Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-03-28 @ 10:54 AM
Study NCT ID:
NCT00498004
Status:
TERMINATED
Last Update Posted:
2008-11-04
First Post:
2007-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life (QOL) in Female Patient With 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': 'D000069348', 'term': 'Quetiapine Fumarate'}, {'id': 'D018967', 'term': 'Risperidone'}], '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'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'difficult to recruit subject', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-03', 'studyFirstSubmitDate': '2007-07-06', 'studyFirstSubmitQcDate': '2007-07-06', 'lastUpdatePostDateStruct': {'date': '2008-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "QOL measured by Korean version of Heinrich's Quality of Life Scale", 'timeFrame': '8weeks'}], 'secondaryOutcomes': [{'measure': 'Korean version of Female Sexual Function Index', 'timeFrame': '8 weeks'}, {'measure': 'Korean version of Female Sexual Distress Scale', 'timeFrame': '8 weeks'}, {'measure': 'Hormonal levels (Prolactin, Estradiol, Free Testosterone, FSH, LH', 'timeFrame': '8 weeks'}, {'measure': 'Psychopathology (Brief Psychiatric Rating Scale)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Quality of Life', 'Schizophrenia', 'Quetiapine', 'Risperidone'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '17017825', 'type': 'BACKGROUND', 'citation': 'Jung DU, Conley RR, Kelly DL, Kim DW, Yoon SH, Jang JH, Shin JG, Shim JC. Prevalence of bone mineral density loss in Korean patients with schizophrenia: a cross-sectional study. J Clin Psychiatry. 2006 Sep;67(9):1391-6. doi: 10.4088/jcp.v67n0909.'}]}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to demonstrate clinical and statistical superiority of quetiapine compared to risperidone in Korean version of Heinrich's Quality of Life Scale after 8 weeks trial of drugs.", 'detailedDescription': "Prolactin related adverse events are closely related to patient's perception on their illness and quality of life . Poor subjective wellbeing induced by prolactin elevation after antipsychotic drug treatment can complicate the clinical outcomes of treatment.Quetiapine has negligible effects on the elevation of prolactin and does not produce hyperprolactinemia related adverse events such as amenorrhea, galactorrhea that may disturb quality of life in famel patient. In this Randomized, Open Label, 8-week Study, the impact of quetiapine and risperidone on quality of life in female patients with schizophrenia will be compared."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis: Schizophrenia (DSM-IV)\n2. Female, Age: between 18-60 years\n3. Who either need first time treatment with antipsychotic drug or recently\n4. Sign written informed consent\n\nExclusion Criteria:\n\n1. Taking other psychiatric medications during last 30 days\n2. Refractory schizophrenia\n3. A current medical illness associated with sexual dysfunction\n4. Previous history of no response to quetiapine or risperidone treatment\n5. Previous enrolment or randomisation of treatment in the present study.\n6. Participation in a clinical study during the last 90 days.\n7. Pregnancy\n8. Alcohol or substance abuser'}, 'identificationModule': {'nctId': 'NCT00498004', 'briefTitle': 'Quality of Life (QOL) in Female Patient With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Randomized, Open Label, 8-Week Study of Quetiapine and Risperidone on Quality of Life in Female With Schizophrenia', 'orgStudyIdInfo': {'id': 'QOL Study 2007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Quetiapine, Risperidone', 'type': 'DRUG', 'description': 'The dose of quetiapine will be titrated over 4 days to 300mg/day (50mg at day 1, 100mg at day 2, 200mg at day 3 and 300mg at day 4) and thereafter flexible dose will be administered depending on the clinical state. The dose of risperidone will be titrated as following 2mg at day 1 and 4mg at day 4 and thereafter flexible dose will be administered depending on the clinical state. The dosage of drugs should be 400-800mg/day of quetiapine and 4-6mg/day of risperidone between 6 and 8 weeks of trial.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '614-735', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Joo-Cheol Shim, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Trial Center, Paik hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Joo Shim', 'oldOrganization': 'Inje University, Busan Paik Hospital'}}}}