Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
Study NCT ID:
NCT01051466
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2010-01-15
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of the Neurobiology of Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Three healthy participants were identified as not meeting inclusion/exclusion criteria after enrollment. They were discontinued and excluded from secondary outcome analyses, but included in participant flow, primary outcome analyses, and safety.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD) received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose.', 'otherNumAtRisk': 32, 'otherNumAffected': 32, 'seriousNumAtRisk': 32, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.', 'otherNumAtRisk': 28, 'otherNumAffected': 11, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sluggishness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Allergy to animal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Procedural dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastric ph decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Food craving', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Joint stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myoclonus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'White matter lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anorgasmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Obsessive-compulsive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Micturition disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary hesitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ejaculation delayed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ejaculation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Yawning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Retinal pigment epitheliopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to 12-Week Endpoint in the Functional Magnetic Resonance Imaging (fMRI) Mean Blood Oxygenation-Level-Dependent (BOLD) Response in the Amygdalae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.457', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The significance level was 0.05 for a 2-sided test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Functional MRI or fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces was measured by the percentage of signal change in BOLD response from before to after sad faces processing. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Amygdala BOLD activation was calculated as an average between the left amygdala activation and right amygdala activation. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.', 'unitOfMeasure': 'percentage of signal change', 'dispersionType': 'Standard Error', 'populationDescription': 'Enrolled participants who had baseline and at least 1 post-baseline activation (BOLD response) observation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week Endpoint in Activation [Blood Oxygenation-Level-Dependent (BOLD) Response to Implicit Processing of Sad Faces] for Each of the 3 Brain Regions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'classes': [{'title': 'Anterior Cingulate', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Left Amygdala', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Right Amygdala', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.627', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline activation (BOLD response) in the anterior cingulate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.338', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline activation (BOLD response) in the left amygdala.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.518', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline activation (BOLD response) in the right amygdala.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Functional magnetic resonance imaging (fMRI) is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces in each brain region (anterior cingulate, left amygdala and right amygdala) was measured by the percentage of signal change in BOLD response. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.', 'unitOfMeasure': 'percentage of signal change', 'dispersionType': 'Standard Error', 'populationDescription': 'Enrolled participants who had baseline and at least 1 post-baseline activation (BOLD response) observation, excluding 3 healthy participants who did not meet entry criteria.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week Endpoint in Volume of Subgenual Anterior Cingulate, Amygdalae, and Hippocampus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'classes': [{'title': 'Subgenual Anterior Cingulate', 'categories': [{'measurements': [{'value': '-188.27', 'spread': '112.37', 'groupId': 'OG000'}, {'value': '175.22', 'spread': '116.14', 'groupId': 'OG001'}]}]}, {'title': 'Left Amygdalae', 'categories': [{'measurements': [{'value': '-23.68', 'spread': '15.25', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '15.59', 'groupId': 'OG001'}]}]}, {'title': 'Right Amygdalae', 'categories': [{'measurements': [{'value': '-33.38', 'spread': '17.83', 'groupId': 'OG000'}, {'value': '23.86', 'spread': '18.40', 'groupId': 'OG001'}]}]}, {'title': 'Left Hippocampus', 'categories': [{'measurements': [{'value': '-13.56', 'spread': '23.53', 'groupId': 'OG000'}, {'value': '18.52', 'spread': '24.37', 'groupId': 'OG001'}]}]}, {'title': 'Right Hippocampus', 'categories': [{'measurements': [{'value': '-14.70', 'spread': '19.19', 'groupId': 'OG000'}, {'value': '21.80', 'spread': '19.