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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 2:36 AM

Ignite Modification Date: 2025-12-26 @ 1:13 AM

Study NCT ID: NCT00840034

Status: COMPLETED

Last Update Posted: 2018-04-24

First Post: 2009-02-09

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: A Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'C568831', 'term': 'alpha-((5-fluoro-2-methoxyphenyl)methyl)-alpha-(tetrahydro-2H-pyran-4-yl)-2-morpholinemethanol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally, once daily for up to 10 weeks followed by a 2-week Taper Phase.', 'otherNumAtRisk': 111, 'otherNumAffected': 65, 'seriousNumAtRisk': 111, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets orally, once daily for up to 12 weeks.', 'otherNumAtRisk': 116, 'otherNumAffected': 48, 'seriousNumAtRisk': 116, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'LY2216684-Taper Phase', 'description': 'LY2216684: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks were administered 12 mg orally, once daily for 1 week followed by 6 mg once daily for 1 week or 6 mg orally, once daily for 2 weeks.', 'otherNumAtRisk': 90, 'otherNumAffected': 8, 'seriousNumAtRisk': 90, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo-Taper Phase', 'description': 'Placebo: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks continued on placebo 3 tablets orally, once daily for 2 weeks.', 'otherNumAtRisk': 82, 'otherNumAffected': 8, 'seriousNumAtRisk': 82, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Uterine hypoplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sluggishness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, 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'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Onychoclasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Peripheral coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.71', 'spread': '0.625', 'groupId': 'OG000'}, {'value': '-2.97', 'spread': '0.628', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). The total score ranges from 0 to 27 with higher scores indicating greater severity of depression. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline QIDS-SR16 Total Score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'title': 'Highest Score from Items 1-4', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.115', 'groupId': 'OG001'}]}]}, {'title': 'Item 5', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.124', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.126', 'groupId': 'OG001'}]}]}, {'title': 'Highest Score from Items 6-9', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.131', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.133', 'groupId': 'OG001'}]}]}, {'title': 'Item 10', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.095', 'groupId': 'OG001'}]}]}, {'title': 'Item 11', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.127', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.129', 'groupId': 'OG001'}]}]}, {'title': 'Item 12', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Item 13', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.139', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.140', 'groupId': 'OG001'}]}]}, {'title': 'Item 14', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.109', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.110', 'groupId': 'OG001'}]}]}, {'title': 'Highest Score from Items 15-16', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.130', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). Least Squares (LS) means are calculated using mixed model repeated measure (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline QIDS-SR16 Individual Score.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to 8 Weeks in Montgomery-Asberg Depression Rating Scale (MADRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.13', 'spread': '1.251', 'groupId': 'OG000'}, {'value': '-5.76', 'spread': '1.249', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS is a 10-item checklist with items rated on a scale of 0-6, for a total scores range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for investigator, treatment-by-visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline MADRS Total Score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 8 Weeks in Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'title': 'Anxiety Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.19', 'spread': '0.484', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '0.483', 'groupId': 'OG001'}]}]}, {'title': 'Depression Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.28', 'spread': '0.549', 'groupId': 'OG000'}, {'value': '-1.93', 'spread': '0.551', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 8 weeks', 'description': "HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for each subscale. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 is 'normal.' Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, visit, treatment-by-visit, investigator, and baseline score.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline HADS Score; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 8 Weeks in Clinical Global Impression of Severity (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.135', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.135', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'CGI-S measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline CGI-Severity Score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 8 Weeks in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.69', 'spread': '0.831', 'groupId': 'OG000'}, {'value': '-2.62', 'spread': '0.833', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': "The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42. Higher scores indicate greater disease severity. