Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-29 @ 7:12 AM
Study NCT ID:
NCT00790192
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2008-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'josephine.cucchiaro@sunovion.com', 'phone': '201-592-2050', 'title': 'Josephine Cucchiaro, PhD, Executive Director', 'organization': 'Sunovion'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '14 days post study therapy', 'eventGroups': [{'id': 'EG000', 'title': 'Lurasidone 80 mg', 'description': 'Lurasidone 80 mg tablets taken orally once a day', 'otherNumAtRisk': 125, 'otherNumAffected': 71, 'seriousNumAtRisk': 125, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Lurasidone 160 mg', 'description': 'Lurasidone 160 mg (4 tablets) taken orally once a day', 'otherNumAtRisk': 121, 'otherNumAffected': 76, 'seriousNumAtRisk': 121, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Quetiapine XR 600mg', 'description': 'Quetiapine XR 600 mg (4 tablets) orally taken once a day', 'otherNumAtRisk': 119, 'otherNumAffected': 70, 'seriousNumAtRisk': 119, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \\>= 5%.', 'otherNumAtRisk': 121, 'otherNumAffected': 69, 'seriousNumAtRisk': 121, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Left Ventricular Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Hernia Obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatitis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Agression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyschotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal Behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Physical Assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Labile Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone 80 mg', 'description': 'Lurasidone 80 mg tablets taken orally once a day'}, {'id': 'OG001', 'title': 'Lurasidone 160 mg', 'description': 'Lurasidone 160 mg (4 tablets) taken orally once a day'}, {'id': 'OG002', 'title': 'Quetiapine XR 600mg', 'description': 'Quetiapine XR 600 mg (4 tablets) orally taken once a day'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \\>= 5%.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.2', 'groupId': 'OG000', 'lowerLimit': '-25.7', 'upperLimit': '-18.7'}, {'value': '-26.5', 'groupId': 'OG001', 'lowerLimit': '-30.0', 'upperLimit': '-23.0'}, {'value': '-27.8', 'groupId': 'OG002', 'lowerLimit': '-31.3', 'upperLimit': '-24.2'}, {'value': '-10.3', 'groupId': 'OG003', 'lowerLimit': '-13.9', 'upperLimit': '-6.7'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6', 'description': 'The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.', 'anticipatedPostingDate': '2011-09'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone 80 mg', 'description': 'Lurasidone 80 mg tablets taken orally once a day'}, {'id': 'OG001', 'title': 'Lurasidone 160 mg', 'description': 'Lurasidone 160 mg (4 tablets) taken orally once a day'}, {'id': 'OG002', 'title': 'Quetiapine XR 600mg', 'description': 'Quetiapine XR 600 mg (4 tablets) orally taken once a day'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \\>= 5%.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '-1.3'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '-1.5'}, {'value': '-1.7', 'groupId': 'OG002', 'lowerLimit': '-1.9', 'upperLimit': '-1.5'}, {'value': '-0.9', 'groupId': 'OG003', 'lowerLimit': '-1.1', 'upperLimit': '-0.7'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6-Weeks', 'description': "Clinical Global Impression of Severity 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. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).", 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-09'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lurasidone 80 mg', 'description': 'Lurasidone 80 mg tablets taken orally once a day'}, {'id': 'FG001', 'title': 'Lurasidone 160 mg', 'description': 'Lurasidone 160 mg (4 tablets) taken orally once a day'}, {'id': 'FG002', 'title': 'Quetiapine XR 600mg', 'description': 'Quetiapine XR 600 mg (4 tablets) orally taken once a day'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \\>= 5%.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '97'}, {'groupId': 'FG003', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '48'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}, {'value': '488', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Lurasidone 80 mg', 'description': 'Lurasidone 80 mg tablets taken orally once a day'}, {'id': 'BG001', 'title': 'Lurasidone 160 mg', 'description': 'Lurasidone 160 mg (4 tablets) taken orally once a day'}, {'id': 'BG002', 'title': 'Quetiapine XR 600mg', 'description': 'Quetiapine XR 600 mg (4 tablets) orally taken once a day'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \\>= 5%.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '37.9', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '37.4', 'spread': '10.4', 'groupId': 'BG002'}, {'value': '37.4', 'spread': '10.8', 'groupId': 'BG003'}, {'value': '37.2', 'spread': '10.