Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT00137020
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2005-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': {'count': 294}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2006-04'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2005-08-26', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline In Clinical Global Impression Severity (CGI-S)'}, {'measure': 'Clinical Global Impression Improvement (CGI-I)'}, {'measure': 'Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total'}, {'measure': 'Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS)'}, {'measure': 'Change from baseline in scores on the MADRS Without Items 4, 5'}, {'measure': 'Change from baseline in Global Assessment of Functioning (GAF)'}, {'measure': 'Change From Baseline In Drug Attitude Inventory (DAI)'}, {'measure': 'Change From Baseline In Weight'}, {'measure': 'Change From Baseline In Prolactin And Lipid Levels'}, {'measure': 'Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score'}, {'measure': 'Change From Baseline in Barnes Akathisia Scale (BAS)'}, {'measure': 'Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Movement Ratings Total Score'}, {'measure': 'Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Global Judgment Of Severity Total Score'}]}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Psychotic Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281117&StudyName=Clinical+Effect+Of+Cross+Titration+Of+Antipsychotics+With+Ziprasidone+In+Schizophrenia+Or+Schizioaffective+Disorder', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Primary diagnosis of schizophrenia or schizoaffective disorder, using DSM-IV criteria.\n* Currently receiving either haloperidol, olanzapine or risperidone within -/+ 25% of the recommended daily dose (as delineated by the medication's package insert\n\nExclusion Criteria:\n\n* Resistance to conventional antipsychotic drugs\n* With antipsychotic agents other than olanzapine, risperidone or haloperidol at start of treatment regimen within 12 hours prior to first dose of study drug"}, 'identificationModule': {'nctId': 'NCT00137020', 'briefTitle': 'Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multi-Center Study to Examine The Clinical Effects of Cross Titration of Antipsychotics With Ziprasidone in Subjects With Schizophrenia or Schizoaffective Disorder', 'orgStudyIdInfo': {'id': 'A1281117'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ziprasidone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Asyut', 'country': 'Egypt', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Tanta', 'country': 'Egypt', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'zip': 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