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline volume in the subgenual anterior cingulate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.208', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline volume in the left amygdalae.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline volume in the right amygdalae.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.350', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline volume in the left hippocampus.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.191', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline volume in the right hippocampus.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The volume of specific brain regions is obtained using a structural magnetic resonance imaging (sMRI) procedure in which high-resolution spoiled gradient recall images are acquired in coronal brain slices. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.', 'unitOfMeasure': 'cubic millimeters (mm^3)', 'dispersionType': 'Standard Error', 'populationDescription': 'Enrolled participants who had baseline and at least 1 post-baseline observation for the volume of specific brain regions, excluding 3 healthy participants who did not meet entry criteria.'}, {'type': 'SECONDARY', 'title': 'Translocation of Gs Alpha (Gsα) From Lipid Rafts in the Cell Membranes of Red Blood Cells (RBCs), White Blood Cells (WBCs) and Platelets Compared With Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'classes': [{'title': 'RBCs, Week 1 (n=23, 22)', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'RBCs, Week 8 (n=23, 22)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'RBCs, Week 12 (n=23, 22)', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Week 1 (n=23, 20)', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Week 8 (n=23, 20)', 'categories': [{'measurements': [{'value': '-1.16', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Week 12 (n=23, 20)', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '5.40', 'groupId': 'OG000'}, {'value': '7.93', 'spread': '5.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.174', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for Gsα translocation in RBCs at Week 1.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.488', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for Gsα translocation in RBCs at Week 8.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.480', 'groupIds': ['OG001'], 'pValueComment': 'The p-value is for Gsα translocation in RBCs at Week 12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.925', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for Gsα translocation in platelets at Week 1.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.697', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for Gsα translocation in platelets at Week 8.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.276', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for Gsα translocation in platelets at Week 12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1, 8, and 12', 'description': 'Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Gsα localization in the cholesterol-rich (lipid rafts) and cholesterol-poor regions of cell membranes of RBCs and platelets was measured with quantitative Western blots and reported as the ratio of Gsα (absorbance units) in Triton X-100 (TX-100) over Triton X-114 (TX-114), 2 detergents that discriminate between lipid raft and non-raft membrane domains. Translocation of Gsα was measured as the change from baseline in Gsα localization. Translocation of Gsα from lipid rafts in the cell membranes of WBCs was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'populationDescription': 'Enrolled participants who had a baseline and at least 1 post-baseline Gsα localization observation, excluding 3 healthy participants who did not meet entry criteria. No participants were analyzed for the translocation of Gsα from lipid rafts in the cell membranes of WBCs.'}, {'type': 'SECONDARY', 'title': 'Gs Alpha (Gsα)-Activated Adenylyl Cyclase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'timeFrame': 'Baseline and Weeks 1, 8, and 12', 'description': 'Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Adenylyl cyclase is activated by Gsα, and when Gsα is translocated from lipid rafts it more effectively activates adenylyl cyclase. Gsα-activated adenylyl cyclase was not analyzed due to technical laboratory issues.', 'populationDescription': 'No participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'classes': [{'title': 'BDNF (n=23, 21)', 'categories': [{'measurements': [{'value': '6.61', 'spread': '23.38', 'groupId': 'OG000'}, {'value': '10.57', 'spread': '22.80', 'groupId': 'OG001'}]}]}, {'title': 'proBDNF (n=13, 17)', 'categories': [{'measurements': [{'value': '-5.67', 'spread': '12.77', 'groupId': 'OG000'}, {'value': '-9.37', 'spread': '9.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.904', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline BDNF.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.819', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline proBDNF.