Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-10 @ 5:28 AM
Study NCT ID:
NCT01157559
Status:
COMPLETED
Last Update Posted:
2010-07-07
First Post:
2010-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety With Ziprasidone in First-episode Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C092292', 'term': 'ziprasidone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-06', 'studyFirstSubmitDate': '2010-06-30', 'studyFirstSubmitQcDate': '2010-07-06', 'lastUpdatePostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms assessment by objective rating scales', 'timeFrame': 'week 1', 'description': 'PANSS total score, SANS, clinical global impression scale, GAF'}, {'measure': 'Symptoms assessment by objective rating scales', 'timeFrame': 'week 2', 'description': 'PANSS total score, SANS, clinical global impression scale, GAF'}, {'measure': 'Symptoms assessment by objective rating scales', 'timeFrame': 'week 4', 'description': 'PANSS total score, SANS, clinical global impression scale, GAF'}, {'measure': 'Symptoms assessment by objective rating scales', 'timeFrame': 'week 6', 'description': 'PANSS total score, SANS, clinical global impression scale, GAF'}, {'measure': 'Symptoms assessment by objective rating scales', 'timeFrame': 'week 8', 'description': 'PANSS total score, SANS, clinical global impression scale, GAF, DAS-S'}], 'secondaryOutcomes': [{'measure': 'Assessment of adverse events by objective rating scales and self report scales', 'timeFrame': 'one-month', 'description': 'Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale'}, {'measure': 'Assessment of adverse events by objective rating scales and self report scales', 'timeFrame': 'two-month.', 'description': 'Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['First Episode Psychosis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who meet DSM-IV criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder\n\nExclusion Criteria:\n\n* Patients with previously prescribed antipsychotic medication in 2 weeks or more\n* patients with substance-induced psychotic disorder, serious suicide attempt, neurological disorder, etc.'}, 'identificationModule': {'nctId': 'NCT01157559', 'briefTitle': 'Efficacy and Safety With Ziprasidone in First-episode Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study', 'orgStudyIdInfo': {'id': '2006-Zeldox in FEP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ziprasidone', 'type': 'DRUG', 'description': '8 week prospective study'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Department of Psychiatry, Chonbuk national University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Heo psychiatric Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Jeonju Jesus Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Young Chul Chung/Professor of Psychiatry', 'oldOrganization': 'Chonbuk National University Hospital, Jeonju, Korea'}}}}