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline CPFQ Total Score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 8 Weeks in Fatigue Associated With Depression Participant-Reported Outcome (FAsD PRO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'title': 'Overall Average Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.124', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.127', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Experience Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.126', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.129', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Impact Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.92', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.140', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 8 weeks', 'description': 'The FAsD PRO is a 16-item participant-rated scale. Seven items ask how often the participants experience different aspects of fatigue with each item rated on a 5-point scale: 1 (Never) to 5 (Always). Nine items ask how often fatigue impacts various aspects of the participants lives with each item rated on a 5-point scale: 1 (Not at all) to 5 (Very much). The Fatigue Experience Score is the mean of Items 1-5, and 7, the Fatigue Impact Score is the mean of Items 8-12, 14, and 16, and the Overall Average Score is the mean of Items 1-5, 7-12, 14 and 16. The Experience, Impact and Overall Mean Scores range from 1 to 5, lower scores indicate less experience/impact. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline FAsD-PRO Score; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 8 Weeks in Visual Analog Scale for Fatigue (VAS-F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'title': 'Severity', 'categories': [{'measurements': [{'value': '-16.42', 'spread': '3.407', 'groupId': 'OG000'}, {'value': '-13.81', 'spread': '3.412', 'groupId': 'OG001'}]}]}, {'title': 'Interference', 'categories': [{'measurements': [{'value': '-18.91', 'spread': '3.698', 'groupId': 'OG000'}, {'value': '-10.33', 'spread': '3.701', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 8 weeks', 'description': 'VAS-F is a self-rated assessment on 2 items: the overall severity of fatigue and the interferences with daily activities due to fatigue. For the overall severity of fatigue the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to fatigue, the participant is asked to place a vertical mark on a 100 mm line between 2 anchors: 0 (not at all) and 100 \\[complete disability (unable to do any activities)\\]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline VAS-F Score; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 8 Weeks in Visual Analog Scale for Pain (VAS-P)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'title': 'Severity', 'categories': [{'measurements': [{'value': '-4.17', 'spread': '3.450', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '3.448', 'groupId': 'OG001'}]}]}, {'title': 'Interference', 'categories': [{'measurements': [{'value': '-9.56', 'spread': '3.611', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '3.613', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 8 weeks', 'description': 'VAS-P is a self-rated assessment for 2 items: the overall severity of pain and the interferences with daily activities due to pain. For the overall severity of pain the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to pain, the participant is asked to place a vertical mark on a 100-mm line between 2 anchors: 0 (not at all) and 100 \\[complete disability (unable to do any activities)\\]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline VAS-P Score; last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 8 Weeks in Sheehan Disability Scale (SDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.95', 'spread': '1.116', 'groupId': 'OG000'}, {'value': '-2.63', 'spread': '1.123', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 8 weeks', 'description': "The SDS is a 3-item, participant completed assessment and is used to assess the effect of the participant's symptoms on their work/social/family life. The Global Functional Impairment Total Score is a total of the 3 individual item scores, each with a scores range from 0 (not at all) to 10 (extremely). The Global Functional Impairment Total Scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis is determined by treatment group participants are randomly assigned regardless of treatment received, includes all participants who do not respond in Weeks 1-2, have baseline and at least 1 post-baseline SDS Total Score; last observation carried forward. Missing work score imputed with average of other 2-item scores.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 8 Weeks in Quality of Life Enjoyment and Satisfaction Survey-Short Form (Q-LES-Q-SF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.94', 'spread': '2.073', 'groupId': 'OG000'}, {'value': '5.44', 'spread': '2.078', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 8 weeks', 'description': 'The Q-LES-Q-SF is a self-administered 16-item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week, and is rated on a 5-point Likert scale: 1 (very poor) to 5 (very good). The Q-LES-Q-SF Total Raw Score is the sum of Items 1 to 14 and ranges from 14 to 70. The Q-LES-Q-SF Raw Scores are converted to, and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.', 'unitOfMeasure': 'percentage of the maximum possible score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis is determined by treatment group participants are randomly assigned regardless of treatment received, includes all participants who do not respond in Weeks 1-2, have baseline and at least 1 post-baseline Q-LES-Q-SF Total Score; last observation carried forward. If ≤2 items are missing mean of all other items are imputed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'title': 'Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.133', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.136', 'groupId': 'OG001'}]}]}, {'title': 'Arousal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.132', 'groupId': 'OG001'}]}]}, {'title': 'Ability to Reach Orgasm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.144', 'groupId': 'OG001'}]}]}, {'title': 'Erectile Function - Males Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.237', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.233', 'groupId': 'OG001'}]}]}, {'title': 'Overall Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.144', 'groupId': 'OG001'}]}]}, {'title': 'Overall Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.45', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '3.62', 'spread': '0.121', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 8 weeks', 'description': 'The MGH-SFQ is a 6-item participant-rated scale quantifying sexual interest, arousal (subjective excitement), ability to reach orgasm, erectile function (for males), and overall satisfaction and are scored on a 6-point scale: 1 (greater than normal) to 6 (totally absent); and overall improvement since last medication change is scored on a 6-point scale: 1 (very much improved) to 6 (much worse). Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline MGH-SFQ Score.'}, {'type': 'SECONDARY', 'title': 'Colombia-Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'title': 'Suicidal Ideation', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal Behavior', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal Acts', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Percent of participants with suicidal ideation, behavior and acts based on C-SSRS. The C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any 1 of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide). Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions (wish to be dead, and 4 different categories of active suicidal ideation). Suicidal act: a "yes" answer to actual attempt or completed suicide.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline C-SSRS Score.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline to 8 Weeks in Supine Systolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '3.61', 'spread': '1.131', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '1.195', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '2.67', 'spread': '0.730', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.772', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Blood pressure is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'millimeters of mercury (mm Hg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who have baseline and at least 1 post-baseline supine systolic and diastolic blood pressure measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline to 8 Weeks in Supine Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.74', 'spread': '0.986', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '1.038', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Pulse is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and included all participants who have baseline and at least 1 post-baseline supine pulse rate measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets varying in strength) administered orally, once daily for up to 10 weeks, followed by a 2-week Taper Phase.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}], 'periods': [{'title': 'Acute Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}, {'title': 'Taper Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Completed Acute Treatment (AT) or discontinued ≥4 weeks of AT and chose to participate in Taper.', 'groupId': 'FG000', 'numSubjects': '90'}, {'comment': 'Completed Acute Treatment (AT) or discontinued ≥4 weeks of AT and chose to participate in Taper.', 'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], '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': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'In the Acute Treatment Phase participants are randomized to either LY2216684 or placebo treatment groups. Participants who complete the Acute Treatment Phase or discontinue early after 4 or more weeks in the Acute Treatment phase are eligible to participate in the 2 week Taper Phase, but not all elected to participate.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LY2216684', 'description': 'LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: 3 tablets PO QD for up to 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.1', 'spread': '10.71', 'groupId': 'BG000'}, {'value': '44.1', 'spread': '10.90', 'groupId': 'BG001'}, {'value': '45.0', 'spread': '10.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'dispFirstSubmitDate': '2010-10-25', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-25', 'studyFirstSubmitDate': '2009-02-09', 'dispFirstSubmitQcDate': '2010-10-25', 'resultsFirstSubmitDate': '2018-02-17', 'studyFirstSubmitQcDate': '2009-02-09', 'dispFirstPostDateStruct': {'date': '2010-10-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-25', 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline to 8 Weeks in Supine Systolic and Diastolic Blood Pressure', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Blood pressure is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.'}, {'measure': 'Change From Baseline to 8 Weeks in Supine Pulse', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Pulse is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline to 8 Weeks in Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS is a 10-item checklist with items rated on a scale of 0-6, for a total scores range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for investigator, treatment-by-visit, baseline score, and baseline-by-visit.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Total Score', 'timeFrame': 'Baseline, 8 weeks', 'description': 'QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). The total score ranges from 0 to 27 with higher scores indicating greater severity of depression. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.'}, {'measure': 'Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items', 'timeFrame': 'Baseline, 8 weeks', 'description': 'QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). Least Squares (LS) means are calculated using mixed model repeated measure (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.'}, {'measure': 'Change From Baseline to 8 Weeks in Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline, up to 8 weeks', 'description': "HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for each subscale. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 is 'normal.' Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, visit, treatment-by-visit, investigator, and baseline score."}, {'measure': 'Change From Baseline to 8 Weeks in Clinical Global Impression of Severity (CGI-S)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'CGI-S measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by visit, baseline score, and baseline-by-visit.'}, {'measure': 'Change From Baseline to 8 Weeks in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)', 'timeFrame': 'Baseline, 8 weeks', 'description': "The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42. Higher scores indicate greater disease severity. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit."