Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT00265551
Status:
COMPLETED
Last Update Posted:
2007-12-10
First Post:
2005-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating SCA-136 in Subjects With Acute Exacerbations of 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': 'D000077152', 'term': 'Olanzapine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-07', 'studyFirstSubmitDate': '2005-12-12', 'studyFirstSubmitQcDate': '2005-12-12', 'lastUpdatePostDateStruct': {'date': '2007-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to day 42 on the positive subscale of the SCI-PANNS'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to day 42 on:'}, {'measure': 'SCI-PANNS total score'}, {'measure': 'negative symptom sub-scale score of SCI-PANNS'}, {'measure': 'general psychopathology subscale score of SCI-PANNS'}, {'measure': 'response rate based upon SCI-PANNS total score'}, {'measure': 'BPRS score'}, {'measure': 'CGI-S score'}, {'measure': 'CGI-I score'}, {'measure': 'Cognitive assessments scores'}]}, 'conditionsModule': {'keywords': ['Schizophrenia'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '24613032', 'type': 'DERIVED', 'citation': 'Shen JH, Zhao Y, Rosenzweig-Lipson S, Popp D, Williams JB, Giller E, Detke MJ, Kane JM. A 6-week randomized, double-blind, placebo-controlled, comparator referenced trial of vabicaserin in acute schizophrenia. J Psychiatr Res. 2014 Jun;53:14-22. doi: 10.1016/j.jpsychires.2014.02.012. Epub 2014 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of schizophrenia\n* Ability to remain hospitalized for at least first 4 weeks of study\n* Needs hospitalization due to worsening of schizophrenia\n\nExclusion Criteria:\n\n* Type 1 or 2 diabetes\n* Previous use of clozapine\n* Serious medical illness other than schizophrenia'}, 'identificationModule': {'nctId': 'NCT00265551', 'briefTitle': 'Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 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