Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT00758251
Status:
COMPLETED
Last Update Posted:
2010-12-10
First Post:
2008-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation of Change in Clinical Global Impression Scores in Schizophrenia Patients Receiving Seroquel XR Treatment
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-08', 'studyFirstSubmitDate': '2008-09-23', 'studyFirstSubmitQcDate': '2008-09-23', 'lastUpdatePostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in CGI scores and BPRS comparing visits 1 and 3.', 'timeFrame': 'twice with 4 week interval'}], 'secondaryOutcomes': [{'measure': 'To evaluate compliance to therapy', 'timeFrame': 'twice with 4 week interval'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Seroquel XR', 'CGI'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess severity of illness in schizophrenia patients in routine clinical practice at the time of entry in the study and after the treatment with Seroquel XR for 8 weeks.\n\nPLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with Schizophrenia prescribed on Seroquel XR according to the approved product information before inclusion in this non-interventional study\n* Signed and dated Patient Informed Consent (ICF)\n\nExclusion Criteria:\n\n* Hypersensitivity to the active substance or to any of the excipients of Seroquel XR'}, 'identificationModule': {'nctId': 'NCT00758251', 'briefTitle': 'Observation of Change in Clinical Global Impression Scores in Schizophrenia Patients Receiving Seroquel XR Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Observation of Change in Clinical Global Impression Scores in Schizophrenia Patients Receiving Seroquel XR Treatment', 'orgStudyIdInfo': {'id': 'NIS-NLV-SER-2008/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Adult schizophrenia patients already on Seroquel XR therapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bauska', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.4071, 'lon': 24.18733}}, {'city': 'Cēsis', 'country': 'Latvia', 'facility': 'Research SIte', 'geoPoint': {'lat': 57.31188, 'lon': 25.27456}}, {'city': 'Daugavpils', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'city': 'Dobele', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.62372, 'lon': 23.2751}}, {'city': 'Jelgava', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.65, 'lon': 23.71278}}, {'city': 'Jēkabpils', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.49903, 'lon': 25.85735}}, {'city': 'Jūrmala', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.968, 'lon': 23.77038}}, {'city': 'Kuldīga', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.97399, 'lon': 21.95721}}, {'city': 'Liepāja', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.50474, 'lon': 21.01085}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Saldus', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.66363, 'lon': 22.48807}}, {'city': 'Strenči', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.62574, 'lon': 25.68535}}, {'city': 'Talsi', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.24562, 'lon': 22.58137}}, {'city': 'Tukums', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.96764, 'lon': 23.15554}}, {'city': 'Valmiera', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.54108, 'lon': 25.42751}}], 'overallOfficials': [{'name': 'Agrita Hartmane', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Latvia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Janis Dobelis, Country Manager', 'oldOrganization': 'AstraZeneca MC Latvia'}}}}