on severity of depressive symptoms, and continued same oral AD from IND phase for 12 weeks. MA phase (DE+TE): Participants were randomized (at end of OP phase) to receive intranasal esketamine (same dose) once weekly/once every other week based on depressive symptoms and continued same oral AD from IND phase. Follow-up (FU) phase: participants received no intranasal esketamine but continued oral AD for 2 weeks unless determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}, {'id': 'FG001', 'title': 'Oral AD + Intranasal Placebo', 'description': 'Open-label induction phase: No intervention was administered. Optimization phase (transferred-entry participants): received intranasal esketamine matching placebo solution once per week for the first 4 weeks, then once per week or once every other week depending on severity of depressive symptoms with open-label oral antidepressant (AD) (one of: duloxetine/escitalopram/sertraline/venlafaxine XR), once daily for 12 weeks. Maintenance (MA) phase (DE+TE participants): Participants were randomized (at the end of optimization phase) to receive intranasal esketamine placebo with oral AD from optimization phase. Follow-up Phase: participants received oral AD for 2 weeks of the follow-up phase unless it was determined to not be clinically appropriate. Participants who were non-responders at end of IND phase or who were early terminated at any phase proceeded directly to FU phase.'}], 'periods': [{'title': 'Induction Phase: DE Participants', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '437'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants who completed and met predefined response criteria continued to OP phase.', 'groupId': 'FG000', 'numSubjects': '273'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Not meet criteria to continue next phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Optimization Phase: DE+TE Participants', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Total participants: direct-entry (273) + esketamine-treated transferred-entry participants (182).', 'groupId': 'FG000', 'numSubjects': '455'}, {'comment': 'Placebo treated transferred-entry participant.', 'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants who completed and met predefined remission/response criteria randomized to MA phase', 'groupId': 'FG000', 'numSubjects': '297'}, {'comment': 'Participants who completed and met predefined remission/response criteria continued to MA phase.', 'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'MADRS >= 22 for 2 Consecutive Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Not meet criteria to continue next phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Maintenance Phase: DE+TE Participants', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '152 participants randomized from intranasal esketamine arm after OP phase: DE (90) + TE (62)', 'groupId': 'FG000', 'numSubjects': '152'}, {'comment': '145 participants randomized from intranasal esketamine arm after OP phase+54 continued from OP phase', 'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'Stable Remitters', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'Stable Responders', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}, {'title': 'Follow-up Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '481'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '470'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Total of 719 participants were enrolled out of which 705 were included in the analysis. 14 participants were excluded due to premature closure of a site due to quality and data integrity issues.', 'preAssignmentDetails': 'Out of 705 participants, 437 (direct entry \\[DE\\] participants) entered in induction (IND) phase and 268 participants (150 transferred-entry \\[TE\\] participants from study ESKETINTRD3001 \\[NCT02417064\\] and 118 participants from study ESKETINTRD3002 \\[NCT02418585\\]) entered in this study in optimization (OP) phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All Participants (direct entry and transferred entry) who were enrolled in this study and received intranasal esketamine, matching placebo and oral antidepressant as per the assigned treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.1', 'spread': '11.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '457', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '248', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '600', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': 'White Non-Hispanic', 'categories': [{'measurements': [{'value': '562', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'BRAZIL', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'CZECH REPUBLIC', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}]}]}, {'title': 'ESTONIA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'HUNGARY', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'MEXICO', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}]}]}, {'title': 'SLOVAKIA', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'SWEDEN', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'TURKEY', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '190', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline characteristics are reported for the all enrolled population. Not all participants enrolled were actually randomized to one of 2 treatments in the Maintenance phase as they had to meet specific criteria to be randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-04', 'size': 2642431, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-29T10:17', 'hasProtocol': True}, {'date': '2018-02-16', 'size': 3070276, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-03-29T10:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 