Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-29 @ 12:06 AM
Study NCT ID:
NCT01155661
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2010-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety Study in Participants With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Portugal']}, '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'}, {'id': 'D017367', 'term': 'Selective Serotonin Reuptake Inhibitors'}], 'ancestors': [{'id': 'D014179', 'term': 'Neurotransmitter Uptake Inhibitors'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D018490', 'term': 'Serotonin Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, '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 + SSRI Open-Label Phase', 'description': "LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI); included all enrolled participants who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.", 'otherNumAtRisk': 600, 'otherNumAffected': 448, 'seriousNumAtRisk': 600, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Discontinuation Phase', 'description': "Included all enrolled participants who abruptly discontinued LY2216684 (edivoxetine) treatment either at the end of the study or after early withdrawal from the study and who did not discontinue from the study for the reason 'Lost to follow-up' at the discontinuation phase visit. All participants maintained their SSRI treatment at the stable dose during the discontinuation phase.", 'otherNumAtRisk': 472, 'otherNumAffected': 99, 'seriousNumAtRisk': 472, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 77, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 58, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 99, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 46, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 39, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 50, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 107, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 59, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 38, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 93, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'notes': 'resulted in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oesophageal rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bartholinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 362, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 472, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants Experiencing Clinically Significant Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 54 weeks', 'description': 'A clinically significant effect was defined as a serious adverse event, regardless of causality.\n\nA summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled participants who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit."}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Suicidal Ideation and Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'title': 'Suicidal Ideation', 'categories': [{'measurements': [{'value': '11.71', 'groupId': 'OG000'}]}]}, {'title': 'Suicidal Behavior', 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 54', 'description': 'The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline C-SSRS value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 54 Week Endpoint in the Arizona Sexual Experiences (ASEX) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '537', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.28', 'spread': '0.25', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', 'description': 'The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 \\[extremely\\] to 6 \\[no/never\\]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30 with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline ASEX total score value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 54 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '541', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.64', 'spread': '0.30', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', '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 was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline CPFQ total score value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'title': 'MADRS Item 1: Apparent Sadness', 'categories': [{'measurements': [{'value': '-2.17', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': 'MADRS Item 2: Reported Sadness', 'categories': [{'measurements': [{'value': '-2.38', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'MADRS Item 3: Inner Tension', 'categories': [{'measurements': [{'value': '-1.56', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'MADRS Item 4: Reduced Sleep', 'categories': [{'measurements': [{'value': '-1.97', 'spread': '0.07', 'groupId': 'OG000'}]}]}, {'title': 'MADRS Item 5: Reduced Appetite', 'categories': [{'measurements': [{'value': '-1.08', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'MADRS Item 6: Concentration Difficulties', 'categories': [{'measurements': [{'value': '-1.88', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'MADRS Item 7: Lassitude', 'categories': [{'measurements': [{'value': '-2.18', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'MADRS Item 8: Inability to Feel', 'categories': [{'measurements': [{'value': '-2.22', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'MADRS Item 9: Pessimistic Thoughts', 'categories': [{'measurements': [{'value': '-1.52', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': 'MADRS Item 10: Suicidal Thoughts', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'MADRS Total Score', 'categories': [{'measurements': [{'value': '-16.97', 'spread': '0.41', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', 'description': 'The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline MADRS individual item and total score value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '588', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.32', 'spread': '0.21', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', 'description': "The Hospital Anxiety and Depression Scale (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 anxiety and depression subscales. 