Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-20 @ 6:43 PM
Study NCT ID:
NCT02453893
Status:
UNKNOWN
Last Update Posted:
2015-05-27
First Post:
2015-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C081732', 'term': 'iloperidone'}, {'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 288}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2015-05-19', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'the score of clinical global impressions to evaluation the severity of illness', 'timeFrame': '8 weeks'}, {'measure': 'the score of clinical global impressions to evaluation the improvement of illness', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Iloperidone', 'Risperidone', 'PANSS'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical study. Chinese subjects with Ischemic Schizophrenia.', 'detailedDescription': 'Subjects will randomly enter into one of two groups,the period of treatment is 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women aged 18 to 65 years with schizophrenia;\n* PANSS total score of at least 70 at screening and baseline;\n* at least 2 more than 4 points in 7 of PANSS-P;\n* informed consent.\n\nExclusion Criteria:\n\n* allergy with iloperidone or risperidone;\n* psychotic symptoms failing to improve after sufficient exposure to 2 antipsychotic treatment;\n* any other primary Axis 1 psychiatric diagnosis;\n* a history of alcohol or drug dependence in recent 1 year;\n* at imminent risk of harm to self or others;\n* systolic blood pressure≤90mmHg。'}, 'identificationModule': {'nctId': 'NCT02453893', 'briefTitle': 'Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'Double-blind,Double-simulation,Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'CSPC-HC103/PRO/Ⅱ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oral iloperidone', 'description': '2\\~12mg/day for 2 weeks,12\\~24mg/day for 6 weeks.', 'interventionNames': ['Drug: Iloperidone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'oral risperidone', 'description': '1\\~3mg/day for 2 weeks,3\\~6mg/day for 6 weeks.', 'interventionNames': ['Drug: Risperidone']}], 'interventions': [{'name': 'Iloperidone', 'type': 'DRUG', 'armGroupLabels': ['oral iloperidone']}, {'name': 'Risperidone', 'type': 'DRUG', 'armGroupLabels': ['oral risperidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Hua fang, Ph.D', 'role': 'CONTACT', 'phone': '86-021-34773128'}], 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wang yu mei, master', 'role': 'CONTACT', 'phone': '86-311-67808816'}], 'overallOfficials': [{'name': 'Li hua fang, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Mental Health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}