Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT01324167
Status:
UNKNOWN
Last Update Posted:
2011-03-28
First Post:
2011-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Gene Polymorphisms on Metabolic Features in Clozapine-treated Patients With Schizophrenia
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-25', 'studyFirstSubmitDate': '2011-03-24', 'studyFirstSubmitQcDate': '2011-03-25', 'lastUpdatePostDateStruct': {'date': '2011-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-28', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'schizoaffective disorder'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder']}, 'descriptionModule': {'briefSummary': 'The investigators would like to know the association of gene polymorphisms and metabolic adversities in clozapine-treated patients with schizophrenia in Taiwan.', 'detailedDescription': 'The atypical antipsychotics, such as olanzapine, risperidone, quetiapine, and ziprasidone, are effective in treating both the positive and negative symptoms in schizophrenia (Kelleher et al., 2002). However, atypical antipsychotics have been linked to several forms of morbidity, including obesity, hyperlipidemia, and type 2 diabetes mellitus (DM) (Bergman and Ader, 2005; Jin et al., 2004; Melkersson and Dahl, 2004). Compared with the general population, life expectancy in schizophrenic patients is shorter by as much as 20%, attributable to higher rates of suicide, accidental deaths, and natural causes such as cardiovascular disease and DM (Harris and Barraclough, 1998). Several studies have suggested that these metabolic abnormalities may lead to a greater vulnerability to cardiovascular disease and thus may contribute to the excessive mortality among schizophrenic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'schizophrenia or schizoaffective disorder patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fulfilled DSM-IV criteria of schizophrenia or schizoaffective disorder\n* 18-65 year of age\n* receiving clozapine for at least 6 months\n\nExclusion Criteria:\n\n* diabetes mellitus patients'}, 'identificationModule': {'nctId': 'NCT01324167', 'briefTitle': 'Effects of Gene Polymorphisms on Metabolic Features in Clozapine-treated Patients With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'Effects of Gene Polymorphisms on Metabolic Features in Clozapine-treated Patients With Schizophrenia', 'orgStudyIdInfo': {'id': '99037'}}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chun-Hsin Chen, MD', 'role': 'CONTACT', 'email': 'chunhsin57@yahoo.com.tw', 'phone': '886-2-29307930', 'phoneExt': '53961'}], 'facility': 'Taipei Medical University-WanFang Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chun-Hsin Chen, MD', 'role': 'CONTACT', 'email': 'chunhsin57@yahoo.com.tw', 'phone': '886-2-29307930', 'phoneExt': '53961'}], 'overallOfficials': [{'name': 'Chun-Hsin Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University WanFang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Chun-Hsin Chen', 'oldOrganization': 'Department of Psychiatry, WanFang Hospital'}}}}