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, 'normal.' Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline Hospital Anxiety and Depression Scale (HADS) depression subscale value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 54 Week Endpoint in Clinical Global Impression - Severity (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.17', 'spread': '0.06', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', 'description': 'Clinical Global Impression - Severity (CGI-S) measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline Clinical Global Impression - Severity (CGI-S) value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 54 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '541', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'title': 'FAsD Experience Score', 'categories': [{'measurements': [{'value': '-1.25', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': 'FAsD Impact Score', 'categories': [{'measurements': [{'value': '-1.37', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': 'FAsD Average Score', 'categories': [{'measurements': [{'value': '-1.30', 'spread': '0.05', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', 'description': 'The Fatigue Associated with Depression (FAsD) is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant\'s lives with responses from 1 (not at all) to 5 (very much). The "Experience Score" was derived by taking the mean of Items 1 through 6, the "Impact Score" was derived by taking the mean of Items 7 through 13 (applicable items only), and the "Average Score" was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline Fatigue Associated with Depression (FAsD) average score and subscale score.'}, {'type': 'SECONDARY', 'title': 'Probability of Meeting the Response Criteria for Depressive Symptoms at Week 54 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.772', 'spread': '0.020', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 54', 'description': 'Response criteria was defined as at least a 50% decrease from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). This analysis models the probability of response at each visit, and the estimated probabilities were adjusted for visit and the baseline MADRS total score.', 'unitOfMeasure': 'Probability of response', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.'}, {'type': 'SECONDARY', 'title': 'Probability of Meeting the Remission Criteria for Depressive Symptoms at Week 54 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.758', 'spread': '0.022', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 54', 'description': 'Remission criteria was defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of \\<= 10. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). This analysis models the probability of remission at each visit, and the estimated probabilities were adjusted for visit and the baseline MADRS total score.', 'unitOfMeasure': 'Probability of remission', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Meet Response Criteria of Depressive Symptoms by Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8', 'description': 'Response criteria was defined as at least a 50% decrease from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Kaplan-Meier product limit method of time to first response was calculated. In the calculation, participants who did not meet response criteria were considered as right-censored observations. The estimated percentage of participants who met response criteria by Week 8 from the Kaplan-Meier method is presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '588', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.57', 'spread': '0.18', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', 'description': "The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline Hospital Anxiety and Depression Scale (HADS) anxiety subscale value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 54 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'title': 'SDS Global Functional Impairment(Imp) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.71', 'spread': '0.37', 'groupId': 'OG000'}]}]}, {'title': 'Work/School Imp Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.36', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'Social Life/Leisure Activity Imp Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.74', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Family Life/Home Responsibility Imp Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.61', 'spread': '0.13', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', 'description': "The Sheehan Disability Scale (SDS) Global Functional Impairment Score (total score) and Subscores were completed by the participant and were used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment \\[imp\\] score), social life (social life/leisure activities impairment \\[imp\\] score), and family life (family life/home responsibilities impairment \\[imp\\] score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline Sheehan Disability Scale (SDS) subscale score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 54 Week Endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '23.607', 'spread': '1.019', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', 'description': 'The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline EuroQol Questionnaire - 5 Dimension (EQ-5D) visual analog scale value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 54 Week Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '21.56', 'spread': '0.90', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', 'description': 'The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (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 on a 5-point Likert scale (1=very poor and 5=very good). The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70. The 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 