719}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'dispFirstSubmitDate': '2019-02-12', 'completionDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2015-05-13', 'dispFirstSubmitQcDate': '2019-02-12', 'resultsFirstSubmitDate': '2019-03-29', 'studyFirstSubmitQcDate': '2015-07-07', 'dispFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-20', 'studyFirstPostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Relapse in Participants With Stable Remission (Maintenance Phase)', 'timeFrame': 'Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)', 'description': 'Relapse is defined as any of following: Montgomery-asberg depression rating scale (MADRS) total score greater than or equal to (\\>=) 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable remission: MADRS total score less than or equal to (\\<=) 12 for at least 3 of last 4 weeks of OP phase, with 1 excursion total score greater than (\\>) 12 or one missing assessment at OP week 13 or 14.'}], 'secondaryOutcomes': [{'measure': 'Time to Relapse in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'timeFrame': 'Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)', 'description': 'Relapse is defined as any of following: MADRS total score \\>= 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable response is defined as \\>= 50 percent (%) reduction in MADRS total score from baseline (Day 1 of induction phase, prior to first intranasal dose) in each of the last 2 weeks of the OP phase, but without meeting criteria for stable remission.'}, {'measure': 'Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (last observation carried forward \\[LOCF\\] data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.'}, {'measure': 'Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.'}, {'measure': 'Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "PHQ-9 is a 9-item, self-report scale assessing 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). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint."}, {'measure': 'Change From Baseline in PHQ-9 Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "PHQ-9 is a 9-item, self-report scale assessing 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). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint."}, {'measure': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "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 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint."}, {'measure': 'Change From Baseline in Clinical Global Impression-Severity Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "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 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint."}, {'measure': 'Change From Baseline in Generalized Anxiety Disorder-7 Items (GAD-7) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.'}, {'measure': 'Change From Baseline in Generalized Anxiety Disorder-7 Items Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.'}, {'measure': 'Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Sum Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a Health Status Index (HSI). HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent\'s own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) \\*5. Higher score indicates worst health state.'}, {'measure': 'Change From Baseline in EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine)."}, {'measure': 'Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health).'}, {'measure': 'Change From Baseline in EuroQol-5 Dimension-5 Level Sum Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent\'s own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) \\*5. Higher score indicates worst health state.'}, {'measure': 'Change From Baseline in EQ-5D-5L EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': "EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine)."}, {'measure': 'Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health).'}, {'measure': 'Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores \\<= 4 for each item and \\<= 12 for the total score are considered response. Scores \\<= 2 for each item and \\<= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.'}, {'measure': 'Change From Baseline in Sheehan Disability Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)', 'timeFrame': 'Baseline and Endpoint (Up to 92 Weeks)', 'description': 'The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores \\<= 4 for each item and \\<= 12 for the total score are considered response. Scores \\<= 2 for each item and \\<= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment-resistant Depression', 'Esketamine', 'Placebo', 'Oral Antidepressant', 'Relapse prevention'], 'conditions': ['Depressive Disorder, Treatment-Resistant']}, 'referencesModule': {'references': [{'pmid': '38557430', 'type': 'DERIVED', 'citation': 'Kern Sliwa J, Naranjo RR Jr, Turkoz I, Petrillo MP, Cabrera P, Trivedi M. Effects of esketamine nasal spray on depressive symptom severity in adults with treatment-resistant depression and associations between the Montgomery-Asberg Depression Rating Scale and the 9-item Patient Health Questionnaire. CNS Spectr. 2024 Jun;29(3):176-186. doi: 10.1017/S1092852924000105. Epub 2024 Apr 1.'}, {'pmid': '37558912', 'type': 'DERIVED', 'citation': 'Castro M, Wilkinson ST, Al Jurdi RK, Petrillo MP, Zaki N, Borentain S, Fu DJ, Turkoz I, Sun L, Brown B, Cabrera P. Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study. CNS Drugs. 2023 Aug;37(8):715-723. doi: 10.1007/s40263-023-01026-3. Epub 2023 Aug 9.'}, {'pmid': '36149841', 'type': 'DERIVED', 'citation': 'Williamson DJ, Gogate JP, Kern Sliwa JK, Manera LS, Preskorn SH, Winokur A, Starr HL, Daly EJ. Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression. J Clin Psychiatry. 