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Error', 'populationDescription': 'Enrolled participants who had baseline and at least 1 post-baseline BDNF or proBDNF observation, excluding 3 healthy participants who did not meet entry criteria.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF) Receptors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.1', 'spread': '41.08', 'groupId': 'OG000'}, {'value': '-8.9', 'spread': '36.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.273', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline trkB.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Tropomyosin receptor kinase B (trkB) is a receptor for BDNF, and pan-neurotrophin receptor p75 (p75NTR) is a receptor for proBDNF. p75NTR was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.', 'unitOfMeasure': 'picograms per milligram (pg/mg)', 'dispersionType': 'Standard Error', 'populationDescription': 'Enrolled participants who had baseline and at least 1 post-baseline trkB observation, excluding 3 healthy participants who did not meet entry criteria. No participant was analyzed for the change from baseline in p75NTR receptors.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week Endpoint in Proinflammatory Cytokines [Tumor Necrosis Factor Alpha (TNFα), Interleukin 1 (IL-1), and Interleukin 6 (IL-6)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'classes': [{'title': 'Cytokine TNFα', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Cytokine IL-1', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '4.01', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': 'Cytokine IL-6', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.797', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline cytokine TNFα.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.269', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline cytokine IL-1.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.925', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value is for change from baseline cytokine IL-6.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Cytokines are naturally produced and regulate responses to inflammation. Proinflammatory cytokines like TNFα, IL-1, and IL-6 increase inflammation in the body. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.', 'unitOfMeasure': 'picograms per milliliter (pg/mL)', 'dispersionType': 'Standard Error', 'populationDescription': 'Enrolled participants who had baseline and at least 1 post-baseline cytokine observation (TNFα, IL-1, or IL-6), excluding 3 healthy participants who did not meet entry criteria.'}, {'type': 'SECONDARY', 'title': '17-Item Hamilton Depression Rating Scale (HAMD17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.4', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '8.5', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to Week 12', 'description': 'The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Enrolled participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, up to Week 12', 'description': 'HAMD17 response is defined as a \\>50% reduction in HAMD17 total score from baseline. The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with a HAMD17 response was calculated as the number of participants with a \\>50% reduction in HAMD17 total score from baseline divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'populationDescription': 'Enrolled MDD participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, up to Week 12', 'description': 'HAMD17 remission is defined as a HAMD17 total score of ≤7 at Week 12 (endpoint). The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with remission was calculated as the number of participants with a HAMD17 total score of ≤7 divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'populationDescription': 'Enrolled MDD participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.'}, {'type': 'SECONDARY', 'title': 'Sheehan Disability Scale (SDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '19.3', 'spread': '5.41', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '9.4', 'spread': '7.72', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to Week 12', 'description': "The SDS is a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated higher functional impairment in the participant's work/social/family life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Enrolled participants who had baseline and at least 1 post-baseline SDS observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impressions of Severity Scale (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to Week 12', 'description': 'The CGI-S measures severity of illness at the time of assessment. Scores can range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Enrolled participants who had baseline and at least 1 post-baseline CGI-S observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.'}, {'type': 'SECONDARY', 'title': "Patient's Global Impressions of Improvement (PGI-I) Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '1.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, up to Week 12', 'description': "The PGI-I scale measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores can range from 1 (very much better) to 7 (very much worse).