Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-03-28 @ 2:39 PM
Study NCT ID:
NCT02002832
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2013-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Trial of Lurasidone in Treatment of Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}, {'id': 'D018967', 'term': 'Risperidone'}], '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'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'luo@dsmpharm.com.cn', 'phone': '+86-10-57322070', 'title': 'Chief Medical Officer', 'organization': 'Sumitomo Pharma (Suzhou) Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.', 'description': 'Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.', 'eventGroups': [{'id': 'EG000', 'title': 'Lurasidone Group', 'description': 'Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day.', 'otherNumAtRisk': 194, 'deathsNumAtRisk': 194, 'otherNumAffected': 134, 'seriousNumAtRisk': 194, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Risperidone Group', 'description': 'Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.', 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 160, 'seriousNumAtRisk': 191, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 73}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Poor quality sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Hypertonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Consitpation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Affect lability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Blood prolactin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}, {'term': 'Hyperprolactinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}], 'seriousEvents': [{'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(16.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone Group', 'description': 'Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day.'}, {'id': 'OG001', 'title': 'Risperidone Group', 'description': 'Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.2', 'groupId': 'OG000', 'lowerLimit': '-33.2', 'upperLimit': '-29.2'}, {'value': '-34.9', 'groupId': 'OG001', 'lowerLimit': '-36.8', 'upperLimit': '-32.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '1.0', 'ciUpperLimit': '6.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.37', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'LS mean for the treatment difference(lurasidone-risperidone) at week 6 and its 95% confidence interval was presented based on the MMRM. Non-inferiority for lurasidone relative to risperidone was evaluated by comparing the upper bound of the 95% confidence interval to the non-inferiority margin of 7.0. Plots of estimates for change from baseline in PANSS total score based on MMRM over time (Week 1 to Week 6) with 95% confidence intervals was provided for each treatment group.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 6(day 42).', 'description': 'Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 6 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores\\<70 is the normal,but the scores\\>120 is more serious.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat 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.'}, {'type': 'SECONDARY', 'title': 'Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lurasidone Group', 'description': 'Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day'}, {'id': 'OG001', 'title': 'Risperidone Group', 'description': 'Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '2.1'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 6(day 42).', 'description': "The Clinical Global Impression Scale-Improvement (CGI-I) Score is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to baseline state at the beginning of the intervention. Response is rated as one of the following, in which higher scores indicate less improvement or worsening:\n\n1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.", 'unitOfMeasure': 'units 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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lurasidone Group', 'description': 'Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day'}, {'id': 'FG001', 'title': 'Risperidone Group', 'description': 'Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '194'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '168'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lurasidone Group', 'description': 'Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day'}, {'id': 'BG001', 'title': 'Risperidone Group', 'description': 'Risperidone 2-6mg taken orally once a day and Lurasidone placebo tablets taken orally once a day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'spread': '11.12', 'groupId': 'BG000'}, {'value': '34.8', 'spread': '10.71', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '10.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-to-treat population (ITT) : All randomized subjects who received at least one dose of study medication,were included in the Intent-to-treat population.'}}, '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': 388}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-03', 'studyFirstSubmitDate': '2013-12-02', 'resultsFirstSubmitDate': '2018-05-31', 'studyFirstSubmitQcDate': '2013-12-02', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-26', 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.', 'timeFrame': 'From baseline to Week 6(day 42).', 'description': 'Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 6 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores\\<70 is the normal,but the scores\\>120 is more serious.'}], 'secondaryOutcomes': [{'measure': 'Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.', 'timeFrame': 'From baseline to Week 6(day 42).', 'description': "The Clinical Global Impression Scale-Improvement (CGI-I) Score is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to baseline state at the beginning of the intervention. Response is rated as one of the following, in which higher scores indicate less improvement or worsening:\n\n1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'Lurasidone', 'LATUDA'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose, non-inferiority and multicentre study designed to evaluate the efficacy and safety of lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide written informed consent and aged between 18 and 65 years of age.\n* Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at Screening and Baseline.\n* Not pregnant, if of reproductive potential agrees to 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* 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* Subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form.\n* Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT02002832', 'briefTitle': 'A Clinical Trial of Lurasidone in Treatment of Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma (Suzhou) Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Double-dummy, Parallel-group and Multicenter Study to Investigate Lurasidone in Treatment of Schizophrenia Compared With Risperidone', 'orgStudyIdInfo': {'id': 'D1070004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lurasidone group', 'interventionNames': ['Drug: Lurasidone tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Risperidone group', 'interventionNames': ['Drug: Risperidone tablets']}], 'interventions': [{'name': 'Lurasidone tablets', 'type': 'DRUG', 'otherNames': ['LATUDA'], 'description': 'Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)', 'armGroupLabels': ['Lurasidone group']}, {'name': 'Risperidone tablets', 'type': 'DRUG', 'description': 'Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)', 'armGroupLabels': ['Risperidone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100088', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Capital Medical University Affiliated Beijing Anding Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100096', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Huilongguan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Sixth Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510370', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Brain Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '071000', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': 'HeBei Mental Health 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