Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-04-03 @ 6:56 PM
Study NCT ID:
NCT02782104
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2016-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy', 'Romania']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Global Medical Head', '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': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).', 'otherNumAtRisk': 458, 'deathsNumAtRisk': 458, 'otherNumAffected': 318, 'seriousNumAtRisk': 458, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 were received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability.", 'otherNumAtRisk': 1110, 'deathsNumAtRisk': 1110, 'otherNumAffected': 1010, 'seriousNumAtRisk': 1110, 'deathsNumAffected': 8, 'seriousNumAffected': 212}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 198}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 58}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 116}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 80}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 59}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 184}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypoaesthesia Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 83}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 356}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Paraesthesia Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 69}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 176}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 145}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Feeling Drunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 84}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 71}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 134}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 72}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 133}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 267}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 74}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 142}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 176}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 71}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 157}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 182}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 226}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 84}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 79}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 365}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Dizziness Postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 57}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 217}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 401}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 102}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 56}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 92}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 84}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 253}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 197}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 73}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Dissociation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 272}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 149}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 114}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Nasal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 93}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 95}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 65}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 60}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 79}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Myocardial Bridging', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vertigo Positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Duodenal Perforation', 'stats': [{'groupId': 'EG000', 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disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Large Intestine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Lower 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{'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Breast Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cervical Dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Epididymal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Heavy Menstrual Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vaginal Prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Bronchitis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Dyspnoea Exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Lung Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Nasal Polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Nasal Septum Deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pneumothorax Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Sleep Apnoea Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Tonsillar Hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vocal Cord Thickening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Abdominoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Female Sterilisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Mammoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Spinal Fusion Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Aortic Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Circulatory Collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypertensive Emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Peripheral Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 458, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1110, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '1085', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0218', 'spread': '0.10516', 'groupId': 'OG000'}, {'value': '-0.0065', 'spread': '0.13526', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. The DET is a measure of psychomotor function and uses a well-validated simple reaction time. In this outcome measure, speed of performance of subjects (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Total score ranged from 2 to 3.3 log 10 milliseconds (msec). Lower score indicated better performance. Higher change from baseline indicated better performance.', 'unitOfMeasure': 'log10 msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '1084', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0074', 'spread': '0.07819', 'groupId': 'OG000'}, {'value': '-0.0185', 'spread': '0.09893', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. IDN test is a measure of visual attention (choice reaction time) and scored for speed of response (mean of the log10 transformed reaction times for correct responses). Total score ranged from 2 to 3.3 log 10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance.', 'unitOfMeasure': 'log10 msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '1084', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0170', 'spread': '0.12356', 'groupId': 'OG000'}, {'value': '0.0397', 'spread': '0.15364', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. OCL test is a measure of visual episodic memory and visual recall test scored using arcsine transformation of the percentage of correct responses (CR). The range for OCL is 0 to 100 percent (%) accuracy; presented as an arcsin transformation, the range is 0 to 1.57. Higher score indicated better performance. Higher change from baseline indicated better performance.', 'unitOfMeasure': 'Arcsine (sqrt of percentage of CR)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '1084', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 were received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0086', 'spread': '0.08096', 'groupId': 'OG000'}, {'value': '0.0198', 'spread': '0.10329', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'The ONB is a measure of working memory and scored for speed of correct response (mean of the log10-transformed reaction times for correct responses). Total score ranged from 2 to 3.54 log10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance.', 'unitOfMeasure': 'log10 msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '1072', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '17.80', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '22.