were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) percent of maximum possible score value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported Resource Utilization (RU) at Baseline and at the Week 54 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'title': 'Primary Care Doctor Visits, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.27', 'groupId': 'OG000'}]}]}, {'title': 'Primary Care Doctor Visits, Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.18', 'groupId': 'OG000'}]}]}, {'title': 'Psychiatrist Visits, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.15', 'groupId': 'OG000'}]}]}, {'title': 'Psychiatrist Visits, Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 54', 'description': 'The Resource Utilization (RU) form assesses the frequency and type of medical services (a primary care visit and/or a psychiatrist visit) that participants used within the previous year (for the baseline visit) or within approximately the previous 3 months (for post-baseline visits or the Week 54 endpoint). The percentage of participants who reported greater than zero number of primary care doctor visits and greater than zero number of psychiatrist visits is presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline Resource Utilization value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Discontinuation-Emergent Adverse Events (DEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '20.97', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to1 week after discontinuation of treatment', 'description': 'Discontinuation-emergent adverse events (DEAEs) were events that first occurred or worsened within 1-week after abrupt discontinuation of LY2216684 (edivoxetine) treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled participants who abruptly discontinued LY2216684 (edivoxetine) treatment either at the end of the study or after early withdrawal from the study and who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Meet Remission Criteria of Depressive Symptoms by Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '47.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8', 'description': 'Remission criteria was defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of \\<= 10. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Kaplan-Meier product limit method of time to first remission was calculated. In the calculation, participants who did not meet remission criteria were considered as right-censored observations. The estimated percentage of participants who meet remission criteria by Week 8 from the Kaplan-Meier method is presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of LY2216684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684: 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'title': '12 mg dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '496', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.6', 'spread': '21.4', 'groupId': 'OG000'}]}]}, {'title': '18 mg dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.6', 'spread': '35.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 6, and 8', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with at least one plasma sample.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Experiencing Clinically Significant Effects as a Function of CYP2D6 Predicted Phenotype at Week 54 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'title': 'Poor Metabolizer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Non-poor Metabolizer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '408', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 54', 'description': 'A clinically significant effect was defined as a treatment-emergent adverse event; a reported adverse event that first occurred or worsened during the treatment phase. CYP2D6 predicted phenotype was classified as poor metabolizer (PM) or non-poor metabolizer (non-PM). The number of participants who reported at least one treatment-emergent adverse event is presented for each phenotype classification.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled participants who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 54 Week Endpoint in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'title': 'Sitting Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '2.28', 'spread': '0.50', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '2.17', 'spread': '0.40', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', 'description': 'Blood pressure measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline value, and baseline-by-visit.', 'unitOfMeasure': 'millimeters of mercury (mm Hg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline blood pressure value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 54 Endpoint in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.01', 'spread': '0.49', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 54', 'description': 'Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline value, and baseline-by-visit.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with a baseline and at least one post-baseline pulse rate value.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '608'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '328'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '280'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}], 'preAssignmentDetails': 'There was a 54 week LY2216684 treatment Open-label Phase followed by 1 week Discontinuation Phase after abrupt discontinuation of treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'LY2216684 + SSRI', 'description': 'LY2216684 (edivoxetine): 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.54', 'spread': '12.97', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '455', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '153', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '214', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '320', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '521', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 608}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'dispFirstSubmitDate': '2013-04-30', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-16', 'studyFirstSubmitDate': '2010-06-30', 'dispFirstSubmitQcDate': '2013-04-30', 'resultsFirstSubmitDate': '2018-02-17', 'studyFirstSubmitQcDate': '2010-06-30', 'dispFirstPostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-16', 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants Experiencing Clinically Significant Effects', 'timeFrame': 'Baseline through 54 weeks', 'description': 'A clinically significant effect was defined as a serious adverse event, regardless of causality.