Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-29 @ 1:53 PM
Study NCT ID:
NCT00206128
Status:
COMPLETED
Last Update Posted:
2013-01-04
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia
Sponsor:
Organization:
Raw JSON
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The SR designation was changed to XR after consultation with FDA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A stable dose of quetiapine IR between 300 and 800 mg/day within 4 weeks prior to the enrolment visit (Visit 1) as judged by the investigator.\n* Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.\n* Able to understand and comply with the requirements of the study, as judged by the investigator.\n\nExclusion Criteria:\n\n* Meeting the criteria for any other (than schizophrenia) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I diagnosis, concomitant organic mental disorder or mental retardation.\n* Patients with substance abuse or dependence, as defined by DSM-IV, and not in full remission. A urine drug screen test will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.\n* Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the investigator.\n* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.'}, 'identificationModule': {'nctId': 'NCT00206128', 'briefTitle': 'Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '6-week Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Evaluate the Feasibility of Switching From Immediate-release Quetiapine Fumarate (SEROQUEL) to Sustained-release Quetiapine Fumarate in Outpatients With Schizophrenia (Abbreviated)', 'orgStudyIdInfo': {'id': 'D1444C00146'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Seroquel SR', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 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