Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-04-15 @ 4:58 PM
Study NCT ID:
NCT02220712
Status:
COMPLETED
Last Update Posted:
2021-01-25
First Post:
2014-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CL_OPCJ_RDA_Team@otsuka.jp', 'phone': '+81-3-6361-7366', 'title': 'Director of Clinical Trials', 'organization': 'Otsuka Pharmaceutical Co., LTD.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD)', 'description': 'Only treatment-emergent adverse events (TEAEs) were assessed for this trial.', 'eventGroups': [{'id': 'EG000', 'title': 'OPC-14597 IMD', 'description': 'Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 15, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Injection site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Blood insulin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}], 'seriousEvents': [{'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-14597 IMD (First Dose)', 'description': 'Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals'}, {'id': 'OG001', 'title': 'OPC-14597 IMD (Second Dose)', 'description': 'Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals'}, {'id': 'OG002', 'title': 'OPC-14597 IMD (Third Dose)', 'description': 'Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals'}, {'id': 'OG003', 'title': 'OPC-14597 IMD (Fourth Dose)', 'description': 'Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals'}, {'id': 'OG004', 'title': 'OPC-14597 IMD (Fifth', 'description': 'Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals'}], 'classes': [{'categories': [{'measurements': [{'value': '91.9', 'spread': '29.4', 'groupId': 'OG000'}, {'value': '141', 'spread': '54.0', 'groupId': 'OG001'}, {'value': '171', 'spread': '76.1', 'groupId': 'OG002'}, {'value': '198', 'spread': '102', 'groupId': 'OG003'}, {'value': '201', 'spread': '88.9', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '672 hours postdose of the first, second, third, fourth, and fifth IMD injections', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included subjects whose plasma concentrations were measured without deviation at all blood sampling timepoints during the OPC-14597 IMD treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OPC-14597 IMD', 'description': 'Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Exacerbation of symptoms of an underlying disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OPC-14597 IMD', 'description': 'Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'spread': '11.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety analysis set included subjects who received aripiprazole IMD at least once and who had safety data after aripiprazole IMD administrationn.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2014-08-18', 'resultsFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-05', 'studyFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections', 'timeFrame': '672 hours postdose of the first, second, third, fourth, and fifth IMD injections'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aripiprazole', 'Deltoid'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM)-IV-Text Revision (TR) (295.30, 295.10, 295.20, 295.90, 295.60)\n* Patients who have provided written informed consent by themselves (If the patient is a minor, written consent from a legal representative must be obtained in addition to the patient's own written informed consent.)\n* Patients, both male and female, aged 18 years or older, but younger than 65 years, at the time of obtaining informed consent\n* Patients with a body mass index of 18.5 or higher and lower than 35.0\n* Patients whose mental condition is stable or well maintained for 2 weeks or more without any change to dosage regimen for their non-aripiprazole oral atypical antipsychotic monotherapy prior to obtaining informed consent\n* Patients who have received aripiprazole in the past\n\nExclusion Criteria:\n\n* Patients diagnosed as having a mental disorder other than schizophrenia, as defined by DSM-IV-TR criteria.\n* Patients with a history or complication of diabetes.\n* Patients with hepatic, renal, cardiac, or hematopoietic disorders.\n* Female patients who are pregnant or lactating, who may possibly be pregnant, who wish to become pregnant, or male patients whose partner wishes to become pregnant.\n* Patients who have a drug allergy or drug hypersensitivity\n* Patients for whom clozapine has been ineffective, patients who have responded only to clozapine, or patients who are currently being treated with clozapine.\n* Patients with a complication of Parkinson's Disease (excluding drug-induced Parkinsonism).\n* Patients with a history or a complication of neuroleptic malignant syndrome, rhabdomyolysis, tardive dyskinesia, paralytic ileus or water intoxication.\n* Patients with a history or a complication of psychological or behavioral abnormalities associated with use of psychoactive substances (abuse of alcohol, narcotics, or organic solvent, etc).\n* Patients with a history or a complication of suicide attempt or self-injury within 52 weeks prior to obtaining informed consent.\n* Patients with a history of or a complication of convulsive disorder such as epilepsy.\n* Patients with a history of or a complication of organic brain disorder including cerebrovascular disease.\n* Patients with a history or a complication of granulocytopenia or agranulocytosis.\n* Patients who have received electro-convulsive therapy (ECT) within 12 weeks prior to obtaining informed consent."}, 'identificationModule': {'nctId': 'NCT02220712', 'briefTitle': 'A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'orgStudyIdInfo': {'id': '031-13-005'}, 'secondaryIdInfos': [{'id': 'JapicCTI-142635', 'type': 'OTHER', 'domain': 'Japic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug: OPC-14597 IMD', 'interventionNames': ['Drug: OPC-14597 IMD']}], 'interventions': [{'name': 'OPC-14597 IMD', 'type': 'DRUG', 'description': 'Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals', 'armGroupLabels': ['Drug: OPC-14597 IMD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku Region', 'country': 'Japan'}, {'city': 'Hokkaido Region', 'country': 'Japan'}, {'city': 'Kanto Region', 'country': 'Japan'}, {'city': 'Kinki Region', 'country': 'Japan'}, {'city': 'Kyushu Region', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Jun-ichi Hashimoto, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otsuka Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}