Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT04528095
Status:
UNKNOWN
Last Update Posted:
2020-08-27
First Post:
2020-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090663', 'term': 'Schizophrenia, Treatment-Resistant'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003024', 'term': 'Clozapine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-22', 'studyFirstSubmitDate': '2020-08-12', 'studyFirstSubmitQcDate': '2020-08-22', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'Change from baseline PANSS score at 12 weeks', 'description': '25% or greater change in Positive and Negative Syndrome Scale (PANSS)'}], 'secondaryOutcomes': [{'measure': 'Adverse reactions', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks', 'description': 'The Barnes Akathisia Scale (BAS) (0,14,higher scores mean a worse outcome),'}, {'measure': 'Adverse reactions', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks', 'description': 'Simpson-Angus Extrapyramidal Side Effects Scale (SAS) (0,40,higher scores mean a worse outcome)'}, {'measure': 'Adverse reactions', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks', 'description': 'Abnormal Involuntary Movement Scale (AIMS) (0,42,higher scores mean a worse outcome)'}, {'measure': 'Neurocognitive assessments and social function', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months', 'description': 'The University of California, San Diego (UCSD) Performance- based Skills Assessment-Brief (UPSA-B) (0,100,higher scores mean a better outcome) is used to evaluate the social function,'}, {'measure': 'Neurocognitive assessments and social function', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months', 'description': 'The MATRICS consensus cognitive battery (MCCB) has been widely used to evaluate cognitive deficits in schizophrenia patients(0%,100%,higher scores mean a better outcome)'}, {'measure': 'Clinical assessements', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks', 'description': 'PANSS (30,210,higher scores mean a worse outcome),'}, {'measure': 'Clinical assessements', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks', 'description': 'Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPS) (0,32,higher scores mean a worse outcome),'}, {'measure': 'Clinical assessements', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks', 'description': 'Calgary Depression Scale for Schizophrenia (CDSS) (0,27,higher scores mean a worse outcome)'}, {'measure': 'Clinical assessements', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks', 'description': 'Clinical Global Impression Scale-Severity (CGI-S) (0,7,higher scores mean a worse outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Treatment-resistant', 'Antipsychotics', 'Combination'], 'conditions': ['Treatment-resistant Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The project intends to take treatment-resistant schizophrenia as the research object and uses sequential multiple assignment randomized trial(SMART) design to define the treatment recommendations of different drug regimen for treatment resistant schizophrenia and to determine the physical enhancement regimen for clozapine-resistant schizophrenia and to explore targeted regulation scheme for ultra-resistant schizophrenia.', 'detailedDescription': "This trial is a sequential multiple-assignment RCT design of antipsychotic drugs, planning to recruit 162 people with treatment-resistant schizophrenia followed for 12 months. The study includes three treatment phases and a naturalistic follow-up phase. Participants who meet the response criteria remain on that treatment for the duration of 12-month treatment. If the participants fail the treatment or can't tolerant the side effects, the patient moves to the next phase of the study to receive a new treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. meet the DSM-5 diagnostic criteria for schizophrenia,\n2. be 18-55 years of age,\n3. treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years,\n4. Informed consent.\n\nExclusion Criteria:\n\n1. Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded.\n2. Patients with contraindications to even one of the proposed treatment arms are excluded.\n3. Patients with risks such as extreme agitation, stupor or suicide are excluded.\n4. Female patients with pregnancy or breast-feeding are also excluded.'}, 'identificationModule': {'nctId': 'NCT04528095', 'briefTitle': 'SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia', 'orgStudyIdInfo': {'id': 'TRS-SMART'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clozapine', 'description': 'Clozapine 400 \\~ 600mg/d or plasma concentration \\>350ng/ml', 'interventionNames': ['Drug: Clozapine']}, {'type': 'EXPERIMENTAL', 'label': 'Clozapine+Amisulpride', 'description': 'Clozapine 400 \\~ 600mg/d or plasma concentration \\>350ng/ml Amisulpride 200-800mg/d', 'interventionNames': ['Drug: Clozapine']}, {'type': 'EXPERIMENTAL', 'label': 'Clozapine+Gingke biloba', 'description': 'Clozapine 400 \\~ 600mg/d or plasma concentration \\>350ng/ml Gingke biloba 120-360mg/d', 'interventionNames': ['Drug: Clozapine']}, {'type': 'EXPERIMENTAL', 'label': 'MECT', 'description': 'MECT:The treatment lasted for 4 months,16 times in total', 'interventionNames': ['Device: MECT']}, {'type': 'EXPERIMENTAL', 'label': 'MST', 'description': 'MST:The treatment lasted for 4 months,16 times in total', 'interventionNames': ['Device: MECT']}, {'type': 'EXPERIMENTAL', 'label': 'DBS', 'description': 'Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)', 'interventionNames': ['Device: DBS']}], 'interventions': [{'name': 'Clozapine', 'type': 'DRUG', 'otherNames': ['Clozapine+Amisulpride', 'Clozapine+Gingke biloba'], 'description': 'Clozapine 400 \\~ 600mg/d or plasma concentration \\>350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d', 'armGroupLabels': ['Clozapine', 'Clozapine+Amisulpride', 'Clozapine+Gingke biloba']}, {'name': 'MECT', 'type': 'DEVICE', 'otherNames': ['MST'], 'description': 'MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total', 'armGroupLabels': ['MECT', 'MST']}, {'name': 'DBS', 'type': 'DEVICE', 'description': 'Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)', 'armGroupLabels': ['DBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Dengtang Liu, MD', 'role': 'CONTACT', 'email': 'erliu110@163.com', 'phone': '18017311138'}], 'overallOfficials': [{'name': 'Dengtang Liu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Mental Health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}