\n\nA summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.'}], 'secondaryOutcomes': [{'measure': 'Percent of Participants With Suicidal Ideation and Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline through Week 54', 'description': 'The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.'}, {'measure': 'Change From Baseline to 54 Week Endpoint in the Arizona Sexual Experiences (ASEX) Scale', 'timeFrame': 'Baseline, Week 54', 'description': 'The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 \\[extremely\\] to 6 \\[no/never\\]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30 with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.'}, {'measure': 'Change From Baseline to 54 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)', 'timeFrame': 'Baseline, Week 54', '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 was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit."}, {'measure': 'Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items', 'timeFrame': 'Baseline, Week 54', 'description': 'The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.'}, {'measure': 'Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score', 'timeFrame': 'Baseline, Week 54', 'description': "The Hospital Anxiety and Depression Scale (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 anxiety and depression subscales. 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, 'normal.' Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit."}, {'measure': 'Change From Baseline to 54 Week Endpoint in Clinical Global Impression - Severity (CGI-S)', 'timeFrame': 'Baseline, Week 54', 'description': 'Clinical Global Impression - Severity (CGI-S) measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.'}, {'measure': 'Change From Baseline to 54 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores', 'timeFrame': 'Baseline, Week 54', 'description': 'The Fatigue Associated with Depression (FAsD) is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant\'s lives with responses from 1 (not at all) to 5 (very much). The "Experience Score" was derived by taking the mean of Items 1 through 6, the "Impact Score" was derived by taking the mean of Items 7 through 13 (applicable items only), and the "Average Score" was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.'}, {'measure': 'Probability of Meeting the Response Criteria for Depressive Symptoms at Week 54 Endpoint', 'timeFrame': 'Baseline, Week 54', 'description': 'Response criteria was defined as at least a 50% decrease from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). This analysis models the probability of response at each visit, and the estimated probabilities were adjusted for visit and the baseline MADRS total score.'}, {'measure': 'Probability of Meeting the Remission Criteria for Depressive Symptoms at Week 54 Endpoint', 'timeFrame': 'Baseline, Week 54', 'description': 'Remission criteria was defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of \\<= 10. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). This analysis models the probability of remission at each visit, and the estimated probabilities were adjusted for visit and the baseline MADRS total score.'}, {'measure': 'Percentage of Participants Who Meet Response Criteria of Depressive Symptoms by Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Response criteria was defined as at least a 50% decrease from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Kaplan-Meier product limit method of time to first response was calculated. In the calculation, participants who did not meet response criteria were considered as right-censored observations. The estimated percentage of participants who met response criteria by Week 8 from the Kaplan-Meier method is presented.'}, {'measure': 'Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score', 'timeFrame': 'Baseline, Week 54', 'description': "The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit."}, {'measure': 'Change From Baseline to 54 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores', 'timeFrame': 'Baseline, Week 54', 'description': "The Sheehan Disability Scale (SDS) Global Functional Impairment Score (total score) and Subscores were completed by the participant and were used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment \\[imp\\] score), social life (social life/leisure activities impairment \\[imp\\] score), and family life (family life/home responsibilities impairment \\[imp\\] score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit."}, {'measure': 'Change From Baseline to 54 Week Endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D)', 'timeFrame': 'Baseline, Week 54', 'description': 'The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.'}, {'measure': 'Change From Baseline to 54 Week Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)', 'timeFrame': 'Baseline, Week 54', 'description': 'The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (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 on a 5-point Likert scale (1=very poor and 5=very good). The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70. The 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 were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.'