Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT00615433
Status:
COMPLETED
Last Update Posted:
2015-06-12
First Post:
2008-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
Sponsor:
Organization:
Raw JSON
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One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '123'}, {'groupId': 'FG003', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '45'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '475', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '40mg', 'description': 'Lurasidone 40 mg tablet taken orally once a day. 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One subject who was randomized to the 120 mg treatment group did not take any study medication.'}, {'id': 'BG002', 'title': '15mg Olz', 'description': '3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '37.9', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '38.3', 'spread': '10.2', 'groupId': 'BG002'}, {'value': '36.9', 'spread': '11.3', 'groupId': 'BG003'}, {'value': '37.7', 'spread': '10.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}, {'value': '371', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '284', 'groupId': 'BG004'}]}]}, {'title': 'Philippines', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 478}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2008-02-01', 'resultsFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2008-02-13', 'lastUpdatePostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-17', 'studyFirstPostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.'}], 'secondaryOutcomes': [{'measure': 'CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.', 'timeFrame': '6 weeks', 'description': "The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Latuda', 'Lurasidone'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '21676992', 'type': 'BACKGROUND', 'citation': 'Meltzer HY, Cucchiaro J, Silva R, Ogasa M, Phillips D, Xu J, Kalali AH, Schweizer E, Pikalov A, Loebel A. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study. Am J Psychiatry. 2011 Sep;168(9):957-67. doi: 10.1176/appi.ajp.2011.10060907. Epub 2011 Jun 15.'}, {'pmid': '23541189', 'type': 'RESULT', 'citation': 'Stahl SM, Cucchiaro J, Simonelli D, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study. J Clin Psychiatry. 2013 May;74(5):507-15. doi: 10.4088/JCP.12m08084. Epub 2013 Mar 13.'}, {'pmid': '39144777', 'type': 'DERIVED', 'citation': 'Hopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan.'}, {'pmid': '34751928', 'type': 'DERIVED', 'citation': 'Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.'}, {'pmid': '24955752', 'type': 'DERIVED', 'citation': 'Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide written informed consent and aged between 18 and 75 years of age.\n* Meets DSM-IV criteria for a primary diagnosis of schizophrenia.\n* Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.\n* Able and agrees to remain off prior antipsychotic medication for the duration of study.\n* Good physical health on the basis of medical history, physical examination, and laboratory screening.\n* Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.\n\nExclusion Criteria:\n\n* Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.\n* Any chronic organic disease of the CNS (other than schizophrenia).\n* Used investigational compound within 30 days.\n* Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months'}, 'identificationModule': {'nctId': 'NCT00615433', 'briefTitle': 'Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': 'A Phase 3 Randomized, Placebo-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.', 'orgStudyIdInfo': {'id': 'D1050231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lurasdione 40mg tablets', 'interventionNames': ['Drug: Lurasidone 40 mg tablets']}, {'type': 'EXPERIMENTAL', 'label': '120mg', 'interventionNames': ['Drug: Lurasidone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '15mg Olz', 'interventionNames': ['Drug: Olanzapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'interventionNames': ['Drug: Placebo comparator']}], 'interventions': [{'name': 'Lurasidone', 'type': 'DRUG', 'description': '120mg/day', 'armGroupLabels': ['120mg']}, {'name': 'Olanzapine', 'type': 'DRUG', 'description': '15mg/day', 'armGroupLabels': ['15mg Olz']}, {'name': 'Placebo comparator', 'type': 'DRUG', 'description': 'Placebor Comparator', 'armGroupLabels': ['Sugar pill']}, {'name': 'Lurasidone 40 mg tablets', 'type': 'DRUG', 'description': 'Lurasidone 40 mg tablets', 'armGroupLabels': ['Lurasdione 40mg tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72201', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'K&S Professional Research Services LLC', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Woodland International Research Group, LLC', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Pharmacological Studies, Inc.', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Excell Research', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90723', 'city': 'Paramount', 'state': 'California', 'country': 'United States', 'facility': 'California Clinical Trials', 'geoPoint': {'lat': 33.88946, 'lon': -118.15979}}, {'zip': '92102', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'CNRI - 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