Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-30 @ 1:15 AM
Study NCT ID:
NCT01214135
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2010-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Non-interventional Study to Evaluate the Use of Seroquel Extended Release (XR) and Immediate Release (IR) in the Clinical Practice of Inpatients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-10', 'studyFirstSubmitDate': '2010-09-24', 'studyFirstSubmitQcDate': '2010-10-01', 'lastUpdatePostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia', 'timeFrame': 'every day for the time period of 15 Oct to 31 Dec 2010'}], 'secondaryOutcomes': [{'measure': 'To investigate comorbidities of patients with schizophrenia receiving Seroquel XR and IR', 'timeFrame': 'every day for the time period of 15 Oct to 31 Dec 2010'}, {'measure': 'To investigate whether Seroquel XR and Seroquel IR are used to treat different types of inpatients with schizophrenia by evaluation of patient characteristics', 'timeFrame': 'every day for the time period of 15 Oct to 31 Dec 2010'}, {'measure': 'To investigate the treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR', 'timeFrame': 'every day for the time period of 15 Oct to 31 Dec 2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mental disorder', 'antipsychotic treatment'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '23983980', 'type': 'DERIVED', 'citation': 'Eriksson L, Hallerback T, Jorgensen L, Carlborg A. Use of quetiapine XR and quetiapine IR in clinical practice for hospitalized patients with schizophrenia: a retrospective study. Ther Adv Psychopharmacol. 2012 Dec;2(6):217-26. doi: 10.1177/2045125312453935.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this non-interventional study is to investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia. This will be done by a retrospective review of medical records to evaluate patients treated with Seroquel XR or Seroquel IR as primary antipsychotic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 300 patients with schizophrenia who have been hospitalized during the study period (1st of July 2009 - 30th of September 2010).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia.\n* At least one dose of Seroquel XR or Seroquel IR during the study period (1st of July 2009 - 30th of September 2010).\n* Hospitalization due to psychotic symptoms at any time during the study period (1st of July 2009 - 30th of September 2010) and with admission and discharge dates available.\n\nExclusion Criteria:\n\n* Participation in a clinical trial during the study period.\n* Treatment in forensic care according to LRV ("Lagen om Rättspsykiatrisk Vård").'}, 'identificationModule': {'nctId': 'NCT01214135', 'acronym': 'SPIN', 'briefTitle': 'A Retrospective Non-interventional Study to Evaluate the Use of Seroquel Extended Release (XR) and Immediate Release (IR) in the Clinical Practice of Inpatients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Retrospective, Non-interventional Study to Evaluate the Use of Seroquel XR and Seroquel IR in the Clinical Practice of Inpatients With Schizophrenia', 'orgStudyIdInfo': {'id': 'NIS-NSE-SER-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with a diagnosis of schizophrenia who have been hospitalized and received at least one dose of Seroquel XR or Seroquel IR during the study period (1st of July 2009 - 30th of September 2010).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Falköping', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.17347, 'lon': 13.55068}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Helsingborg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'city': 'Karlskrona', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.16156, 'lon': 15.58661}}, {'city': 'Karlstad', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.3793, 'lon': 13.50357}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Mölndal', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}, {'city': 'Öjebyn', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 65.35, 'lon': 21.4}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Trollhättan', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.28365, 'lon': 12.28864}}, {'city': 'Umeå', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Vaxjo', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.87767, 'lon': 14.80906}}], 'overallOfficials': [{'name': 'Dr Eva Dencker Vansvik, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Dr Lars Eriksson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rättspsykiatriska Vårdkedjan, Hisings-Backa, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca'}}}}