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. GMLT measures executive function; maze/sequencing test, scored for total number of errors. Total score ranged from 0 to 999 number of errors. Lower score indicated better performance. Higher change from baseline indicated better performance.', 'unitOfMeasure': 'Number of Errors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Change From Study Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '1091', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'title': 'Total Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '1091', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '5.05', 'groupId': 'OG001'}]}]}, {'title': 'Delayed Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '1091', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.81', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.03', 'groupId': 'OG001'}]}]}, {'title': 'Total Number of True Positives', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '1091', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '2.70', 'groupId': 'OG001'}]}]}, {'title': 'Recognition Discrimination Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '1091', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'The HVLT-R measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0-12); the total number of true-positive errors (0-12); and the range of recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher total recall score indicated higher cognition. The range of the recognition discrimination index is -12 to 12. Higher score indicated better performance and higher change from baseline indicated better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '1109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'title': 'Baseline: No Event', 'categories': [{'measurements': [{'value': '79.8', 'groupId': 'OG000'}, {'value': '94.8', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Suicidal ideation', 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Suicidal behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Most Severe Post Baseline: No Event', 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000'}, {'value': '70.2', 'groupId': 'OG001'}]}]}, {'title': 'Most Severe Post Baseline: Suicidal ideation', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}, {'value': '27.8', 'groupId': 'OG001'}]}]}, {'title': 'Most Severe Post Baseline: Suicidal behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and behavior, to assess whether participant experienced any of following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Here, percentage of participants with \\>=1 positive behavior, participants with \\>=1 positive ideations; no event were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}, {'value': '1110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '346', 'groupId': 'OG000'}, {'value': '1052', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'IND Phase: up to 4 weeks; OP/MA Phase: up to 78 months', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention up to end of study was considered as treatment-emergent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}, {'value': '1110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 were received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '9.52', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '10.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline (predose) in heart rate were reported.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included participants who received at least 1 dose of intranasal study medication in this study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Systolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}, {'value': '1110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '0.4', 'spread': '10.72', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '12.68', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '0.3', 'spread': '7.47', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '8.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline in systolic and diastolic blood pressure were reported.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included participants who received at least 1 dose of intranasal study medication in this study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}, {'value': '1110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline in respiratory rate were reported.', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included participants who received at least 1 dose of intranasal study medication in this study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Blood Oxygen Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}, {'value': '1110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline in blood oxygen saturation (predose) were reported.', 'unitOfMeasure': 'percentage of SpO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included participants who received at least 1 dose of intranasal study medication in this study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '1110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '-12.8', 'spread': '9.73', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '9.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'MADRS measures depression severity, detects changes due to AD treatment. It consists of 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe conditions. Negative change in score indicates improvement. Missing data was imputed using last observation carried forward (LOCF) method.', 'unitOfMeasure': 'score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'OG000'}, {'value': '1109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'spread': '5.84', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '6.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': "Change from baseline in PHQ-9 total score were reported. The PHQ-9 was a 9-item, patient-reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders. Each item was rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses were summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression-severity (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '1110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': "Change from baseline in clinical global impression-severity (CGI-S) score were reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative change in score indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sheehan Disability Scale (SDS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '1067', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '-6.4', 'spread': '7.13', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '8.