Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT03285503
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2017-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2017-09-11', 'studyFirstSubmitQcDate': '2017-09-14', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Positive and Negative Symptoms Scale (PANSS)', 'timeFrame': 'up to 24 weeks', 'description': 'To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.'}], 'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': 'up to 24 weeks', 'description': 'To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.'}, {'measure': 'time of maximum observed plasma concentration (tmax)', 'timeFrame': 'up to 24 week', 'description': 'To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.'}, {'measure': 'AUC672h', 'timeFrame': 'up to 24 weeks', 'description': 'To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.'}, {'measure': 'Apparent clearance after extravascular administration', 'timeFrame': 'up to 24 weeks', 'description': 'To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'up to 24 weeks', 'description': 'Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment'}, {'measure': 'Vital Signs', 'timeFrame': 'up to 24 weeks', 'description': 'Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs'}, {'measure': 'Laboratory Examination', 'timeFrame': 'up to 24 weeks', 'description': 'Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '41034820', 'type': 'DERIVED', 'citation': 'Dong F, Wang F, Yuan X, Zhai Y, Uki M, Jiang T, Li A. Single- and multiple-dose pharmacokinetics, safety, and tolerability of Aripiprazole once-monthly, long-acting intramuscular injection for Chinese adults with schizophrenia. BMC Psychiatry. 2025 Oct 1;25(1):912. doi: 10.1186/s12888-025-07407-w.'}]}, 'descriptionModule': {'briefSummary': 'This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.', 'detailedDescription': 'To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);\n2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);\n3. subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent.\n\nExclusion Criteria:\n\n1. Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR;\n2. Subjects who are alcoholomania or independent of drug, or have drug abuse history;\n3. Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing;\n\nOther protocol-defined inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03285503', 'briefTitle': 'PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Beijing Research Institute'}, 'officialTitle': 'A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration', 'orgStudyIdInfo': {'id': '031-403-00049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '400 mg group', 'description': 'Aripiprazole IM depot 400mg will be administered every four weeks for 20 weeks after drug switch / steady dose of oral aripiprazole tablets (each subject will receive 5 intramuscular injections totally).', 'interventionNames': ['Drug: Aripiprazole IM Depot']}], 'interventions': [{'name': 'Aripiprazole IM Depot', 'type': 'DRUG', 'otherNames': ['ABILIFY MAINTENA'], 'description': 'administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.', 'armGroupLabels': ['400 mg group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100088', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anding Hospital of Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Tao Jiang, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anding Hospital of Capital Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Beijing Research Institute', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}