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Enrolled MDD participants who had at least 1 post-baseline PGI-I observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome. PGI-I observations were not completed for healthy participants.'}, {'type': 'SECONDARY', 'title': 'Hamilton Anxiety Rating Scale (HAMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'OG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom (UK) Edition (WAIS-III\\^UK). Healthy participants did not receive study drug.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.1', 'spread': '5.78', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '9.6', 'spread': '7.25', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to Week 12', 'description': 'The 14-item HAMA is used to assess the severity of anxiety. The investigator talked to the participant about their symptoms over the previous week. Each item was scored using a 5-point scale (0 = not present to 4 = very severe). Total HAMA scores could have ranged from 0 (normal) to 56 (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Enrolled participants who had a baseline and at least 1 post-baseline HAMA observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.'}, {'type': 'SECONDARY', 'title': 'Incidence of Suicidal Behavior and Suicidal Ideation as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}], 'classes': [{'title': 'Treatment-emergent suicidal ideation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-emergent suicidal behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 12', 'description': 'The C-SSRS captures the occurrence, severity, and frequency of treatment-emergent suicide-related thoughts and behaviors. Suicidal ideation is defined as a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent outcomes were the worsening or new occurrence of suicidal behaviors or ideation during treatment compared with baseline.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants with MDD who had a baseline and at least 1 post-baseline C-SSRS assessment. Healthy participants did not have a C-SSRS assessment post baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'FG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Duloxetine', 'description': 'Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters \\[defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7\\] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score \\>7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.'}, {'id': 'BG001', 'title': 'Healthy Participants', 'description': 'Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.21', 'spread': '11.23', 'groupId': 'BG000'}, {'value': '39.19', 'spread': '9.41', 'groupId': 'BG001'}, {'value': '39.74', 'spread': '10.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-02', 'studyFirstSubmitDate': '2010-01-15', 'resultsFirstSubmitDate': '2014-02-17', 'studyFirstSubmitQcDate': '2010-01-15', 'lastUpdatePostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-17', 'studyFirstPostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to 12-Week Endpoint in the Functional Magnetic Resonance Imaging (fMRI) Mean Blood Oxygenation-Level-Dependent (BOLD) Response in the Amygdalae', 'timeFrame': 'Baseline, Week 12', 'description': 'Functional MRI or fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces was measured by the percentage of signal change in BOLD response from before to after sad faces processing. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Amygdala BOLD activation was calculated as an average between the left amygdala activation and right amygdala activation. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to 12-Week Endpoint in Activation [Blood Oxygenation-Level-Dependent (BOLD) Response to Implicit Processing of Sad Faces] for Each of the 3 Brain Regions', 'timeFrame': 'Baseline, Week 12', 'description': 'Functional magnetic resonance imaging (fMRI) is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces in each brain region (anterior cingulate, left amygdala and right amygdala) was measured by the percentage of signal change in BOLD response. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.'}, {'measure': 'Change From Baseline to 12-Week Endpoint in Volume of Subgenual Anterior Cingulate, Amygdalae, and Hippocampus', 'timeFrame': 'Baseline, Week 12', 'description': 'The volume of specific brain regions is obtained using a structural magnetic resonance imaging (sMRI) procedure in which high-resolution spoiled gradient recall images are acquired in coronal brain slices. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.'}, {'measure': 'Translocation of Gs Alpha (Gsα) From Lipid Rafts in the Cell Membranes of Red Blood Cells (RBCs), White Blood Cells (WBCs) and Platelets Compared With Baseline', 'timeFrame': 'Baseline, Weeks 1, 8, and 12', 'description': 'Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Gsα localization in the cholesterol-rich (lipid rafts) and cholesterol-poor regions of cell membranes of RBCs and platelets was measured with quantitative Western blots and reported as the ratio of Gsα (absorbance units) in Triton X-100 (TX-100) over Triton X-114 (TX-114), 2 detergents that discriminate between lipid raft and non-raft membrane domains. Translocation of Gsα was measured as the change from baseline in Gsα localization. Translocation of Gsα from lipid rafts in the cell membranes of WBCs was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.'