Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-01 @ 5:00 PM
Study NCT ID:
NCT02600494
Status:
COMPLETED
Last Update Posted:
2025-11-03
First Post:
2015-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000705749', 'term': 'lumateperone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ITCIClinicalTrials@itci-inc.com', 'phone': '646-440-9333', 'title': 'Vice President, Clinical Development', 'organization': 'Intra-Cellular Therapies, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate)', 'description': 'Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks\n\nITI-007 (Lumateperone)', 'otherNumAtRisk': 180, 'deathsNumAtRisk': 180, 'otherNumAffected': 72, 'seriousNumAtRisk': 180, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks\n\nLumateperone (ITI-007)', 'otherNumAtRisk': 184, 'deathsNumAtRisk': 184, 'otherNumAffected': 67, 'seriousNumAtRisk': 184, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A Placebo', 'description': 'Placebo administered orally as visually-matched capsules once daily for 6 weeks\n\nPlacebo', 'otherNumAtRisk': 185, 'deathsNumAtRisk': 185, 'otherNumAffected': 31, 'seriousNumAtRisk': 185, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for up to 6 months\n\nLumateperone (ITI-007)', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 55, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Panic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Agression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Anemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Procedural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumateperone 28 mg (ITI-007 40 mg Tosylate)', 'description': 'Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks\n\nITI-007 (Lumateperone)'}, {'id': 'OG001', 'title': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks\n\nLumateperone (ITI-007)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally as visually-matched capsules once daily for 6 weeks\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.9', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-20.7', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '-19.7', 'spread': '1.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.514', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-1.83', 'ciUpperLimit': '3.53', 'pValueComment': 'p-value is Hochberg-adjusted', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.895', 'groupIds': ['OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-3.73', 'ciUpperLimit': '1.79', 'pValueComment': 'p-value is Hochberg adjusted', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Set contains all randomized patients who received at least one dose of study medication and who had a valid baseline (pre-dose) measurement and at least one valid post-baseline measurement of MADRS total score.'}, {'type': 'SECONDARY', 'title': 'Time to First Sustained Response in Reduction of MADRS Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumateperone 28 mg (ITI-007 40 mg Tosylate)', 'description': 'Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks\n\nITI-007 (Lumateperone)'}, {'id': 'OG001', 'title': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks\n\nLumateperone (ITI-007)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally as visually-matched capsules once daily for 6 weeks\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'comment': 'Upper limit of the confidence interval could not be calculated due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': 'NA'}, {'value': '38', 'comment': 'Upper limit of the confidence interval could not be calculated due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': 'NA'}, {'value': '37', 'comment': 'Upper limit of the confidence interval could not be calculated due to insufficient number of events.', 'groupId': 'OG002', 'lowerLimit': '30', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.993', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.712', 'ciUpperLimit': '1.400', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.665', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.657', 'ciUpperLimit': '1.307', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline to Day 175 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for approximately 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.9', 'spread': '10.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 175', 'description': 'The MADRS total score from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set - all patients who received at least 1 dose of study medication in Part B'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for approximately 6 months'}], 'classes': [{'title': 'Headache', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Dry Mouth', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Somnolence', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 175', 'description': 'Incidence of Treatment-Emergent Adverse Events from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lumateperone 28 mg (ITI-007 40 mg Tosylate)', 'description': 'Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks\n\nITI-007 (Lumateperone)'}, {'id': 'FG001', 'title': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks\n\nLumateperone (ITI-007)'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo administered orally as visually-matched capsules once daily for 6 weeks\n\nPlacebo'}], 'periods': [{'title': 'Part A (6 Week Double-Blind Treatment)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '185'}, {'groupId': 'FG002', 'numSubjects': '186'}]}, {'type': 'Number of Patients Randomized and Took at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '184'}, {'groupId': 'FG002', 'numSubjects': '185'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'non-compliant with site request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part B (6 Month Open-Label Treatment)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'This was an open label portion of the study where all pts received Lumateperone 42 mg/day; therefore, the Lumateperone 28 mg and Placebo arms are not applicable.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'For some patients Part B was not a direct rollover; therefore, the number of patients that completed Part A does not equal the number of patients enrolled in Part B.', 'groupId': 'FG001', 'numSubjects': '127'}, {'comment': 'This was an open label portion of the study where all pts received Lumateperone 42 mg/day; therefore, the Lumateperone 28 mg and Placebo arms are not applicable.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Part A includes all patients who signed the informed consent and were randomized in to the 6 week double-blind treatment period. 554 patients were randomized; 549 patients received study drug and are included in the safety population.\n\nPart B includes all patients who signed the informed consent and received open-label study drug for up to 6 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '549', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lumateperone 28 mg (ITI-007 40 mg Tosylate)', 'description': 'Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks\n\nITI-007 (Lumateperone)'}, {'id': 'BG001', 'title': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks\n\nLumateperone (ITI-007)'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo administered orally as visually-matched capsules once daily for 6 weeks\n\nPlacebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'spread': '12.12', 'groupId': 'BG000'}, {'value': '42.7', 'spread': '11.85', 'groupId': 'BG001'}, {'value': '42.3', 'spread': '13.13', 'groupId': 'BG002'}, {'value': '41.9', 'spread': '12.40', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '334', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '215', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '304', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Montgomery Asberg Depression Rating Scale (MADRS)', 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'spread': '6.08', 'groupId': 'BG000'}, {'value': '35.9', 'spread': '5.79', 'groupId': 'BG001'}, {'value': '34.7', 'spread': 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