Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 8:53 AM
Study NCT ID:
NCT00428350
Status:
COMPLETED
Last Update Posted:
2009-03-25
First Post:
2007-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic
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': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-24', 'studyFirstSubmitDate': '2007-01-29', 'studyFirstSubmitQcDate': '2007-01-29', 'lastUpdatePostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in PANSS total score at Day 56 (LOCF)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in PANSS positive scale score at Day 56 (LOCF)'}, {'measure': 'Change from baseline in PANSS negative scale score at Day 56 (LOCF)'}, {'measure': 'Change from baseline in PANSS EC score at day 56 ,'}, {'measure': 'Change from baseline in MADRS total score at Day 56. etc'}]}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian\n* Female and/or male, aged between 18 and 60 years (inclusive)\n* Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: \\[20.1\\] paranoid schizophrenia, \\[20.2\\] hebephrenic schizophrenia, \\[20.3\\] catatonic schizophrenia, \\[20.5\\] undifferentiated schizophrenia\n\nExclusion Criteria:\n\n* CCMD-3 diagnosis of mental retardation\n* Psychosis judged to be the direct physiological effect of an abused medication or substance"}, 'identificationModule': {'nctId': 'NCT00428350', 'briefTitle': 'Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 24-Week, Multi-Centre, Open-Label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) With Daily Dose 600mg-750mg as Mono-Therapy in the Treatment of Acute Schizophrenic Patients', 'orgStudyIdInfo': {'id': 'D1443L00004'}, 'secondaryIdInfos': [{'id': 'SOLO'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Quetiapine Fumarate (Seroquel)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Research SIte', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Huzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.8703, 'lon': 120.0933}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jon Zhu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Gang Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing An Ding hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}