{ "FullStudy":{ "Rank":217819, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516424", "OrgStudyIdInfo":{ "OrgStudyId":"D4906011" }, "Organization":{ "OrgFullName":"Sumitomo Pharmaceutical (Suzhou) Co., Ltd.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone", "OfficialTitle":"A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone" }, "StatusModule":{ "StatusVerifiedDate":"May 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"February 12, 2015", "ResultsFirstSubmitQCDate":"May 10, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"November 26, 2018", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"November 25, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 27, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Sumitomo Pharmaceutical (Suzhou) Co., Ltd.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone", "DetailedDescription":"A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone\n\nTrial drugs:\n\nBlonanserin group: Blonanserin tablets+Risperidone mimetic tablets\nRisperidone group: Risperidone tablets+Blonanserin mimetic tablets\n\nObjectives of Study :\n\nTo evaluate the efficacy and safety of Blonanserin in treating schizophrenia" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Schizophrenia" ] }, "KeywordList":{ "Keyword":[ "Blonanserin" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"267", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Blonanserin", "ArmGroupType":"Experimental", "ArmGroupDescription":"Antipsychotics", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Blonanserin" ] } },{ "ArmGroupLabel":"Risperidone", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Antipsychotics", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Risperidone" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Blonanserin", "InterventionDescription":"Blonanserin tablets: 8 - 24mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Blonanserin" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Lonasen" ] } },{ "InterventionType":"Drug", "InterventionName":"Risperidone", "InterventionDescription":"Risperidone tablets: 2 - 6mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Risperidone" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Risperdal" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8", "PrimaryOutcomeDescription":"Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 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.Change=(Week 8 Score - Baseline score)", "PrimaryOutcomeTimeFrame":"From baseline to the end of study、week 8(day 56)or before other antipsychotic taken." } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Mean Change in PANSS Subscale Score at the End of Treatment", "SecondaryOutcomeDescription":"Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline", "SecondaryOutcomeTimeFrame":"week 8" },{ "SecondaryOutcomeMeasure":"Mean Change in PANSS 5-factor Model", "SecondaryOutcomeDescription":"Mean change in PANSS 5-factor model from baseline at Week 8", "SecondaryOutcomeTimeFrame":"Week 8" },{ "SecondaryOutcomeMeasure":"Mean Change in PANSS Symptom Scores", "SecondaryOutcomeDescription":"Mean change in PANSS symptom scores from baseline at Week 8", "SecondaryOutcomeTimeFrame":"Week 8" },{ "SecondaryOutcomeMeasure":"Mean Change in PANSS Symptom Scores From Baseline at Each Visit", "SecondaryOutcomeDescription":"Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8", "SecondaryOutcomeTimeFrame":"Each Visit" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text Revision(TR) criteria for a primary diagnosis of schizophrenia\nPatients are 18≤age＜65 years of age on the day when informed consent is obtained.\nSubject had a PANSS total score ≥70 and 120≥ at Screening\nSubject had a score ≥4 on the PANSS at Screening and Baseline.\nSubjects are willing and able to comply with study protocol including treatment in hospital.\nSubjects or their legal guardians have signed the written informed consent form.\n\nExclusion Criteria:\n\nThe subject was treatment with other Investigate product within 30 days.\nSubject had a history of treatment with long-acting drug for anti schizophrenia within 56 days.\nSubject had a history of treatment with clozapine within 28 days.\nSubject With parkinson disease,etc", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"64 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Niufan Gu, MD", "OverallOfficialAffiliation":"Shanghai Mental Health Center", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Beijing Anding Hospital", "LocationCity":"Beijing", "LocationState":"Beijing", "LocationZip":"100088", "LocationCountry":"China" },{ "LocationFacility":"Beijing Huilongguan Hospital", "LocationCity":"Beijing", "LocationState":"Beijing", "LocationZip":"100096", "LocationCountry":"China" },{ "LocationFacility":"Peking University Sixth Hospital", "LocationCity":"Beijing", "LocationState":"Beijing", "LocationZip":"100191", "LocationCountry":"China" },{ "LocationFacility":"Guangzhou Brain Hospital", "LocationCity":"Guangzhou", "LocationState":"Guangdong", "LocationZip":"510170", "LocationCountry":"China" },{ "LocationFacility":"Hebei Province Mental Health Center", "LocationCity":"Baoding", "LocationState":"Hebei", "LocationZip":"071000", "LocationCountry":"China" },{ "LocationFacility":"The First Affiliated Hospital of Harbin Medical University", "LocationCity":"Harbin", "LocationState":"Heilongjiang", "LocationZip":"150001", "LocationCountry":"China" },{ "LocationFacility":"Henan Provincial Mental Hospital", "LocationCity":"Xinxiang", "LocationState":"Henan", "LocationZip":"453002", "LocationCountry":"China" },{ "LocationFacility":"The Second Xiangya Hospital of Central South University", "LocationCity":"Changsha", "LocationState":"Hunan", "LocationZip":"410000", "LocationCountry":"China" },{ "LocationFacility":"Hunan Province Brain Hospital", "LocationCity":"Changsha", "LocationState":"Hunan", "LocationZip":"410007", "LocationCountry":"China" },{ "LocationFacility":"Nanjing Brain Hospital", "LocationCity":"Nanjing", "LocationState":"Jiangsu", "LocationZip":"210029", "LocationCountry":"China" },{ "LocationFacility":"Wuxi Mental Health Center", "LocationCity":"Wuxi", "LocationState":"Jiangsu", "LocationZip":"214000", "LocationCountry":"China" },{ "LocationFacility":"Shanghai Mental Health Center", "LocationCity":"Shang Hai", "LocationState":"Shanghai", "LocationZip":"200030", "LocationCountry":"China" },{ "LocationFacility":"Xi'an Mental Health Center", "LocationCity":"Xi'an", "LocationState":"Shanxi", "LocationZip":"710061", "LocationCountry":"China" },{ "LocationFacility":"West China Hospital, Sichuan University", "LocationCity":"Chengdu", "LocationState":"Sichuan", "LocationZip":"610041", "LocationCountry":"China" },{ "LocationFacility":"Tianjin Anding Hospital", "LocationCity":"Tianjin", "LocationState":"Tianjin", "LocationZip":"300222", "LocationCountry":"China" },{ "LocationFacility":"First Affiliated Hospital of Kunming Medical University", "LocationCity":"Kun Ming", "LocationState":"Yunnan", "LocationZip":"650032", "LocationCountry":"China" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Blonanserin", "FlowGroupDescription":"Blonanserin:\n\nDosage Form: Tablet Dosage and Usage: 8~24mg/d ,b.i.d" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Risperidone", "FlowGroupDescription":"Risperidone:\n\nDosage Form: Tablet Dosage and Usage: 2~6mg/d ,b.i.d" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"the patient number of randomization for Blonanserin Group", "FlowAchievementNumSubjects":"131" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"the patient number of randomization for Risperidone Group", "FlowAchievementNumSubjects":"136" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"96" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"114" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"35" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"22" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"267 subjects in participant flow, 3 subjects randomized and not treated, 2 subjects does not have baseline PANSS scale, 1 subject take Blonanserin, which IWRS's indicate he should take Risperidone and no PANSS scale collectted after first dose. Those 6 subjects excluded from Baseline Population. The Baseline population have 261 subjects.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Blonanserin", "BaselineGroupDescription":"Participants received 8-24mg tablet orally twice daily for 8 weeks" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Risperidone", "BaselineGroupDescription":"Participants received 2-6mg tablet orally twice daily for 8 weeks" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"128" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"133" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"261" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"128" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"133" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"261" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"70" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"58" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"128" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"58" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"75" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"133" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8", "OutcomeMeasureDescription":"Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 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.Change=(Week 8 Score - Baseline score)", "OutcomeMeasurePopulationDescription":"267 subjects in participant flow, 3 subjects randomized and not treated, 2 subjects does not have baseline PANSS scale, 1 subject take Blonanserin, which randomized to Risperidone group and no PANSS scale collected after first dose. Those 6 subjects excluded from Baseline Population. The Baseline population have 261 subjects.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"score on a scale", "OutcomeMeasureTimeFrame":"From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Blonanserin", "OutcomeGroupDescription":"Participants received 8-24mg tablet orally twice daily for 8 weeks." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Risperidone", "OutcomeGroupDescription":"Participants received 2-6mg tablet orally twice daily for 8 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"128" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"133" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"ITT analysis: At the end of treatment", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"128" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"133" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-30.59", "OutcomeMeasurementSpread":"18.53" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-33.56", "OutcomeMeasurementSpread":"16.89" } ] } } ] } },{ "OutcomeClassTitle":"PPS analysis: At the end of treatment", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"121" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"113" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-33.71", "OutcomeMeasurementSpread":"17.02" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-36.31", "OutcomeMeasurementSpread":"14.09" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"ANCOVA was employed to compare the changes of PANSS scores at week 8 relative to the baseline in these 2 groups. Least Squares Means for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.\n\nH0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone> 7.0).", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", "OutcomeAnalysisNonInferiorityComment":"The power is 80%, non-inferiority margin is 7.0.", "OutcomeAnalysisPValue":"<0.05", "OutcomeAnalysisPValueComment":"Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"Study center and grouping as fixed effects.", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"3.69", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.36", "OutcomeAnalysisCIUpperLimit":"7.75", "OutcomeAnalysisEstimateComment":"This is ITT analysis data." