Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
Study NCT ID:
NCT04521868
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2020-08-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 6-month Study to Evaluate Sulforaphane Effects in 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': 'C016766', 'term': 'sulforaphane'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and researchers are blind to treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of clinical symptoms by PANSS', 'timeFrame': '24 weeks', 'description': 'The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point. The PANSS total score ranges from 30-210 points,the higher the score, the worse the symptoms.'}, {'measure': 'Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score', 'timeFrame': '24 weeks', 'description': 'The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure.The MCCB total score is about 50 in healthy participants, patients with schizophrenia are reported to have scores as low as two standard deviations below the mean points; the higher the score, the better the cognition performance.'}], 'secondaryOutcomes': [{'measure': 'side effects by TESS', 'timeFrame': '24 weeks', 'description': 'The investigators will evaluate side effect by Treatment Emergent Symptom Scale. It is consisted of behavioural toxicity, laboratory abnormalities, nervous system, automatic nervous system, cardiovascular system and six other aspects, was used to evaluate adverse drug reactions based on the scores, ranging from 0 to 4 (the higher the score, the more serious the adverse reactions).'}, {'measure': 'Change of clinical symptoms by SANS', 'timeFrame': '24 weeks', 'description': 'The change of Scale for Assessment of Negative Symptoms (SANS) to evaluate negative symptoms before and after treatment at different time point. It measures 25 items of negative symptoms across 5 categories: affective blunting, alogia, avolition-apathy, anhedonia-asociality, and inattention, ranging from 0-120.'}, {'measure': 'Change of clinical symptoms of CGI', 'timeFrame': '24 weeks', 'description': 'The change of Clinical Global Impression (CGI) before and after treatment at different follow up point. Its assess Severity of Illness (CGI-S), Global Improvement (CGI-I), and Efficacy Index (CGI-E). CGI-S is a 7-point scale, the higher score means the more severe the illness; CGI-I is a 7 point scale, the higher score means the less improved symptoms after treatment; CGI-E is is a 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication and associated side effects.'}, {'measure': 'Change of psychological, social, and occupational functioning by GAF', 'timeFrame': '24 weeks', 'description': 'The change of Global Assessment of Functioning (GAF) Scale before and after treatment at different follow up point.ranging from 0 to 100.The higher scores means the better functioning performance.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'sulforaphane'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '39832347', 'type': 'DERIVED', 'citation': 'Huang J, Chen A, Jin H, Liu F, Hei G, Teng Z, Xiao J, Wu R, Zhao J, Davis JM, Shao P, Smith RC. Efficacy and Safety of Sulforaphane Added to Antipsychotics for the Treatment of Negative Symptoms of Schizophrenia: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Jan 20;86(1):24m15272. doi: 10.4088/JCP.24m15272.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia.\n\nThis study will compare the sulforaphane with placebo. There is a thirty percent change (less than half) of receiving the placebo. The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.', 'detailedDescription': 'This study will be carried out in The Third Jiangyin Hospital in China and total of 120 schizophrenia patients with one negative symptom item score of PANSS≥3 will be enrolled into the study. Individuals who participate in the study will be followed for 24 weeks. The changes in clinical symptoms and neurocognitive function will be assessed from baseline (week-0) to week-12, and week-24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Meet The Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia;\n2. First onset or duration of illness less than 30 years with current symptoms in a stable condition;\n3. Male and female aged 18 to 50 years;\n4. Total score greater than or equal to 20 on the sum of the seven items constituting the Positive and Negative Syndrome Scale (PANSS) negative symptoms; an item of PANSS negative symptoms \\>3 scores;\n5. Signed the study consent for participation.\n\nExclusion Criteria:\n\n1. has a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders;\n2. has a history of traumatic brain injury, seizures, or other known neurological diseases of the central nervous system;\n3. taking antidepressants, stimulants, mood stabilizers, or received modified electroconvulsive therapy (MECT) or rTMS during the past three months;\n4. having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed during the trial;\n5. taking dementia-related drugs, minocycline, and other drugs that may affect cognitive function;\n6. Laboratory tests indicated significant abnormalities in blood routine, liver and kidney function, or other metabolic results;\n7. pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT04521868', 'briefTitle': 'A 6-month Study to Evaluate Sulforaphane Effects in Schizophrenia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Negative Symptoms and Cognition Impairment of Schizophrenia Patients', 'orgStudyIdInfo': {'id': 'Jiangyin-Sulforaphane'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sulforaphane', 'description': 'The goal of the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia.', 'interventionNames': ['Drug: Sulforaphane']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Sulforaphane', 'type': 'DRUG', 'otherNames': ['Nutramax'], 'description': 'Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.', 'armGroupLabels': ['sulforaphane']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo is made of starch', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Second Xiangya Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Renrong Wu, M.D Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Renrong Wu', 'investigatorAffiliation': 'Central South University'}}}}