}, {'measure': 'Percentage of Participants Who Reported Resource Utilization (RU) at Baseline and at the Week 54 Endpoint', 'timeFrame': 'Baseline, Week 54', 'description': 'The Resource Utilization (RU) form assesses the frequency and type of medical services (a primary care visit and/or a psychiatrist visit) that participants used within the previous year (for the baseline visit) or within approximately the previous 3 months (for post-baseline visits or the Week 54 endpoint). The percentage of participants who reported greater than zero number of primary care doctor visits and greater than zero number of psychiatrist visits is presented.'}, {'measure': 'Percentage of Participants With Discontinuation-Emergent Adverse Events (DEAEs)', 'timeFrame': 'Up to1 week after discontinuation of treatment', 'description': 'Discontinuation-emergent adverse events (DEAEs) were events that first occurred or worsened within 1-week after abrupt discontinuation of LY2216684 (edivoxetine) treatment.'}, {'measure': 'Percentage of Participants Who Meet Remission Criteria of Depressive Symptoms by Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Remission criteria was defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of \\<= 10. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Kaplan-Meier product limit method of time to first remission was calculated. In the calculation, participants who did not meet remission criteria were considered as right-censored observations. The estimated percentage of participants who meet remission criteria by Week 8 from the Kaplan-Meier method is presented.'}, {'measure': 'Plasma Concentration of LY2216684', 'timeFrame': 'Weeks 2, 6, and 8'}, {'measure': 'The Number of Participants Experiencing Clinically Significant Effects as a Function of CYP2D6 Predicted Phenotype at Week 54 Endpoint', 'timeFrame': 'Baseline, Week 54', 'description': 'A clinically significant effect was defined as a treatment-emergent adverse event; a reported adverse event that first occurred or worsened during the treatment phase. CYP2D6 predicted phenotype was classified as poor metabolizer (PM) or non-poor metabolizer (non-PM). The number of participants who reported at least one treatment-emergent adverse event is presented for each phenotype classification.'}, {'measure': 'Change From Baseline to 54 Week Endpoint in Blood Pressure', 'timeFrame': 'Baseline, Week 54', 'description': 'Blood pressure measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline value, and baseline-by-visit.'}, {'measure': 'Change From Baseline to Week 54 Endpoint in Pulse Rate', 'timeFrame': 'Baseline, Week 54', 'description': 'Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline value, and baseline-by-visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depressive Disorder, Major']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major depressive disorder (MDD) who are partial responders to their SSRI treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults competent and able to give informed consent\n* Women of child-bearing potential may participate but must test negative for pregnancy at the time of study entry; both women/men agree to use a reliable method of birth control\n* Participants who are being treated with one of the following selective serotonin reuptake inhibitors (SSRIs): escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and fluvoxamine; for at least 6 weeks prior to investigational product dispensing with at least the last 4 weeks at a stable, optimized dose\n* Drug and dosage should be within the labeling guidelines for the specific country\n* Meet criteria for Major Depressive Disorder (MDD), as defined by the Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria\n* Meet criteria for partial response, as defined by investigator's opinion that participant has experienced a minimal clinically meaningful improvement with SSRI\n* Have a Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or equal to 16 at screening\n* Have less than or equal to 75 percent improvement on the current SSRI at screening determined by the Massachusetts General Hospital Antidepressant Response Questionnaire (MGH-ATRQ)\n* Meet all other inclusion criteria per protocol\n\nExclusion Criteria:\n\n* Presence of another primary psychiatric illnesses:\n\n * Have had or currently have any additional ongoing DSM-IV-TR Axis I condition other than major depression within 1 year of screening\n * Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias)\n * Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder\n * Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine\n * Have a DSM-IV-TR Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol\n* Unstable medical conditions that contraindicate the use of LY2216684\n\n * Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angled glaucoma, urinary hesitation or retention\n* Use of excluded concomitant or psychotropic medication other than SSRI\n* Have initiated or discontinued hormone therapy within the previous 3 months of prior to enrollment\n* History of treatment resistant depression as shown by:\n\n * Have had 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, transcranial magnetic stimulation, or psychosurgery within the last year\n* Meet any other exclusion criteria per protocol"}, 'identificationModule': {'nctId': 'NCT01155661', 'briefTitle': 'A Safety Study in Participants With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Long-Term, Open-Label, Safety Study of LY2216684 12 to 18 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment', 'orgStudyIdInfo': {'id': '11318'}, 'secondaryIdInfos': [{'id': 'H9P-MC-LNBO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2216684 (edivoxetine) + SSRI', 'interventionNames': ['Drug: LY2216684 (edivoxetine)', 'Drug: SSRI']}], 'interventions': [{'name': 'LY2216684 (edivoxetine)', 'type': 'DRUG', 'otherNames': ['LY2216684', 'edivoxetine'], 'description': '12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)', 'armGroupLabels': ['LY2216684 (edivoxetine) + SSRI']}, {'name': 'SSRI', 'type': 'DRUG', 'otherNames': ['Selective Serotonin Reuptake Inhibitor'], 'description': 'Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study.', 