Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-14 @ 6:27 PM
Study NCT ID:
NCT02282761
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2014-10-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial to Assess the Antipsychotic Efficacy of ITI-007
Sponsor:
Organization:
Raw JSON
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administered orally as formulated capsules once daily for 28 days\n\nITI-007', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 55, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days\n\nITI-007', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 70, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo administered orally as formulated capsules once daily for 28 days\n\nPlacebo', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 41, 'seriousNumAtRisk': 149, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'seriousEvents': [{'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '141', '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 formulated capsules once daily for 28 days\n\nITI-007'}, {'id': 'OG001', 'title': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days\n\nITI-007'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally as formulated capsules once daily for 28 days\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.9', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-14.5', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '-10.3', 'spread': '1.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.182', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-6.17', 'ciUpperLimit': '1.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.83', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.045', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-7.75', 'ciUpperLimit': '-0.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.82', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '141', '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 formulated capsules once daily for 28 days\n\nITI-007'}, {'id': 'OG001', 'title': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days\n\nITI-007'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally as formulated capsules once daily for 28 days\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '-0.12', 'statisticalMethod': 'Mixed Effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'The Clinical Global Impressions (CGI) Scale is a standardized assessment tool that the clinician can use to rate the severity of illness, change over time, and efficacy of medication, taking into account the subject\'s clinical condition and the severity of side effects. The CGI Scale consists of 3 global subscales, only one of which was used in the present study. The first subscale, Severity of Illness (CGI-S), assesses the clinician\'s impression of the subject\'s current illness state; it is often used both before and after treatment. Scores on the Severity of Illness subscale range from 1 = "not ill" at all to 7 = "among the most extremely ill."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', '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 formulated capsules once daily for 28 days\n\nITI-007'}, {'id': 'FG001', 'title': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days\n\nITI-007'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo administered orally as formulated capsules once daily for 28 days\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'comment': '150 patients were randomized to the placebo treatment group but only 149 patients took study drug. The number completed and discontinued is based on the 149 patients that took study drug.', 'groupId': 'FG002', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '449', '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 formulated capsules once daily for 28 days\n\nITI-007'}, {'id': 'BG001', 'title': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days\n\nITI-007'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo administered orally as formulated capsules once daily for 28 days\n\nPlacebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '10.08', 'groupId': 'BG000'}, {'value': '42.4', 'spread': '10.30', 'groupId': 'BG001'}, {'value': '41.4', 'spread': '10.29', 'groupId': 'BG002'}, {'value': '42.4', 'spread': '10.23', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '346', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '298', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Positive and Negative Syndrome Scale (PANSS) total score', 'classes': [{'categories': [{'measurements': [{'value': '89.2', 'spread': '10.13', 'groupId': 'BG000'}, {'value': '90.2', 'spread': '9.58', 'groupId': 'BG001'}, {'value': '90.6', 'spread': '11.26', 'groupId': 'BG002'}, {'value': '90.0', 'spread': '10.34', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, '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': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2017-03-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2014-10-31', 'dispFirstSubmitQcDate': '2017-03-09', 'resultsFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2014-11-03', 'dispFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-16', 'studyFirstPostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score', 'timeFrame': '28 days', 'description': 'The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale', 'timeFrame': '28 days', 'description': 'The Clinical Global Impressions (CGI) Scale is a standardized assessment tool that the clinician can use to rate the severity of illness, change over time, and efficacy of medication, taking into account the subject\'s clinical condition and the severity of side effects. The CGI Scale consists of 3 global subscales, only one of which was used in the present study. The first subscale, Severity of Illness (CGI-S), assesses the clinician\'s impression of the subject\'s current illness state; it is often used both before and after treatment. Scores on the Severity of Illness subscale range from 1 = "not ill" at all to 7 = "among the most extremely ill."'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '36883881', 'type': 'DERIVED', 'citation': 'Citrome L, Durgam S, Edwards JB, Davis RE. Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Mar 6;84(2):22r14631. doi: 10.4088/JCP.22r14631.'}, {'pmid': '31913424', 'type': 'DERIVED', 'citation': "Correll CU, Davis RE, Weingart M, Saillard J, O'Gorman C, Kane JM, Lieberman JA, Tamminga CA, Mates S, Vanover KE. Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Apr 1;77(4):349-358. doi: 10.1001/jamapsychiatry.2019.4379."}]}, 'descriptionModule': {'briefSummary': 'The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia\n* experiencing an acute exacerbation of psychosis\n\nExclusion Criteria:\n\n* any subject unable to provide informed consent\n* any female subject who is pregnant or breast-feeding\n* any subject judged to be medically inappropriate for study participation'}, 'identificationModule': {'nctId': 'NCT02282761', 'briefTitle': 'A Trial to Assess the Antipsychotic Efficacy of ITI-007', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intra-Cellular Therapies, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'ITI-007-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lumateperone 28 mg (ITI-007 40 mg Tosylate)', 'description': 'Lumateperone 28 mg (ITI-007 40 mg Tosylate) administered orally as formulated capsules once daily for 28 days', 'interventionNames': ['Drug: ITI-007']}, {'type': 'EXPERIMENTAL', 'label': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)', 'description': 'Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days', 'interventionNames': ['Drug: ITI-007']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered orally as formulated capsules once daily for 28 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ITI-007', 'type': 'DRUG', 'armGroupLabels': ['Lumateperone 28 mg (ITI-007 40 mg Tosylate)', 'Lumateperone 42 mg (ITI-007 60 mg Tosylate)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Kimberly Vanover, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Intra-Cellular Therapies, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intra-Cellular Therapies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}