}, {'measure': 'Gs Alpha (Gsα)-Activated Adenylyl Cyclase', 'timeFrame': 'Baseline and Weeks 1, 8, and 12', 'description': 'Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Adenylyl cyclase is activated by Gsα, and when Gsα is translocated from lipid rafts it more effectively activates adenylyl cyclase. Gsα-activated adenylyl cyclase was not analyzed due to technical laboratory issues.'}, {'measure': 'Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF)', 'timeFrame': 'Baseline, Week 12', 'description': 'There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.'}, {'measure': 'Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF) Receptors', 'timeFrame': 'Baseline, Week 12', 'description': 'There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Tropomyosin receptor kinase B (trkB) is a receptor for BDNF, and pan-neurotrophin receptor p75 (p75NTR) is a receptor for proBDNF. p75NTR was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.'}, {'measure': 'Change From Baseline to 12-Week Endpoint in Proinflammatory Cytokines [Tumor Necrosis Factor Alpha (TNFα), Interleukin 1 (IL-1), and Interleukin 6 (IL-6)]', 'timeFrame': 'Baseline, Week 12', 'description': 'Cytokines are naturally produced and regulate responses to inflammation. Proinflammatory cytokines like TNFα, IL-1, and IL-6 increase inflammation in the body. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.'}, {'measure': '17-Item Hamilton Depression Rating Scale (HAMD17)', 'timeFrame': 'Baseline and up to Week 12', 'description': 'The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed).'}, {'measure': 'Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Response', 'timeFrame': 'Baseline, up to Week 12', 'description': 'HAMD17 response is defined as a \\>50% reduction in HAMD17 total score from baseline. The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with a HAMD17 response was calculated as the number of participants with a \\>50% reduction in HAMD17 total score from baseline divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.'}, {'measure': 'Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Remission', 'timeFrame': 'Baseline, up to Week 12', 'description': 'HAMD17 remission is defined as a HAMD17 total score of ≤7 at Week 12 (endpoint). The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with remission was calculated as the number of participants with a HAMD17 total score of ≤7 divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.'}, {'measure': 'Sheehan Disability Scale (SDS)', 'timeFrame': 'Baseline and up to Week 12', 'description': "The SDS is a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated higher functional impairment in the participant's work/social/family life."}, {'measure': 'Clinical Global Impressions of Severity Scale (CGI-S)', 'timeFrame': 'Baseline and up to Week 12', 'description': 'The CGI-S measures severity of illness at the time of assessment. Scores can range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).'}, {'measure': "Patient's Global Impressions of Improvement (PGI-I) Scale", 'timeFrame': 'Baseline, up to Week 12', 'description': "The PGI-I scale measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores can range from 1 (very much better) to 7 (very much worse)."}, {'measure': 'Hamilton Anxiety Rating Scale (HAMA)', 'timeFrame': 'Baseline and up to Week 12', 'description': 'The 14-item HAMA is used to assess the severity of anxiety. The investigator talked to the participant about their symptoms over the previous week. Each item was scored using a 5-point scale (0 = not present to 4 = very severe). Total HAMA scores could have ranged from 0 (normal) to 56 (severe).'}, {'measure': 'Incidence of Suicidal Behavior and Suicidal Ideation as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline through Week 12', 'description': 'The C-SSRS captures the occurrence, severity, and frequency of treatment-emergent suicide-related thoughts and behaviors. Suicidal ideation is defined as a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent outcomes were the worsening or new occurrence of suicidal behaviors or ideation during treatment compared with baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder', 'Healthy Participants']}, 'referencesModule': {'references': [{'pmid': '25880400', 'type': 'DERIVED', 'citation': 'Fu CH, Costafreda SG, Sankar A, Adams TM, Rasenick MM, Liu P, Donati R, Maglanoc LA, Horton P, Marangell LB. Multimodal functional and structural neuroimaging investigation of major depressive disorder following treatment with duloxetine. BMC Psychiatry. 2015 Apr 14;15:82. doi: 10.1186/s12888-015-0457-2.'