Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-02 @ 10:58 PM
Study NCT ID:
NCT01716858
Status:
COMPLETED
Last Update Posted:
2015-07-30
First Post:
2012-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-28', 'studyFirstSubmitDate': '2012-10-22', 'studyFirstSubmitQcDate': '2012-10-29', 'lastUpdatePostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': 'Change from baseline in PANSS scores at 8-weeks'}], 'secondaryOutcomes': [{'measure': 'Cognition using CogState Research Battery', 'timeFrame': 'Change from baseline in the scores of the battery at 8-weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Sulforaphane', 'Psychosis', 'Cognition', 'Oxidative stress', 'Antioxidant', 'Anti-inflammatory'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '25912539', 'type': 'RESULT', 'citation': 'Shiina A, Kanahara N, Sasaki T, Oda Y, Hashimoto T, Hasegawa T, Yoshida T, Iyo M, Hashimoto K. An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients with Schizophrenia. Clin Psychopharmacol Neurosci. 2015 Apr 30;13(1):62-7. doi: 10.9758/cpn.2015.13.1.62.'}], 'seeAlsoLinks': [{'url': 'http://www.cpn.or.kr/journal/view.html?volume=13&number=1&spage=62', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Accumulating evidence suggests a role of oxidative stress in the pathophysiology of schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as the electrophilic responsive element or antioxidant responsive element. Recently, we reported that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia for DSM-IV TR criteria\n* Patients are treated with an antipsychotic drug (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone).\n* Patients are stable for 4-weeks for antipsychotic medication.\n\nExclusion Criteria:\n\n* Patients treated with clozapine\n* Patients treated with two or more antipsychotic drugs\n* Pregnant or breast-feeding women\n* Patients treated with sulforaphane for more than 8-weeks in the past.'}, 'identificationModule': {'nctId': 'NCT01716858', 'briefTitle': 'An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Chiba University'}, 'officialTitle': 'Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia', 'orgStudyIdInfo': {'id': 'Chiba_SFN_Openstudy2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A single-arm study', 'interventionNames': ['Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract']}], 'interventions': [{'name': 'Sulforaphane-rich Broccoli Sprout Extract', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['A single-arm study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '260-8670', 'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Chiba University Hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}], 'overallOfficials': [{'name': 'Masaomi Iyo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiba University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sulforaphane for Schizophrenia', 'investigatorFullName': 'Kenji Hashimoto', 'investigatorAffiliation': 'Chiba University'}}}}