Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-23 @ 2:53 PM
Study NCT ID:
NCT01746134
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Management of Schizophrenia in Clinical Practice (MOSAIC)
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 557}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-12-04', 'studyFirstSubmitQcDate': '2012-12-06', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive and Negative Symptoms of Schizophrenia (PANSS)', 'timeFrame': 'up to 5 years'}, {'measure': 'Clinical Global Impression Schizophrenia Scale (CGI-SCH)', 'timeFrame': 'up to 5 years'}, {'measure': 'Cognitive function (Fluency, Digit Symbol-Coding, Trail Making Test)', 'timeFrame': 'up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Negative Symptom Assessment Scale (NSA4)', 'timeFrame': 'up to 5 years'}, {'measure': 'Pharmacologic/behavioural treatments used in usual care settings: intervention', 'timeFrame': 'up to 5 years'}, {'measure': 'Pharmacologic/behavioural treatments used in usual care settings: dose', 'timeFrame': 'up to 5 years'}, {'measure': 'Pharmacologic/behavioural treatments used in usual care settings: duration', 'timeFrame': 'up to 5 years'}, {'measure': 'Personal and Social Performance (PSP)', 'timeFrame': 'up to 5 years'}, {'measure': 'Schizophrenia Quality of Life Scale (SQLS)', 'timeFrame': 'up to 5 years'}, {'measure': 'Schizophrenia Caregiver Questionnaire', 'timeFrame': 'up to 5 years'}, {'measure': 'Maslach Burnout Inventory (MBI)', 'timeFrame': 'up to 5 years'}]}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This study is a disease-based registry designed to follow patients with a DSM-IV-TR (Diagnostic and Statistic Manual of Mental Disorders, Text Revision) diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder treated in usual care settings for up to 5 years. The registry seeks to describe the course of disease in schizophrenia, including cognitive function and negative symptoms, its treatment, and its burden of disease for participants, caregivers, clinicians, and society as a whole.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with schizophrenia, schizoaffective disorder, or schizophreniform across the disease spectrum treated in usual care settings', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder\n* Participants presenting with the normal course of care in usual treatment settings\n* Able to read and speak English\n* Able and willing to provide informed consent\n* Able and willing to comply with the study protocol\n\nExclusion Criteria:\n\n* Participants enrolled as subjects in clinical trials at registry enrollment\n* Participants anticipating they will be unable to participate in regularly scheduled assessments as per protocol'}, 'identificationModule': {'nctId': 'NCT01746134', 'briefTitle': 'The Management of Schizophrenia in Clinical Practice (MOSAIC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Prospective, Non-Interventional Registry of Diverse Patients With Schizophrenia Across the Disease Spectrum in Usual Care Settings: Course of Disease, Treatments, and Burden of Illness', 'orgStudyIdInfo': {'id': 'ML28264'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91344', 'city': 'Granada Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.26472, 'lon': -118.52314}}, {'zip': '90095-6968', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '6514', 'city': 'Cedar Rapids', 'state': 'Connecticut', 'country': 'United States'}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60653', 'city': 'Chicago', 'state': 'Florida', 'country': 'United States'}, {'zip': '32601', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32608-1197', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United 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