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline in SDS total score were reported. The SDS, a patient-reported outcome measure, was a 5 item questionnaire which had been widely used and accepted for assessment of functional and associated disability impairment. The first three items assessed disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items were summed to create a total score of 0-30 where a higher score indicated greater impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant-Reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Valuation Index Score (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}, {'value': '1110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '18.05', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '18.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': "Change from baseline in participant-reported health-related quality of life as assessed by EQ-5D-5L VAS was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline as Assessed by EQ 5D-5L: Sum Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}, {'value': '1110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 were received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '-10.4', 'spread': '12.81', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '15.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', '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". 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': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant- Reported Health Related Quality of Life Using the Quality of Life in Depression Scale (QLDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '537', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray (IND Phase)', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years).'}, {'id': 'OG001', 'title': 'Esketamine Nasal Spray (OP/MA Phase)', 'description': "Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability."}], 'classes': [{'categories': [{'measurements': [{'value': '-8.2', 'spread': '8.47', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '9.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline in participant- reported health related quality of life using the QLDS. The QLDS is a disease-specific validated patient-reported outcome (PRO) measure which assesses the impact that depression has on a participant\'s quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of "1" or "0". A score of "1" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esketamine Nasal Spray', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years). Participants who entered the optimization and maintenance phase (OP/MA) from the IND phase of study NCT02782104 continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or ESKETINTRD3006 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered from study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in OP/MP.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1148'}]}, {'type': 'IND Phase', 'comment': 'Participants From Study NCT02417064:132; NCT02418585: 51; NCT02493868: 245; NCT02497287: 12; NCT02422186: 3; ESKETINTRD3006: 15', 'achievements': [{'groupId': 'FG000', 'numSubjects': '458'}]}, {'type': 'OP/MA Phase', 'comment': '690 Participants From Study (NCT02417064:0; NCT02418585: 0; NCT02493868: 224; NCT02497287: 455; NCT02422186: 1; ESKETINTRD3006: 10) and 420 Participants from IND Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '680'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '468'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '215'}]}, {'type': 'Induction Day 28 Non Responder', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1148', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Esketamine Nasal Spray', 'description': 'Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \\[mg\\] or 84 mg for participants less than \\[\\<\\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \\[\\>=\\] 65 years). Participants who entered the optimization and maintenance phase (OP/MA) from the IND phase of study NCT02782104 continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or ESKETINTRD3006 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered from study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in OP/MP.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.6', 'spread': '12.28', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '764', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '384', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '200', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '922', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '996', 'groupId': 'BG000'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'ARGENTINA', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}, {'title': 'AUSTRALIA', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'AUSTRIA', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'BRAZIL', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}, {'title': 'BULGARIA', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'CZECH REPUBLIC', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}]}]}, {'title': 'ESTONIA', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'FINLAND', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'HUNGARY', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'LITHUANIA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'MALAYSIA', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'MEXICO', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}, {'title': 'SLOVAKIA', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'SOUTH AFRICA', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'SOUTH KOREA', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}, {'title': 'SWEDEN', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}, {'title': 'TAIWAN', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'TURKEY', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'UNITED KINGDOM', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '328', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-05', 'size': 3386840, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-29T02:44', 'hasProtocol': True}, {'date': '2023-02-14', 'size': 1908312, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-29T02:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2016-04-29', 'resultsFirstSubmitDate': '2023-12-29', 'studyFirstSubmitQcDate': '2016-05-20', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-16', 'studyFirstPostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. The DET is a measure of psychomotor function and uses a well-validated simple reaction time. In this outcome measure, speed of performance of subjects (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Total score ranged from 2 to 3.3 log 10 milliseconds (msec). Lower score indicated better performance. Higher change from baseline indicated better performance.'}, {'measure': 'Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. IDN test is a measure of visual attention (choice reaction time) and scored for speed of response (mean of the log10 transformed reaction times for correct responses). Total score ranged from 2 to 3.3 log 10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance.'}, {'measure': 'Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. OCL test is a measure of visual episodic memory and visual recall test scored using arcsine transformation of the percentage of correct responses (CR). The range for OCL is 0 to 100 percent (%) accuracy; presented as an arcsin transformation, the range is 0 to 1.57. Higher score indicated better performance. Higher change from baseline indicated better performance.'