Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-25 @ 12:49 AM
Study NCT ID:
NCT01959659
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2013-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia to Describe Medical Resource Utilization and Burden of Illness
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1431}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2013-09-26', 'studyFirstSubmitQcDate': '2013-10-08', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical resource utilization (in-/out-patient hospital services, community-based day service, other health care contacts) of patients with persistent symptoms of schizophrenia', 'timeFrame': 'in the 3 to 12 months prior to screening'}], 'secondaryOutcomes': [{'measure': 'Level/severity of schizophrenia symptoms: Clinical rating scales scores (PANSS, CGI-S, PSP, WoRQ, NSA-4, HoNOS)', 'timeFrame': 'Observational visit Day 1'}, {'measure': 'Patient health-related quality of life (HRQoL) questionnaires', 'timeFrame': 'Observational visit Day 1'}, {'measure': "Caregiver's burden as assessed by questionnaires", 'timeFrame': 'Observational visit Day 1'}]}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This non-interventional, cross-sectional survey and retrospective review will evaluate the medical resource utilization and burden of illness in patients who have persistent symptoms of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not had an acute exacerbation in the 3 months prior to enrolment. Medical records will be reviewed for a minimum of 3 months and up to 12 months prior to screening. Data collection at a single visit will include rating scales and questionnaires that reflect the clinical status and the quality of life of the patients and the economic impact of schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with persistent symptoms of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not had an acute exacerbation in the last 3 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Patients who have a clinical diagnosis of schizophrenia as documented in their medical records\n* Patients who, in the opinion of the investigator, have had on-going, persistent symptoms of schizophrenia for at least the last 3 months prior to enrolment\n* Patients who, in the opinion of the investigator, have been prescribed adequate doses of antipsychotic treatment for at least the last 3 months\n* Patient has adequate spoken local language\n\nExclusion Criteria:\n\n* Acute exacerbation of schizophrenia within the last 3 months prior to enrolment\n* Enrolment in an interventional study'}, 'identificationModule': {'nctId': 'NCT01959659', 'briefTitle': 'A Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia to Describe Medical Resource Utilization and Burden of Illness', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'orgStudyIdInfo': {'id': 'MN28222'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3076', 'city': 'Epping', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.77271, 'lon': 151.08184}}, {'zip': '4053', 'city': 'Everton Park', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.40732, 'lon': 152.9884}}, {'zip': '615 00', 'city': 'Brno', 'country': 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