'armGroupLabels': ['LY2216684 (edivoxetine) + SSRI']}]}, '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': '90703', 'city': 'Cerritos', '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': 33.85835, 'lon': -118.06479}}, {'zip': '92618', 'city': 'Irvine', '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': 33.66946, 'lon': -117.82311}}, {'zip': '90720', 'city': 'Los Alamitos', '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': 33.80307, 'lon': -118.07256}}, {'zip': '92374', 'city': 'Redlands', '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': 34.05557, 'lon': -117.18254}}, {'zip': '92506', 'city': 'Riverside', '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': 33.95335, 'lon': -117.39616}}, {'zip': '92121', 'city': 'San Diego', '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': 32.71571, 'lon': -117.16472}}, {'zip': '91786', 'city': 'Upland', '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': 34.09751, 'lon': -117.64839}}, {'zip': '32547', 'city': 'Fort Walton Beach', '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': 30.42059, 'lon': -86.61707}}, {'zip': '32607', 'city': 'Gainesville', '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': 29.65163, 'lon': -82.32483}}, {'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': '46260', 'city': 'Indianapolis', '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': 39.76838, 'lon': -86.15804}}, {'zip': '66206', 'city': 'Prairie Village', 'state': 'Kansas', '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': 38.99167, 'lon': -94.63357}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', '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': 42.35843, 'lon': -71.05977}}, {'zip': '08540', 'city': 'Princeton', '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': 40.34872, 'lon': -74.65905}}, {'zip': '87109', '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': '10549', 'city': 'Mount Kisco', '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': 41.20426, 'lon': -73.72708}}, {'zip': '10021', 'city': 'New York', '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': 40.71427, 'lon': -74.00597}}, {'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': '10467', 'city': 'The Bronx', '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': 40.84985, 'lon': -73.86641}}, {'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': '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}}, {'zip': '74922-810', 'city': 'Aparecida de Goiânia', 'country': 'Brazil', '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': -16.82333, 'lon': -49.24389}}, {'zip': '30210420', 'city': 'Belo Horizonte', 'country': 'Brazil', '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': -19.92083, 'lon': -43.93778}}, {'zip': '18618 970', 'city': 'Botucatu', 'country': 'Brazil', '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': -22.88583, 'lon': -48.445}}, {'zip': '96030-000', 'city': 'Pelotas', 'country': 'Brazil', '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': -31.76997, 'lon': -52.34101}}, {'zip': '14051-140', 'city': 'Ribeirão Preto', 'country': 'Brazil', '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': -21.1775, 'lon': -47.81028}}, {'zip': '22270060', 'city': 'Rio de Janeiro', 'country': 'Brazil', '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': -22.90642, 'lon': -43.18223}}, {'zip': '40301500', 'city': 'Salvador', 'country': 'Brazil', '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': -12.97563, 'lon': -38.49096}}, {'zip': '05403-010', 'city': 'São Paulo', 'country': 'Brazil', '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': -23.5475, 'lon': -46.63611}}, {'zip': '1270244', 'city': 'Antofagasta', 'country': 'Chile', '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': -23.65094, 'lon': -70.39752}}, {'zip': '7500710', 'city': 'Santiago', 'country': 'Chile', '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': -33.45694, 'lon': -70.64827}}, {'zip': 'LT-3005', 'city': 'Kaunas', 'country': 'Lithuania', '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': 54.90156, 'lon': 23.90909}}, {'zip': '91251', 'city': 'Klaipėda', 'country': 'Lithuania', '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': 55.7068, 'lon': 21.13912}}, {'zip': '37000', 'city': 'León', 'country': 'Mexico', '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': 25.60187, 'lon': -103.47698}}, {'zip': '82000', 'city': 'Mazatlán', 'country': 'Mexico', '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': 23.22163, 'lon': -106.41885}}, {'zip': '01030', 'city': 'Mexico City', 'country': 'Mexico', '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': 19.42847, 'lon': -99.12766}}, {'zip': '64040', 'city': 'Monterrey', 'country': 'Mexico', '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': 25.68435, 'lon': -100.31721}}, {'zip': '78250', 'city': 'San Luis Potosí City', 'country': 'Mexico', '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': 22.15234, 'lon': -100.97135}}, {'zip': '86035', 'city': 'Villahermosa', 'country': 'Mexico', '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': 17.98625, 'lon': -92.93928}}, {'zip': '45200', 'city': 'Zapopan', 'country': 'Mexico', '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': 20.72111, 'lon': -103.38742}}, {'zip': '8181 CX', 'city': 'Heerde', 'country': 'Netherlands', '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': 52.38723, 'lon': 6.04016}}, {'zip': '9648 BE', 'city': 'Wildervank', 'country': 'Netherlands', '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': 53.08083, 'lon': 6.8625}}, {'zip': '28806', 'city': 'Alcalá de Henares', 'country': 'Spain', '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': 40.48205, 'lon': -3.35996}}, {'zip': '28029', 'city': 'Madrid', 'country': 'Spain', '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': 40.4165, 'lon': -3.70256}}, {'zip': '49021', 'city': 'Zamora', 'country': 'Spain', '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': 41.50633, 'lon': -5.74456}}], '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'}}}}