}]}, 'descriptionModule': {'briefSummary': 'Previous research studies have shown that depression is associated with changes in structure and activity in different parts of the brain and that antidepressant medication can affect brain activity in different parts of the brain in individuals suffering from depression. The primary purpose of the study is to find out more about how the antidepressant medication duloxetine affects brain activity and structure in individuals with depression.', 'detailedDescription': 'This study will evaluate participants with depression before treatment is initiated and during treatment, and compare them to a control group of healthy participants. The aim will be to better understand both the neurobiology of depression and how the neurobiology changes in response to treatment of depression and the outcome of treatment. The study will include a variety of assessments of the neurobiology of depression including: scans of brain areas are involved in depression by looking at structures in the brain and how they work and blood tests and how these change in relation to several measures of depression severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nMajor Depressive Disorder (MDD) participants:\n\n* Are right-handed\n* Meet criteria for single episode or recurrent MDD, without psychotic features, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by Structured Clinical Interview for DSM-IV-TR (SCID-IV), without co-morbid DSM-IV Axis I or II disorder at screening\n* Be free of current antidepressant medication for a minimum of 6 weeks for fluoxetine treatment or of 4 weeks of other antidepressant treatment\n* Have a 17-item Hamilton Depression Rating Scale (HAMD17) total score of ≥18 at screening, and baseline\n* Women of child-bearing potential must have negative urine pregnancy tests prior to enrollment and agree to use a reliable method of birth control during the study\n\nHealthy Participants\n\n* Are right-handed\n* Have a HAMD17 total score of \\<7 at screening and baseline and must not meet the criteria for MDD based on the SCID-IV\n\nExclusion Criteria:\n\nMDD participants and healthy participants:\n\n* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device\n* Treatment within the last 30 days with a drug that has not received regulatory approval\n* Have previously completed or withdrawn from this study or any other study investigating duloxetine\n* Have a history of substance abuse or dependence within the past 6 months\n* A positive urine drug screen for any substances of abuse or dependence\n* Have any current DSM-IV-TR co-morbid Axis I or II disorder as determined by participant's history or investigator assessment\n* Have any history of bipolar disorder, a primary psychotic disorder (schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder), known Alzheimer's disease or mental retardation, or obsessive-compulsive disorder as determined by participant's history or investigator assessment\n* Pregnant women, women who are breast-feeding, or women of childbearing potential who are not using a medically accepted means of contraception when engaging in sexual intercourse or have been surgically sterilized\n* Are judged by the investigator to have serious suicidal risk or risk of self-harm\n* Have a history of recurrent self-mutilation or self-harm\n* Have uncontrolled narrow-angle glaucoma\n* Have been diagnosed with an acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C)\n* Have end-stage renal disease, a prior renal transplant, current renal dialysis, or severe renal impairment\n* Have abnormal thyroid-stimulating hormone (TSH) concentration\n* Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within the past year\n* Initiating psychotherapy within 6 weeks prior to study entry or during study participation, stopping, or changing psychotherapy after study entry\n* Have frequent and/or severe allergic reactions with multiple medications, or known allergic reactions to the study medication\n* Known hypersensitivity to duloxetine or any of the inactive ingredients\n* Lack of response of the current episode to two or more adequate courses of antidepressant therapy at a clinically appropriate dose for a minimum of 4 weeks or in the judgment of the investigator the participant meets criteria for treatment-resistant depression\n* Known human immunodeficiency virus (HIV) and other medical disorders that are known to affect central nervous system (CNS) structures or function as assessed by the investigator (for example, CNS neoplasms, neurosyphilis)\n* Have a medical illness, a clinically significant laboratory abnormality, or is taking a CNS active medication that, in the opinion of the investigator, might interfere with study participation (for example, is likely to require hospitalization) or that, in the opinion of the investigator, might interfere with the interpretation of the primary endpoint (for example, hypertension or diabetes)\n* Are unwilling or unable to comply with the study procedures"}, 'identificationModule': {'nctId': 'NCT01051466', 'briefTitle': 'A Study of the Neurobiology of Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Neurobiological Correlates of Antidepressant Response After Duloxetine Hydrochloride Treatment in Subjects With Major Depressive Disorder', 'orgStudyIdInfo': {'id': '12875'}, 'secondaryIdInfos': [{'id': 'F1J-US-HMGO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duloxetine', 'interventionNames': ['Drug: Duloxetine']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Participants'}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['Cymbalta, LY248686'], 'description': '60 milligrams (mg) administered orally daily for 8 weeks then 60-120 mg if non remitter or 60 mg if remitter for 4 additional weeks', 'armGroupLabels': ['Duloxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 8AF', 'city': 'London', 'state': 'United Kingdom', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}