}, {'measure': 'Change From Baseline to 8 Weeks in Fatigue Associated With Depression Participant-Reported Outcome (FAsD PRO)', 'timeFrame': 'Baseline, up to 8 weeks', 'description': 'The FAsD PRO is a 16-item participant-rated scale. Seven items ask how often the participants experience different aspects of fatigue with each item rated on a 5-point scale: 1 (Never) to 5 (Always). Nine items ask how often fatigue impacts various aspects of the participants lives with each item rated on a 5-point scale: 1 (Not at all) to 5 (Very much). The Fatigue Experience Score is the mean of Items 1-5, and 7, the Fatigue Impact Score is the mean of Items 8-12, 14, and 16, and the Overall Average Score is the mean of Items 1-5, 7-12, 14 and 16. The Experience, Impact and Overall Mean Scores range from 1 to 5, lower scores indicate less experience/impact. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.'}, {'measure': 'Change From Baseline to 8 Weeks in Visual Analog Scale for Fatigue (VAS-F)', 'timeFrame': 'Baseline, up to 8 weeks', 'description': 'VAS-F is a self-rated assessment on 2 items: the overall severity of fatigue and the interferences with daily activities due to fatigue. For the overall severity of fatigue the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to fatigue, the participant is asked to place a vertical mark on a 100 mm line between 2 anchors: 0 (not at all) and 100 \\[complete disability (unable to do any activities)\\]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.'}, {'measure': 'Change From Baseline to 8 Weeks in Visual Analog Scale for Pain (VAS-P)', 'timeFrame': 'Baseline, up to 8 weeks', 'description': 'VAS-P is a self-rated assessment for 2 items: the overall severity of pain and the interferences with daily activities due to pain. For the overall severity of pain the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to pain, the participant is asked to place a vertical mark on a 100-mm line between 2 anchors: 0 (not at all) and 100 \\[complete disability (unable to do any activities)\\]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.'}, {'measure': 'Change From Baseline to 8 Weeks in Sheehan Disability Scale (SDS)', 'timeFrame': 'Baseline, up to 8 weeks', 'description': "The SDS is a 3-item, participant completed assessment and is used to assess the effect of the participant's symptoms on their work/social/family life. The Global Functional Impairment Total Score is a total of the 3 individual item scores, each with a scores range from 0 (not at all) to 10 (extremely). The Global Functional Impairment Total Scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score."}, {'measure': 'Change From Baseline to 8 Weeks in Quality of Life Enjoyment and Satisfaction Survey-Short Form (Q-LES-Q-SF)', 'timeFrame': 'Baseline, up to 8 weeks', 'description': 'The Q-LES-Q-SF is a self-administered 16-item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week, and is rated on a 5-point Likert scale: 1 (very poor) to 5 (very good). The Q-LES-Q-SF Total Raw Score is the sum of Items 1 to 14 and ranges from 14 to 70. The Q-LES-Q-SF Raw Scores are converted to, and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.'}, {'measure': 'Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)', 'timeFrame': 'Baseline, up to 8 weeks', 'description': 'The MGH-SFQ is a 6-item participant-rated scale quantifying sexual interest, arousal (subjective excitement), ability to reach orgasm, erectile function (for males), and overall satisfaction and are scored on a 6-point scale: 1 (greater than normal) to 6 (totally absent); and overall improvement since last medication change is scored on a 6-point scale: 1 (very much improved) to 6 (much worse). Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.'}, {'measure': 'Colombia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Percent of participants with suicidal ideation, behavior and acts based on C-SSRS. The C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any 1 of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide). Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions (wish to be dead, and 4 different categories of active suicidal ideation). Suicidal act: a "yes" answer to actual attempt or completed suicide.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depressive Disorder, Major']}, 'referencesModule': {'references': [{'pmid': '27685842', 'type': 'DERIVED', 'citation': 'Stauffer VL, Liu P, Goldberger C, Marangell LB, Nelson C, Gorwood P, Fava M. Is the Noradrenergic Symptom Cluster a Valid Construct in Adjunctive Treatment of Major Depressive Disorder? J Clin Psychiatry. 2017 Mar;78(3):317-323. doi: 10.4088/JCP.15m09972.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose is to study the efficacy, safety, and tolerability of LY2216684 as an adjunctive treatment for participants with major depressive disorder (MDD), who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) (as defined by history).', 'detailedDescription': 'This is a 12 week multi-center, double-blind, placebo-controlled study on the efficacy of LY2216684 augmentation of selective serotonin reuptake inhibitors (SSRIs) in participants with MDD who have a partial response to treatment with an SSRI. While remaining on a steady dose of their SSRI treatment at entry into the study, participants will be randomly assigned to adjunctive treatment with LY2216684 or placebo in a 1:1 ratio for 10 weeks of acute treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet criteria for major depressive disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR criteria)\n* Meet criteria for partial response to an adequate course of treatment defined by the investigator's opinion that participant had attained at least minimal improvement on their current Selective serotonin reuptake inhibitor (SSRI) treatment\n* Women of child-bearing potential must test negative for pregnancy and agree to use a reliable method of birth control\n* Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or equal 16 to at both study entry and study enrollment\n* SSRI treatment for at least 6 weeks at a stable dose for at least 2 weeks prior to study enrollment\n* Stated participant preference for augmentation rather than switching antidepressant treatment\n\nExclusion Criteria:\n\n* Are currently involved in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug\n* Have