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '154', 'groupId': 'BG004'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '332', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'There were two subjects, one randomized to the Quetiapine 600 mg group and one subject randomized to placebo that did not take study drug. Thus you see a discrepancy between the participant population and the overall baseline population for the two treatment groups (1 less patient in each treatment arm).', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '151', 'groupId': 'BG004'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'There were two subjects, one randomized to the Quetiapine 600 mg group and one subject randomized to placebo that did not take study drug. Thus you see a discrepancy between the participant population and the overall baseline population(1 less patient in each treatment arm).', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 488}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-11', 'studyFirstSubmitDate': '2008-11-10', 'resultsFirstSubmitDate': '2011-09-01', 'studyFirstSubmitQcDate': '2008-11-12', 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-01', 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase', 'timeFrame': 'Week 6', 'description': 'The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment', 'timeFrame': '6-Weeks', 'description': "Clinical Global Impression of Severity 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. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'SM-13496', 'Latuda', 'Lurasidone'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '23415311', 'type': 'RESULT', 'citation': 'Loebel A, Cucchiaro J, Sarma K, Xu L, Hsu C, Kalali AH, Pikalov A, Potkin SG. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. Schizophr Res. 2013 Apr;145(1-3):101-9. doi: 10.1016/j.schres.2013.01.009. Epub 2013 Feb 13.'}, {'pmid': '24035633', 'type': 'RESULT', 'citation': 'Harvey PD, Siu CO, Hsu J, Cucchiaro J, Maruff P, Loebel A. Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension. Eur Neuropsychopharmacol. 2013 Nov;23(11):1373-82. doi: 10.1016/j.euroneuro.2013.08.003. Epub 2013 Aug 27.'}, {'pmid': '24330860', 'type': 'RESULT', 'citation': 'Loebel AD, Siu CO, Cucchiaro JB, Pikalov AA, Harvey PD. Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia. CNS Spectr. 2014 Apr;19(2):197-205. doi: 10.1017/S1092852913000904. Epub 2013 Dec 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': '26117157', 'type': 'DERIVED', 'citation': 'Harvey PD, Siu CO, Ogasa M, Loebel A. Effect of lurasidone dose on cognition in patients with schizophrenia: post-hoc analysis of a long-term, double-blind continuation study. Schizophr Res. 2015 Aug;166(1-3):334-8. doi: 10.1016/j.schres.2015.06.008. Epub 2015 Jun 24.'}, {'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 being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.'}, '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': 'NCT00790192', 'acronym': 'PEARL 3', 'briefTitle': 'Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': 'A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)', 'orgStudyIdInfo': {'id': 'D1050233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lurasidone 80mg', 'interventionNames': ['Drug: Lurasidone']}, {'type': 'EXPERIMENTAL', 'label': 'Lurasidone 160mg', 'interventionNames': ['Drug: Lurasidone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quetiapine XR', 'interventionNames': ['Drug: Quetiapine XR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lurasidone', 'type': 'DRUG', 'description': 'Lurasidone 80 mg tablets', 'armGroupLabels': ['Lurasidone 80mg']}, {'name': 'Lurasidone', 'type': 'DRUG', 'description': 'Lurasidone 4 40 mg tablets', 'armGroupLabels': ['Lurasidone 160mg']}, {'name': 'Quetiapine XR', 'type': 'DRUG', 'description': 'Quetiapine XR 600mg', 'armGroupLabels': ['Quetiapine XR']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching Placebo to Lurasidone or Quetiapine', 'armGroupLabels': ['Placebo']}]}, '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', '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': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Neuroscience, Inc', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '92647', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Innovations, Inc.', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Escondido', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '92645', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Apostle Clinical Trials, Inc.', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90723', 'city': 'Paramount', 'state': 'California', 'country': 'United States', 'facility': 'California Clinical Trials', 'geoPoint': {'lat': 33.88946, 'lon': -118.15979}}, {'zip': '91107', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Pasadena Research Institute', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '90660', 'city': 'Pico Rivera', 'state': 'California', 'country': 'United States', 'facility': 'CNRI-Los Angeles. 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