2022 Sep 19;83(6):21m14318. doi: 10.4088/JCP.21m14318.'}, {'pmid': '35022754', 'type': 'DERIVED', 'citation': 'Chen G, Chen L, Zhang Y, Li X, Lane R, Lim P, Daly EJ, Furey ML, Fedgchin M, Popova V, Singh JB, Drevets WC. Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression. Int J Neuropsychopharmacol. 2022 Apr 19;25(4):269-279. doi: 10.1093/ijnp/pyab084.'}, {'pmid': '34235612', 'type': 'DERIVED', 'citation': 'Doty RL, Popova V, Wylie C, Fedgchin M, Daly E, Janik A, Ochs-Ross R, Lane R, Lim P, Cooper K, Melkote R, Jamieson C, Singh J, Drevets WC. Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. CNS Drugs. 2021 Jul;35(7):781-794. doi: 10.1007/s40263-021-00826-9. Epub 2021 Jul 7.'}, {'pmid': '32860422', 'type': 'DERIVED', 'citation': 'Katz EG, Hough D, Doherty T, Lane R, Singh J, Levitan B. Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression. Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 Oct 13.'}, {'pmid': '31166571', 'type': 'DERIVED', 'citation': 'Daly EJ, Trivedi MH, Janik A, Li H, Zhang Y, Li X, Lane R, Lim P, Duca AR, Hough D, Thase ME, Zajecka J, Winokur A, Divacka I, Fagiolini A, Cubala WJ, Bitter I, Blier P, Shelton RC, Molero P, Manji H, Drevets WC, Singh JB. Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Sep 1;76(9):893-903. doi: 10.1001/jamapsychiatry.2019.1189.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CR107128&attachmentIdentifier=d913e5fa-3636-4665-a11c-7b69d8a8df62&fileName=ESKETINTRD3003_(CR107128)_Additional_results_data_CH.pdf&versionIdentifier=', 'label': 'A Randomized, Double-blind, Multicenter, Active-controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.', 'detailedDescription': "This is a randomized, double-blind (neither the researchers nor the participant know what treatment the participants is receiving), active-controlled, multicenter (more than 1 study site) study in participants with TRD to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms. The study will consist of 5 phases: Screening/Prospective Observational Phase (4-7weeks) for direct-entry participants only, Open-label Induction Phase (4-weeks) for direct-entry participants only, Optimization Phase (12-weeks; open-label for direct-entry participants and double-blind for transferred-entry participants), Maintenance Phase (variable duration; double-blind for all participants) and Follow-up Phase (2-weeks). Participants' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor Direct-Entry Participants\n\n* At the time of signing the informed consent form (ICF), participant must be a man or woman 18 (or older if the minimum legal age of consent in the country in which the study is taking place is greater than \\[\\>\\]18) to 64 years of age, inclusive - At the start of the screening/prospective observational phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single-episode MDD, the duration must be greater than or equal to \\[\\>=\\] 2 years) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI)\n* At the start of the screening/prospective observational phase, participant must have an Inventory of Depressive Symptomatology-Clinician rated ( IDS-C30) total score of greater than or equal to (\\>=) 34\n* At the start of the screening/prospective observational phase, participants must have had nonresponse (less than or equal to 25 percent \\[%\\] improvement) to greater than or equal to (\\>=1) but less than or equal to (\\<=) 5 oral antidepressant treatments taken at adequate dosage and for adequate duration, as assessed using the Massachusetts General Hospital (MGH-ATRQ )\n* MGH-ATRQ and documented by medical history and pharmacy/prescription records, for the current episode of depression. In addition, the participant is taking different ongoing oral antidepressant treatment (on the MGH-ATRQ) for at least the previous 2 weeks at or above the minimal therapeutic dose\n* The participant's current major depressive episode, depression symptom severity (Week 1 MADRS total score \\>=28 required), and treatment response to antidepressant treatments used in the current depressive episode (retrospectively assessed) must be deemed valid for participation in a clinical study based on a Site-Independent Qualification Assessment For Transferred-Entry Participants\n* The participant must have completed the double-blind induction phase in ESKETINTRD3001 or ESKETINTRD3002 and must have demonstrated response at the end of that phase (\\>=50% reduction in the MADRS total score from baseline \\[Day 1 pre-randomization\\] at the end of the 4-week double-blind induction phase)\n\nExclusion Criteria:\n\n* Participants who have previously demonstrated nonresponse of depressive symptoms to esketamine or ketamine in the current major depressive episode, to all 4 of the oral antidepressant treatment options available for the double-blind induction phase (ie, duloxetine, escitalopram, sertraline, and venlafaxine extended release \\[XR\\]) in the current major depressive episode (based on MGH-ATRQ), or an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT\n* Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression\n* Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the MINI), obsessive compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder\n* Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening/prospective observational phase, per the investigator's clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS)\n* Participants with history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria"}, 'identificationModule': {'nctId': 'NCT02493868', 'acronym': 'SUSTAIN-1', 'briefTitle': 'A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression', 'orgStudyIdInfo': {'id': 'CR107128'}, 'secondaryIdInfos': [{'id': 