<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01716858</url>
  </required_header>
  <id_info>
    <org_study_id>Chiba_SFN_Openstudy2012</org_study_id>
    <nct_id>NCT01716858</nct_id>
  </id_info>
  <brief_title>An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia</brief_title>
  <official_title>Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiba University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chiba University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Accumulating evidence suggests a role of oxidative stress in the pathophysiology of&#xD;
      schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived&#xD;
      from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels&#xD;
      sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation&#xD;
      of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II&#xD;
      detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as&#xD;
      the electrophilic responsive element or antioxidant responsive element. Recently, we reported&#xD;
      that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist&#xD;
      phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that&#xD;
      SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to&#xD;
      determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with&#xD;
      schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>Change from baseline in PANSS scores at 8-weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognition using CogState Research Battery</measure>
    <time_frame>Change from baseline in the scores of the battery at 8-weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>A single-arm study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sulforaphane-rich Broccoli Sprout Extract</intervention_name>
    <arm_group_label>A single-arm study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Schizophrenia for DSM-IV TR criteria&#xD;
&#xD;
          -  Patients are treated with an antipsychotic drug (risperidone, olanzapine, quetiapine,&#xD;
             perospirone, aripiprazole, blonanserin, paliperidone).&#xD;
&#xD;
          -  Patients are stable for 4-weeks for antipsychotic medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients treated with clozapine&#xD;
&#xD;
          -  Patients treated with two or more antipsychotic drugs&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Patients treated with sulforaphane for more than 8-weeks in the past.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Masaomi Iyo, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chiba University Hospital</name>
      <address>
        <city>Chiba</city>
        <zip>260-8670</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://www.cpn.or.kr/journal/view.html?volume=13&amp;number=1&amp;spage=62</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <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.</citation>
    <PMID>25912539</PMID>
  </results_reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>July 28, 2015</last_update_submitted>
  <last_update_submitted_qc>July 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chiba University</investigator_affiliation>
    <investigator_full_name>Kenji Hashimoto</investigator_full_name>
    <investigator_title>Sulforaphane for Schizophrenia</investigator_title>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Sulforaphane</keyword>
  <keyword>Psychosis</keyword>
  <keyword>Cognition</keyword>
  <keyword>Oxidative stress</keyword>
  <keyword>Antioxidant</keyword>
  <keyword>Anti-inflammatory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sulforaphane</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01716858
org study id: Chiba_SFN_Openstudy2012
nct id: NCT01716858
lead sponsor: 
has dmc: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Positive and Negative Syndrome Scale (PANSS)
time frame: Change from baseline in PANSS scores at 8-weeks
measure: Cognition using CogState Research Battery
time frame: Change from baseline in the scores of the battery at 8-weeks
arm group label: A single-arm study
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Sulforaphane-rich Broccoli Sprout Extract
arm group label: A single-arm study
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Masaomi Iyo, MD, PhD
role: Study Chair
affiliation: Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
facility: 
country: Japan
url: http://www.cpn.or.kr/journal/view.html?volume=13&number=1&spage=62
description: Related Info
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.
PMID: 25912539
responsible party type: Principal Investigator
investigator affiliation: Chiba University
investigator full name: Kenji Hashimoto
investigator title: Sulforaphane for Schizophrenia
mesh term: Schizophrenia
mesh term: Sulforaphane