Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-07 @ 3:57 AM
Study NCT ID:
NCT03287505
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-24', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-09-14', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Positive and Negative Symptoms Scale (PANSS)', 'timeFrame': 'up to 20 weeks', 'description': 'To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.'}], 'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration', 'timeFrame': 'up to 20 weeks', 'description': 'To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857'}, {'measure': 'Time of Maximum Concentration', 'timeFrame': 'up to 20 weeks', 'description': 'To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857'}, {'measure': 'AUC0-∞', 'timeFrame': 'up to 20 weeks', 'description': 'To assess the area under the curve for period of medication, from 0 till infinity (AUC0-∞) of aripiprazole and its main metabolite OPC-14857'}, {'measure': 'Apparent clearance after extravascular administration', 'timeFrame': 'up to 20 weeks', 'description': 'To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'up to 20 weeks', 'description': 'Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment.'}, {'measure': 'Vital Signs', 'timeFrame': 'up to 20 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 20 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 single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.', 'detailedDescription': 'In this study, a single-center, single-dose, single-administration trial will be carried out in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24 patients with oral tolerance of this drug.\n\nIn this study, the washout period before administration is designed as a 35-day duration before administration of the investigational drug (aripiprazoleIM Depot), screening period a 4-week duration (28 days) before administration of the investigational drug, observation period after administration a 20-week duration after administration of the investigational drug and hospital stay a minimum 35-day duration after administration of the investigational drug.'}, '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. Patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of DSM-IV-TR;\n2. Score of Positive and Negative Syndrome Scale (PANSS): ≥120;\n3. Patients with a complication or a history of diabetic mellitus;\n4. Subjects who are alcoholemia overdependent of drug, or have drug abuse history;\n\nOther protocol-defined inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03287505', 'briefTitle': 'Aripiprazole IM Depot for Chinese Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Beijing Research Institute'}, 'officialTitle': 'Evaluation of Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation by Single Administration in Chinese Patients With Schizophrenia: a Single-center, Uncontrolled, Open -Label Trial', 'orgStudyIdInfo': {'id': '031-403-00050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abilify IM Depot 300mg by once', 'description': '300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects;', 'interventionNames': ['Drug: Aripiprazole IM Depot']}, {'type': 'EXPERIMENTAL', 'label': 'Abilify IM Depot 400mg by once', 'description': '400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects.', '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 300 and 400mg once in patients with schizophrenia.', 'armGroupLabels': ['Abilify IM Depot 300mg by once', 'Abilify IM Depot 400mg by once']}]}, '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': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Beijing Research Institute', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}