Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 6:34 PM
Study NCT ID:
NCT03919994
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2019-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)
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': 338}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Schizophrenia disease history', 'timeFrame': 'Baseline', 'description': 'Including time (years) since diagnosis as assessed from clinical history'}, {'measure': 'Number of comorbid conditions at baseline', 'timeFrame': 'Baseline', 'description': 'Assessed from clinical history'}, {'measure': 'Changes in comorbid conditions', 'timeFrame': 'Up to 12 months', 'description': 'The percent of patients experiencing each comorbid condition will be assessed at follow-up visits'}, {'measure': 'Number of LAI injections', 'timeFrame': 'Up to 12 months', 'description': 'Average number of injections during treatment period'}, {'measure': 'Number of patients switching or discontinuing LAI treatment', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alkermes', 'Schizophrenia', 'ARISTADA', 'Abilify Maintena', 'Invega Sustenna', 'Risperdal Consta', 'Cohort Study', 'Observational', 'Phase 4'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '36959874', 'type': 'DERIVED', 'citation': "Haider B, O'Sullivan AK, Bessonova L, Keane E, Achtyes E, Harvey PD, Kane JM, Saklad SR, Trotter JP, Claxton A, Polak T, McGrory J, Noori W, Sikora Kessler A, Yarlas A, Velligan D. Changes in Clinical Management of Patients with Schizophrenia Treated with Long-Acting Injectable Antipsychotics (LAIs), Including Telepsychiatry Use, During the COVID-19 Pandemic. Neuropsychiatr Dis Treat. 2023 Mar 17;19:623-634. doi: 10.2147/NDT.S394220. eCollection 2023."}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to describe characteristics, treatment patterns, and outcomes of patients with schizophrenia newly initiated on 1 of 4 FDA-approved atypical Long Acting Injectable (LAI) antipsychotics (ABILIFY MAINTENA®, ARISTADA®, INVEGA SUSTENNA® or RISPERDAL CONSTA®)', 'detailedDescription': 'This is a non-interventional, prospective, multi-center observational cohort study. Patients at behavioral health clinics will be enrolled and evaluated by health care professionals (e.g., psychiatrists) according to the standard of care. All patients will be followed for approximately 12 months from their enrollment visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with schizophrenia who are newly initiating LAI treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to speak, read and understand English\n* Diagnosis of schizophrenia as defined by the treating clinician\n* Newly initiating treatment with 1 of 4 atypical Long Acting Injectables (LAIs): Abilify Maintena, Aristada, Invega Sustenna, or Risperdal Consta)\n* Additional criteria may apply\n\nExclusion Criteria:\n\n* Currently participating or planning to participate in an interventional clinical study, or has completed participation in an interventional clinical study within 30 days before enrollment\n* In the opinion of the investigator, is currently an imminent danger to himself/herself. \\[Note: A prior history of suicidal ideation or suicidal attempt is not exclusionary.\\]\n* Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT03919994', 'briefTitle': 'Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'OASIS: Observational Study of LAIs In Schizophrenia', 'orgStudyIdInfo': {'id': 'ALKS 9072-A403N'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ABILIFY MAINTENA®', 'description': 'Subjects newly initiated'}, {'label': 'ARISTADA®', 'description': 'Subjects newly initiated'}, {'label': 'INVEGA SUSTENNA®', 'description': 'Subjects newly initiated'}, {'label': 'RISPERDAL CONSTA®', 'description': 'Subjects newly initiated'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 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