Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-29 @ 9:06 PM
Study NCT ID:
NCT03386851
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2017-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-02-16', 'releaseDate': '2022-05-12'}], 'estimatedResultsFirstSubmitDate': '2022-05-12'}}, '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': 'ACTUAL', 'count': 1030}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-10', 'studyFirstSubmitDate': '2017-12-22', 'studyFirstSubmitQcDate': '2017-12-22', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR', 'timeFrame': 'until 28 days after discontinuation'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline to last visit in Clinical Global Impression - Severity of Illness scale (CGI-S) score.', 'timeFrame': 'at least 12, 24 weeks interval from baseline'}, {'measure': 'Clinical Global Impression - Improvement scale (CGI-I) score at the last visit', 'timeFrame': 'at least 12, 24 weeks interval from baseline'}, {'measure': 'Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score.', 'timeFrame': 'at least 12, 24 weeks interval from baseline'}, {'measure': 'Overall judgement at last visit compared to baseline, judged holistically according to clinical symptoms: "Effective", "No effect", "Worsen"', 'timeFrame': 'at least 12, 24 weeks interval from baseline'}]}, 'oversightModule': {'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Bipolar 1 Disorder']}, 'descriptionModule': {'briefSummary': 'This is a Post-Marketing Surveillance (PMS) of Abilify Maintena® Injections in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: Ministry of Food and Drug Safety(MFDS) Notification).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Schizophrenia or bipolar 1 disorder', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients with schizophrenia or bipolar 1 disorder\n* Patients who are prescribed Abilify Maintena® Injections treatment as per investigator's medical judgment\n* Patients giving written authorization to use their personal and health data and starting Abilify Maintena® Injections treatment after agreement is in place and investigators provide the explanation about objective and feature of the surveillance\n\nExclusion Criteria:\n\n* Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify Maintena® Injections\n* Elderly patients with dementia related psychosis\n* Patients who have been treated with Abilify Maintena® Injections\n* Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the Clinical Global Impression-Severity(CGI-S)\n* Patients participating in other clinical trial\n* All patients who in medical judgment of the investigator would not be appropriate for inclusion criteria in the surveillance"}, 'identificationModule': {'nctId': 'NCT03386851', 'briefTitle': 'Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Post-Marketing Surveillance of Safety and Effectiveness of Abilify Maintena® Injections in Korean Patients With Schizophrenia or Bipolar 1 Disorder Under the "New Drug Re-Examination"', 'orgStudyIdInfo': {'id': '031-402-00089'}}, 'contactsLocationsModule': {'locations': [{'city': 'Gwangju', 'country': 'South Korea', 'facility': 'St.John of God Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-05-12', 'type': 'RELEASE'}, {'date': '2023-02-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Korea Otsuka Pharmaceutical Co., Ltd.'}}}}