'ESKETINTRD3003', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2014-004586-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal Esketamine plus oral antidepressant', 'description': 'Open-Label Induction Phase: Direct-entry participants will self-administer esketamine intranasally twice per week for 4 weeks as a flexible dose regimen in the Open-label Induction Phase. Participants will initiate a new oral antidepressant on Day 1 of this phase. Optimization Phase: Direct-entry and transferred-entry participants will self-administer intranasal esketamine (same dose) at weekly treatment sessions for the first 4 weeks of this phase, then individualized to either once weekly or once every other week based on depressive symptoms. Participants continue same oral antidepressant treatment from induction phase. Maintenance Phase: Direct-entry and transferred-entry participants assigned to esketamine will self-administer intranasal esketamine (same dose) once weekly or once every other week based on depressive symptoms. Participants continue same oral antidepressant treatment from induction phase.', 'interventionNames': ['Drug: Esketamine', 'Drug: Duloxetine (Oral Antidepressant)', 'Drug: Escitalopram (Oral antidepressant)', 'Drug: Sertraline (Oral Antidepressant)', 'Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo Plus Oral Antidepressant', 'description': 'Optimization Phase: Transferred-entry participants will self-administer intranasal placebo at weekly treatment sessions for the first 4 weeks of this phase, then individualized to either once weekly or once every other week based on depressive symptoms. Participants continue same oral antidepressant treatment from induction phase. Maintenance Phase: Direct-entry and transferred-entry participants assigned to intranasal placebo will self-administer intranasal placebo once weekly or once every other week based on depressive symptoms. Participants continue same oral antidepressant treatment from induction phase.', 'interventionNames': ['Drug: Placebo', 'Drug: Duloxetine (Oral Antidepressant)', 'Drug: Escitalopram (Oral antidepressant)', 'Drug: Sertraline (Oral Antidepressant)', 'Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant)']}], 'interventions': [{'name': 'Esketamine', 'type': 'DRUG', 'description': "Open-label induction phase: Direct entry participants start at a dose of 56 mg on Day 1. On Day 4, the dose may be increased to 84 mg or remain at 56 mg. From Day 8 to 22, dose may be increased to 84 mg, remain the same or be reduced to 56 mg from 84 mg per protocol, at investigator's discretion based on efficacy and/or tolerability. On Day 25, a dose reduction from 84 mg to 56 mg is permitted but no dose increase is permitted. Optimization Phase: Direct-entry and transferred-entry participants will self-administer intranasal esketamine (same dose) for first 4 weeks, then individualized to either once weekly or once every other week based on depressive symptoms. Maintenance Phase: All participants assigned to esketamine will self-administer intranasal esketamine once weekly or once every other week based on depressive symptoms.", 'armGroupLabels': ['Intranasal Esketamine plus oral antidepressant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Optimization Phase: Transferred-entry participant will self-administer intranasal placebo at weekly treatment sessions for the first 4 weeks of this phase, then individualized to either once weekly or once every other week based on depressive symptoms. Maintenance Phase: Direct-entry and transferred-entry participants assigned to placebo will self-administer matching intranasal placebo once weekly or once based on depressive symptoms.', 'armGroupLabels': ['Placebo Plus Oral Antidepressant']}, {'name': 'Duloxetine (Oral Antidepressant)', 'type': 'DRUG', 'description': 'Duloxetine could be selected as the oral antidepressant medication by the investigator based on review of Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and relevant prior antidepressant medication information. The minimum therapeutic dose is 60 milligram per day (mg/day).', 'armGroupLabels': ['Intranasal Esketamine plus oral antidepressant', 'Placebo Plus Oral Antidepressant']}, {'name': 'Escitalopram (Oral antidepressant)', 'type': 'DRUG', 'description': 'Escitalopram could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Escitalopram will be titrated upto a maximum dose of 20 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 10 mg/day.', 'armGroupLabels': ['Intranasal Esketamine plus oral antidepressant', 'Placebo Plus Oral Antidepressant']}, {'name': 'Sertraline (Oral Antidepressant)', 'type': 'DRUG', 'description': 'Sertraline could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Sertraline will be titrated upto a maximum dose of 200 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 50 mg/day.', 'armGroupLabels': ['Intranasal Esketamine plus oral antidepressant', 'Placebo Plus Oral Antidepressant']}, {'name': 'Venlafaxine Extended Release (XR) (Oral Antidepressant)', 'type': 'DRUG', 'description': 'Venlafaxine Extended Release could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Venlafaxine Extended Release will be titrated upto a maximum dose of 225 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 150 mg/day.', 'armGroupLabels': ['Intranasal Esketamine plus oral antidepressant', 'Placebo Plus Oral Antidepressant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'city': 'Oakland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Marcos', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.14337, 'lon': -117.16614}}, {'city': 'San Rafael', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.97353, 'lon': -122.53109}}, {'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 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