previously completed or withdrawn from this study or any other study investigating LY2216684\n* Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than MDD\n* Have had any anxiety disorder preceding the onset of depression that was considered the primary diagnosis within 1 year of study entry\n* Have a current or previous diagnosis of Bipolar I or II, psychotic depression, schizophrenia or other psychotic disorder\n* Have a history of substance abuse within the past 1 year\n* Have an Axis II disorder which, in the judgment of the investigator, would interfere with compliance with the protocol\n* Have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the participant has treatment-resistant depression\n* Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or psychosurgery within the last year\n* Women who are pregnant or breastfeeding\n* Participants who are judged to be at serious risk for harm to self or others\n* Have a serious or unstable medical illness\n* Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitation or retention\n* Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions\n* Have a history of any seizure disorder (other than febrile seizures)\n* Are taking noradrenergic psychotropic medications, such as tricyclic antidepressants or serotonin norepinephrine reuptake inhibitors (SNRI)\n* Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to study entry\n* Require psychotropic medication other than sedative/hypnotic medication for sleep\n* Are taking or have received treatment with any excluded medication within 7 days prior to study enrollment\n* Have a thyroid stimulating hormone (TSH ) level outside the established reference range\n* Have initiate or discontinued hormone therapy within the previous 3 months prior to enrollment\n* Initiation or change in intensity of psychotherapy or other non-drug therapies within 6 weeks prior to enrollment\n* A positive urine drug screen for any substance of abuse at study entry"}, 'identificationModule': {'nctId': 'NCT00840034', 'briefTitle': 'A Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Study of Augmentation With LY2216684 for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment', 'orgStudyIdInfo': {'id': '12850'}, 'secondaryIdInfos': [{'id': 'H9P-MC-LNDK', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2216684', 'interventionNames': ['Drug: LY2216684']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY2216684', 'type': 'DRUG', 'description': 'Starting dose is 6 milligrams (mg), then titrate up to 9 mg, 12 mg, or 18 mg (3 tablets) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2 week taper.', 'armGroupLabels': ['LY2216684']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3 tablets PO QD for up to 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', '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': 33.52066, 'lon': -86.80249}}, {'zip': '72223', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', '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': 34.74648, 'lon': -92.28959}}, {'zip': '90746', 'city': 'Carson', 'state': 'California', 'country': 'United States', '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': 33.83141, 'lon': -118.28202}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', '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': 33.64113, 'lon': -117.91867}}, {'zip': '92701', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', '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': 33.74557, 'lon': -117.86783}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', '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': 33.83585, 'lon': -118.34063}}, {'zip': '80239', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', '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': 39.73915, 'lon': -104.9847}}, {'zip': '33067', 'city': 'Coral Springs', 'state': 'Florida', 'country': 'United States', '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': 26.27119, 'lon': -80.2706}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', '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': 30.33218, 'lon': -81.65565}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', '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': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', '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': 28.53834, 'lon': -81.37924}}, {'zip': '30080', 'city': 'Smyrna', 'state': 'Georgia', 'country': 'United States', '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': 33.88399, 'lon': -84.51438}}, {'zip': '60523', 'city': 'Oak Brook', 'state': 'Illinois', 'country': 'United States', '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': 41.83281, 'lon': -87.92895}}, {'zip': '47905', 'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', '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': 40.4167, 'lon': -86.87529}}, {'zip': '21285', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', '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': 39.29038, 'lon': -76.61219}}, {'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', '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': 38.78394, 'lon': -90.48123}}, {'zip': '08046', 'city': 'Willingboro', 'state': 'New Jersey', 'country': 'United States', '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': 40.02789, 'lon': -74.86905}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', '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': 35.08449, 'lon': -106.65114}}, {'zip': '11366', 'city': 'Fresh Meadows', 'state': 'New York', 'country': 'United States', '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': 40.73482, 'lon': -73.79347}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', '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': 43.15478, 'lon': -77.61556}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', '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': 39.95238, 'lon': -75.16362}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', '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': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', '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': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', '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': 29.42412, 'lon': -98.49363}}], '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'}}}}