}, {'measure': 'Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'The ONB is a measure of working memory and scored for speed of correct response (mean of the log10-transformed reaction times for correct responses). Total score ranged from 2 to 3.54 log10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance.'}, {'measure': 'Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. GMLT measures executive function; maze/sequencing test, scored for total number of errors. Total score ranged from 0 to 999 number of errors. Lower score indicated better performance. Higher change from baseline indicated better performance.'}, {'measure': 'Change From Study Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'The HVLT-R measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0-12); the total number of true-positive errors (0-12); and the range of recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher total recall score indicated higher cognition. The range of the recognition discrimination index is -12 to 12. Higher score indicated better performance and higher change from baseline indicated better performance.'}, {'measure': 'Percentage of Participants Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and behavior, to assess whether participant experienced any of following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Here, percentage of participants with \\>=1 positive behavior, participants with \\>=1 positive ideations; no event were reported.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'IND Phase: up to 4 weeks; OP/MA Phase: up to 78 months', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention up to end of study was considered as treatment-emergent.'}, {'measure': 'Change From Baseline in Heart Rate', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline (predose) in heart rate were reported.'}, {'measure': 'Change From Baseline in Systolic and Diastolic Blood Pressure', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline in systolic and diastolic blood pressure were reported.'}, {'measure': 'Change From Baseline in Respiratory Rate', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline in respiratory rate were reported.'}, {'measure': 'Change From Baseline in Blood Oxygen Saturation', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline in blood oxygen saturation (predose) were reported.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'MADRS measures depression severity, detects changes due to AD treatment. It consists of 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe conditions. Negative change in score indicates improvement. Missing data was imputed using last observation carried forward (LOCF) method.'}, {'measure': 'Change From Baseline in Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': "Change from baseline in PHQ-9 total score were reported. The PHQ-9 was a 9-item, patient-reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders. Each item was rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses were summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms."}, {'measure': 'Change From Baseline in Clinical Global Impression-severity (CGI-S) Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': "Change from baseline in clinical global impression-severity (CGI-S) score were reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative change in score indicates improvement."}, {'measure': 'Change From Baseline in Sheehan Disability Scale (SDS) Total Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline in SDS total score were reported. The SDS, a patient-reported outcome measure, was a 5 item questionnaire which had been widely used and accepted for assessment of functional and associated disability impairment. The first three items assessed disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items were summed to create a total score of 0-30 where a higher score indicated greater impairment.'}, {'measure': 'Change From Baseline in Participant-Reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Valuation Index Score (VAS)', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': "Change from baseline in participant-reported health-related quality of life as assessed by EQ-5D-5L VAS was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement."}, {'measure': 'Change From Baseline as Assessed by EQ 5D-5L: Sum Score', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', '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". 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 Participant- Reported Health Related Quality of Life Using the Quality of Life in Depression Scale (QLDS)', 'timeFrame': 'IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months', 'description': 'Change from baseline in participant- reported health related quality of life using the QLDS. The QLDS is a disease-specific validated patient-reported outcome (PRO) measure which assesses the impact that depression has on a participant\'s quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of "1" or "0". A score of "1" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depressive Disorder, Treatment-Resistant', 'Esketamine', 'JNJ-54135419'], 'conditions': ['Depressive Disorder, Treatment-Resistant']}, 'referencesModule': {'references': [{'pmid': '40319349', 'type': 'DERIVED', 'citation': 'Zaki N, Chen LN, Lane R, Doherty T, Drevets WC, Morrison RL, Sanacora G, Wilkinson ST, Young AH, Lacerda ALT, Paik JW, Popova V, Fu DJ. Safety and efficacy with esketamine in treatment-resistant depression: long-term extension study. Int J Neuropsychopharmacol. 2025 Jun 6;28(6):pyaf027. doi: 10.1093/ijnp/pyaf027.'}, {'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': '37173512', 'type': 'DERIVED', 'citation': 'Zaki N, Chen LN, Lane R, Doherty T, Drevets WC, Morrison RL, Sanacora G, Wilkinson ST, Popova V, Fu DJ. Long-term safety and maintenance of response with esketamine nasal spray in participants with treatment-resistant depression: interim results of the SUSTAIN-3 study. Neuropsychopharmacology. 2023 Jul;48(8):1225-1233. doi: 10.1038/s41386-023-01577-5. Epub 2023 May 12.'}, {'pmid': '32818917', 'type': 'DERIVED', 'citation': 'Starr HL, Abell J, Larish A, Lewis S, DeMuro C, Gogate J, Jamieson C, Daly E, Zaki N, Kramer M. Self-reported review of the value of esketamine in patients with treatment-resistant depression: Understanding the patient experience in the STRIVE Study. Psychiatry Res. 2020 Nov;293:113376. doi: 10.1016/j.psychres.2020.113376. Epub 2020 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).', 'detailedDescription': 'This is an open-label (the researchers and participants know the treatment the participant is receiving) long-term extension study. The study will consist of 2 open-label Phases: 4-week Induction phase (if applicable) and Open-Label Optimization/Maintenance phase (variable). Participants will enter the study Induction Phase from ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3005 (NCT02422186) and ESKETINTRD3006 (US sites only). Participants will enter the study Open-Label Optimization/Maintenance phase from ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868) (if appropriate at week 16) or ESKETINTRD3006 (US sites only). In the Open-Label Induction Phase, participants will