Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-22 @ 4:13 PM
Study NCT ID:
NCT03839251
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2019-01-29', 'studyFirstSubmitQcDate': '2019-02-10', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline PSP(Personal and Social Performance scale) at 12weeks', 'timeFrame': '12weeks', 'description': 'PSP(Personal and Social Performance scale) was measured in baseline and 12week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.'}, {'measure': 'Change from Baseline PSP(Personal and Social Performance scale) at 24weeks', 'timeFrame': '24weeks', 'description': 'PSP(Personal and Social Performance scale) was measured in baseline and 24week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)', 'timeFrame': 'baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks', 'description': 'Clinical global impression-schizophrenia(CGI-S)\n\nThere are Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity in the Clinical global impression-schizophrenia(CGI-S). minimum of each items(Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity) is 1, Maximum is 7. The higher number is worse outcome.'}, {'measure': 'Efficacy Assessment by ERT(Emotional Recognition Test)', 'timeFrame': 'baseline, 24weeks', 'description': 'Emotional Recognition Test(ERT)\n\nminimum of ERT(Emotional Recognition Test) total score is 0, Maximum is 54. The lower number is worse outcome.'}, {'measure': 'Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)', 'timeFrame': 'baseline, 12weeks, 24weeks', 'description': 'Positive and Negative Syndrome Scale(PANSS)\n\nThere are Positive Scale, Negative Scale and General Psychopathology Scale in the PANSS(Positive and Negative Syndrome Scale). minimum of each items(Positive Scale, Negative Scale and General Psychopathology Scale) is 1, Maximum is 7. The higher number is worse outcome.'}, {'measure': 'Efficacy Assessment by self rating scale', 'timeFrame': 'baseline, 12weeks, 24weeks', 'description': 'Subjective Wellbeing under Neuroleptics(SWN-K)\n\nSWN-K(Subjective Wellbeing under Neuroleptics) consists of 20 questions. The minimum score for each question is zero and the maximum score is five. The reverse scoring questions include 1,4,6,9,10,11,12,14,16,17. The total score of the whole item is obtained, and the lower the score, the worse the subjective well-being.'}, {'measure': 'Safety Assessment by Simpson-Angus Scale(SAS)', 'timeFrame': 'baseline, 12weeks, 24weeks', 'description': 'Simpson-Angus Scale(SAS)\n\nminimum of each items(Gait, Arm Dropping, Shoulder Shaking, Elbow Rigidity, Fixation of Position or Wrist Rigidity, Leg Pendulousness, Head Dropping, Glabella Tap, Tremor, Salivation) in the SAS(Simpson-Angus Scale) is 0, Maximum is 4. minimum of total scores in the SAS(Simpson-Angus Scale) is 0, Maximum is 40. The higher number is worse outcome.'}, {'measure': 'Safety Assessment by Barnes Akathisia Rating Scale(BARS)', 'timeFrame': 'baseline, 12weeks, 24weeks', 'description': 'Barnes Akathisia Rating Scale(BARS)\n\nminimum of each items(Objective, Subjective, Distress related to restlessness) in the BAS(Barnes Akathisia Rating Scale) is 0, Maximum is 3. Minimum of Global clinical assessment of akathisia in the BARS is 0, Maximum is 5. The higher number is worse outcome.'}, {'measure': 'Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)', 'timeFrame': 'baseline, 12weeks, 24weeks', 'description': 'Abnormal Involuntary Movement Scale(AIMS)\n\nminimum of each items in the AIMS(Abnormal Involuntary Movement Scale) is 0, Maximum is 4. The higher number is worse outcome.'}, {'measure': 'Safety Assessment by self report scale', 'timeFrame': 'baseline, 12weeks, 24weeks', 'description': 'Visual Analogue Scale(VAS)\n\nminimum of VAS(Visual Analogue Scale) is 0, Maximum is 10. The higher number is worse outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aripiprazole', 'long-acting injection'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients', 'detailedDescription': 'The aim of this study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients diagnosed with schizophrenia according to DSM-5 diagnostic standards\n* men and women aged 19 and under 60\n* a person who is being given an atypical antipsychotic.\n* Patients should be able to reasonably cooperate with the questionnaire to be used for the study\n* a person who fully understands the purpose of the study and signs the consent\n* stable outpatient before screening without changing the volume of antipsychotics for at least two weeks\n\nExclusion Criteria:\n\n* a person who has a serious and unstable physical condition either now or in the past\n* A fertile woman who is currently pregnant or breastfeeding, or who is either unwilling or unable to use acceptable contraception until the clinical trial is complete.\n* a person suffering from severe drug allergies or complex and severe drug reactions\n* Patients who have taken clozapine in the last 60 days\n* subjects showing significant risk of suicide or significant risk of violent behavior based on past history or investigator's judgment"}, 'identificationModule': {'nctId': 'NCT03839251', 'briefTitle': 'Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients', 'orgStudyIdInfo': {'id': 'CUH 2018-02-011-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'abilify maintena', 'description': 'aripiprazole 400mg or 300mg, IM, Once a month', 'interventionNames': ['Drug: abilify maintena']}], 'interventions': [{'name': 'abilify maintena', 'type': 'DRUG', 'otherNames': ['aripiprazole'], 'description': 'aripiprazole 400mg or 300mg, IM, Once a month', 'armGroupLabels': ['abilify maintena']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Department of Psychiatry, Inje University Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Department of Psychiatry, Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Department of Psychiatry, Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Department of Psychiatry, Chonnam National University Medical School', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Department of Psychiatry, Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}], 'overallOfficials': [{'name': 'Young-chul Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Young Chul Chung', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}