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"ANCOVA was employed to compare the changes of PANSS total scores at end of treatment relative to the baseline in these 2 groups. LSMeans for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.\n\nH0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone> 7.0).", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", "OutcomeAnalysisNonInferiorityComment":"The power is 80%, non-inferiority margin is 7.0.", "OutcomeAnalysisPValue":"<0.05", "OutcomeAnalysisPValueComment":"Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"Study center and grouping as fixed effects.", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"2.94", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.76", "OutcomeAnalysisCIUpperLimit":"6.65", "OutcomeAnalysisEstimateComment":"This is PPS analysis data." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Change in PANSS Subscale Score at the End of Treatment", "OutcomeMeasureDescription":"Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"week 8", "OutcomeMeasureDenomUnitsSelected":"Participants" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Change in PANSS 5-factor Model", "OutcomeMeasureDescription":"Mean change in PANSS 5-factor model from baseline at Week 8", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"Week 8", "OutcomeMeasureDenomUnitsSelected":"Participants" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Change in PANSS Symptom Scores", "OutcomeMeasureDescription":"Mean change in PANSS symptom scores from baseline at Week 8", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"Week 8", "OutcomeMeasureDenomUnitsSelected":"Participants" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Change in PANSS Symptom Scores From Baseline at Each Visit", "OutcomeMeasureDescription":"Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"Each Visit", "OutcomeMeasureDenomUnitsSelected":"Participants" } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"2", "EventsDescription":"Safety analysis set (SS, the primary analysis set for safety evaluation) SS of this study included all randomized subjects who have received at least 1 dose of the trial drug.\n\nThe SS population have 130 subjects in Blonanserin group, 134 subjects in Risperidone group.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Blonanserin", "EventGroupDescription":"Participants received 8-24mg tablet orally twice daily for 8 weeks", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"130", "EventGroupOtherNumAffected":"126", "EventGroupOtherNumAtRisk":"130" },{ "EventGroupId":"EG001", "EventGroupTitle":"Risperidone", "EventGroupDescription":"Participants received 2-6mg tablet orally twice daily for 8 weeks", "EventGroupSeriousNumAffected":"3", "EventGroupSeriousNumAtRisk":"134", "EventGroupOtherNumAffected":"122", "EventGroupOtherNumAtRisk":"134" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"chicken pox", "SeriousEventOrganSystem":"Skin and subcutaneous tissue disorders", "SeriousEventSourceVocabulary":"MedDRA (15.1)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"One subject (random number 234) in blonanserin group developed \"chicken pox\" and recovered after quarantine, symptomatic and supportive treatment; in the investigator's opinions, this case was unrelated to the study drug.", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"130" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"134" } ] } },{ "SeriousEventTerm":"Urinary retention", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA (15.1)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"130" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"134" } ] } },{ "SeriousEventTerm":"Gastrointestinal foreign matter", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA (15.1)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"130" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"134" } ] } },{ "SeriousEventTerm":"fever of unknown origin", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA (15.1)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"130" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"134" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Palpitations", "OtherEventOrganSystem":"Cardiac disorders", "OtherEventSourceVocabulary":"MedDRA (15.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"11", "OtherEventStatsNumAffected":"8", "OtherEventStatsNumAtRisk":"130" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"15", "OtherEventStatsNumAffected":"13", "OtherEventStatsNumAtRisk":"134" } ] } },{ "OtherEventTerm":"Tachycardia", "OtherEventOrganSystem":"Cardiac disorders", "OtherEventSourceVocabulary":"MedDRA (15.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"4", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"130" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"134" } ] } },{ "OtherEventTerm":"Sinus bradycardia", "OtherEventOrganSystem":"Cardiac disorders", "OtherEventSourceVocabulary":"MedDRA (15.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"130" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"134" } ] } },{ "OtherEventTerm":"Sinus arrhythmia", "OtherEventOrganSystem":"Cardiac disorders", "OtherEventSourceVocabulary":"MedDRA (15.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"130" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"134" } ] } },{ "OtherEventTerm":"Sinus tachycardia", "OtherEventOrganSystem":"Cardiac disorders", "OtherEventSourceVocabulary":"MedDRA (15.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"130" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"4", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"134" } ] } },{ "OtherEventTerm":"Galactorrhea", "OtherEventOrganSystem":"Endocrine disorders", "OtherEventSourceVocabulary":"MedDRA (15.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"130" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"134" } ] } },{ "OtherEventTerm":"Blurred vision", "OtherEventOrganSystem":"Eye disorders", "OtherEventSourceVocabulary":"MedDRA (15.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"130" 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