self-administer flexibly-dosed esketamine nasal spray. During first 4 weeks in Optimization/Maintenance Phase responder participants from the induction phase of study 54135419TRD3008, will continue on the same dose of esketamine nasal spray from the induction phase and have a weekly intranasal treatment session frequency. Participants entering the optimization/maintenance phase from study ESKETINTRD3005 will also have a weekly intranasal treatment session frequency. However, as the ESKETINTRD3005 intranasal study medication is blinded at the time of entry into the current study, the dose of esketamine nasal spray will be administered as outlined in protocol. Participants entering the optimization/maintenance phase from study ESKETINTRD3003 (Direct Entry) or ESKETINTRD3004 who were ongoing in the Optimization, Maintenance, or Optimization/Maintenance phase, respectively, will have the option to have their current intranasal dosing frequency adjusted at the time of entry into 54135419TRD3008 study and should remain on the selected frequency from week 1 to week 4. A one-time dose change will be permitted at study entry. After 4 weeks, esketamine nasal spray treatment sessions will be individualized to either once weekly or once every other week at the fixed 2-week interval (based on clinical global impression - severity \\[CGI-S\\] performed at that visit), and every 4 weeks for participants dosed at the 4 week interval. Participants safety will be monitored throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Based on the prior study the participant is entering 54135419TRD3008 from: a) From ESKETINTRD3001 (NCT02417064) or ESKETINTRD3002 (NCT02418585) study: Participant has completed the induction phase and the 2-weeks follow up phase visit; or Participants completed the induction phase and was a responder and study ESKETINTRD3003 is terminated.; b) From ESKETINTRD3003 (NCT02493868) study: (1) Participant relapsed during the maintenance phase; or (2) Participant was in the induction phase of the ESKETINTRD3003 study when the study was terminated and, after completion of the induction phase, was determined to be a responder; or (3) Participant was in the optimization or maintenance phases at the time the study was terminated; or (4) or (5) Participants was in the induction phase and after completion of induction phase was determined to not meet response criteria (1) Participant completed ESKETINTRD3004 study (optimization/maintenance phase); or (2) Participant was in the induction phase of the ESKETINTRD3004 study when the study was terminated and, after completion of the induction phase, was determined to be a responder; or (3) Participant was in the optimization/maintenance phase at the time the study was terminated; (4) Participant was in the induction phase and did not meet criteria for response may be eligible for to be rolled over into 54135419TRD3008. d) From ESKETINTRD3005 (NCT02422186) study: Participant was in the induction phase of the ESKETINTRD3005 study at the time enrollment into the ESKETINTRD3004 study was closed and, after completion of the induction phase, was determined to be a responder or did not meet the criteria for response. e) From ESKETINTRD3006 study (US Study sites only) (1) Participant completed the induction phase and was a responder.\n* Participant must be medically stable on the basis of physical examination, vital signs, pulse oximetry, and 12-lead Electrocardiogram (ECG) performed predose on the day of the first intranasal treatment session. If there are any abnormalities that are not specified in the inclusion and exclusion criteria, their clinical significance must be determined by the investigator and recorded in the participant\'s source documents and initialed by the investigator\n* Participant must be medically stable according to the investigator\'s judgment and knowledge of the subject\'s medical stability in the parent study. This determination must be documented.\n* A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \\[b-hCG\\]) predose on the day of the first intranasal treatment session\n* During the study (that is, from the first intranasal treatment session) and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of intranasal study medication, a man who is sexually active with a woman of childbearing potential must be practicing a highly effective method of contraception with his female partner c) must agree not to donate sperm.\n\nExclusion Criteria:\n\n* The evaluation of the benefit versus risk of continued esketamine nasal spray treatment is not favorable for the participant in the opinion of the investigator\n* Since the last study visit in the participant\'s prior study, participant has suicidal ideation with intent to act per the investigator\'s clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS) \\[corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) in the suicidal ideation module of the C-SSRS\\] or suicidal behavior per the investigator\'s clinical judgment or based on the C-SSRS (corresponding to any score higher than 0 in the suicidal behavior module of the C-SSRS)\n* Participant has positive test result(s) for drugs of abuse (including barbiturates, methadone, opiates, cocaine, phencyclidine, and amphetamine/methamphetamine) predose on the day of the first intranasal treatment session\n* Participant has any anatomical or medical condition that, per the investigator\'s clinical judgment based on assessment, may impede delivery or absorption of intranasal study drug\n* Participant has taken any prohibited therapies that would not permit administration of the first intranasal treatment session'}, 'identificationModule': {'nctId': 'NCT02782104', 'acronym': 'SUSTAIN-3', 'briefTitle': 'A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'An Open-label Long-term Extension Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression', 'orgStudyIdInfo': {'id': 'CR108149'}, 'secondaryIdInfos': [{'id': '54135419TRD3008', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2015-003578-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esketamine Nasal Spray', 'description': "Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram \\[mg\\] or 84 mg for those \\< 65 years; 28 mg, 56 mg or 84 mg for those \\>= 65 years). Participants \\>= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3004 (NCT02497287), or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.", 'interventionNames': ['Drug: Esketamine Nasal Spray']}], 'interventions': [{'name': 'Esketamine Nasal Spray', 'type': 'DRUG', 'otherNames': ['JNJ-54135419'], 'description': "Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram \\[mg\\] or 84 mg for those \\< 65 years; 28 mg, 56 mg or 84 mg for those \\>= 65 years). Participants \\>= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585) or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.", 'armGroupLabels': ['Esketamine Nasal Spray']}]}, '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': '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': 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'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Gaithersburg', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.14344, 'lon': -77.20137}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'city': 'Rochester Hills', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.65837, 'lon': -83.14993}}, {'city': "O'Fallon", 'state': 'Missouri', 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