Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-31 @ 7:13 PM
Study NCT ID:
NCT01421134
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2011-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069056', 'term': 'Lurasidone Hydrochloride'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialdisclosure@sunvion.com', 'phone': '1-866-503-6351', 'title': '1-866-503-6351', 'organization': 'Sunovion'}, 'certainAgreement': {'otherDetails': "There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed.\n\nIn addition to the \\<60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication provided, if a multicenter publication is not forthcoming within 24 months post completion of study at all sites, PI shall be free to publish.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Lurasidone', 'description': 'Lurasidone 20, 40 or 60 mg\n\nLurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks', 'otherNumAtRisk': 109, 'otherNumAffected': 31, 'seriousNumAtRisk': 109, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo', 'otherNumAtRisk': 100, 'otherNumAffected': 29, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnoelence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemarturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Depression Suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone', 'description': 'Lurasidone 20, 40 or 60 mg\n\nLurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.5', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-13.0', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.5', 'ciLowerLimit': '-10.2', 'ciUpperLimit': '-4.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.37', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone', 'description': 'Lurasidone 20, 40 or 60 mg\n\nLurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.83', 'spread': '0.109', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '0.115', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': "The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone', 'description': 'Lurasidone 20, 40 or 60 mg\n\nLurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.0', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '-1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone', 'description': 'Lurasidone 20, 40 or 60 mg\n\nLurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.2', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.8', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '-2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.21', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': "The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population: If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone', 'description': 'Lurasidone 20, 40 or 60 mg\n\nLurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.9', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.5', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '-2.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.81', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population. 3 Lurasidone subjects and 2 placebo subjects did not have post-baseline HAM-A assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone', 'description': 'Lurasidone 20, 40 or 60 mg\n\nLurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.615', 'ciLowerLimit': '3.251', 'ciUpperLimit': '13.459', 'estimateComment': 'Odds Ratio was based on a logistic regression of response, with treatment group, baseline MADRS total score, and pooled center as fixed effects.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 6', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone', 'description': 'Lurasidone 20, 40 or 60 mg\n\nLurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.270', 'ciLowerLimit': '2.105', 'ciUpperLimit': '8.663', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 6', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lurasidone', 'description': 'Lurasidone 20, 40 or 60 mg\n\nLurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lurasidone', 'description': 'Lurasidone 20, 40 or 60 mg\n\nLurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'spread': '12.08', 'groupId': 'BG000'}, {'value': '46.4', 'spread': '12.01', 'groupId': 'BG001'}, {'value': '44.9', 'spread': '12.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Two subjects were randomized in error and were not treated.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2011-08-17', 'resultsFirstSubmitDate': '2015-09-10', 'studyFirstSubmitQcDate': '2011-08-18', 'lastUpdatePostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-10', 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores', 'timeFrame': 'Baseline to Week 6', 'description': 'The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score', 'timeFrame': 'Baseline to Week 6', 'description': "The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity."}, {'measure': 'Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score', 'timeFrame': 'Baseline to Week 6', 'description': 'The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.'}, {'measure': 'Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score', 'timeFrame': 'Baseline to Week 6', 'description': "The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired)."}, {'measure': 'Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score', 'timeFrame': 'Baseline to Week 6', 'description': 'The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.'}, {'measure': 'Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).', 'timeFrame': 'Baseline to Week 6'}, {'measure': 'Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)', 'timeFrame': 'Baseline to Week 6'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['depression', 'Lurasidone', 'Latuda'], 'conditions': ['Major Depressive Disorder With Mixed Features']}, 'referencesModule': {'references': [{'pmid': '30086213', 'type': 'DERIVED', 'citation': 'Clayton AH, Tsai J, Mao Y, Pikalov A, Loebel A. Effect of Lurasidone on Sexual Function in Major Depressive Disorder Patients With Subthreshold Hypomanic Symptoms (Mixed Features): Results From a Placebo-Controlled Trial. J Clin Psychiatry. 2018 Aug 7;79(5):18m12132. doi: 10.4088/JCP.18m12132.'}, {'pmid': '29943445', 'type': 'DERIVED', 'citation': 'Targum SD, Pendergrass JC, Lee S, Loebel A. Ratings surveillance and reliability in a study of major depressive disorder with subthreshold hypomania (mixed features). Int J Methods Psychiatr Res. 2018 Dec;27(4):e1729. doi: 10.1002/mpr.1729. Epub 2018 Jun 26.'}, {'pmid': '26908089', 'type': 'DERIVED', 'citation': 'Targum SD, Suppes T, Pendergrass JC, Lee S, Silva R, Cucchiaro J, Loebel A. Major depressive disorder with subthreshold hypomania (mixed features): Clinical characteristics of patients entered in a multiregional, placebo-controlled study. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jul 4;68:9-14. doi: 10.1016/j.pnpbp.2016.02.007. Epub 2016 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.\n* Subject is 18 to 75 years of age, inclusive.\n* Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version \\[SCID-CT\\]).\n* Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):\n\n * Elevated, expansive mood\n * Inflated self-esteem or grandiosity\n * More talkative than usual or pressure to keep talking\n * Flight of ideas or subjective experience that thoughts are racing\n * Increase in energy or goal-directed activity (either socially, at work or school, or sexually)\n * Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)\n * Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia)\n\nExclusion Criteria:\n\n* Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.\n* Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.\n* Subject has attempted suicide within the past 3 months.\n* Subject has a lifetime history of any bipolar I manic or mixed manic episode.\n* Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.'}, 'identificationModule': {'nctId': 'NCT01421134', 'acronym': 'RESOLVE 1', 'briefTitle': 'Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': 'A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features', 'orgStudyIdInfo': {'id': 'D1050304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lurasidone', 'description': 'Lurasidone 20, 40 or 60 mg', 'interventionNames': ['Drug: Lurasidone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lurasidone', 'type': 'DRUG', 'otherNames': ['Latuda'], 'description': '20, 40, 60 mg, flexible dose, once daily PM 6 weeks', 'armGroupLabels': ['Lurasidone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35226', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Psychiatry Pharmaceutical Studies, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Clinical Research Center', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network Inc.', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford -VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Innovations Inc.', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '34201', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center, LLC', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Charles Psychiatric Associates/Midwest Research Group', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '11235', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Social Psychiatric Research Inst. 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