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A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
sulforaphane
placebo
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, sulforaphane

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Meet The Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia
  2. First onset or duration of illness less than 3 years with current symptoms exacerbation
  3. Hospitalized in an acute episode (first hospitalization), or subsequent hospitalization or acute relapse)
  4. Male and female with aged 18 to 50 years
  5. PANSS total >=75 at 2 weeks. .
  6. Signed the study consent for participation

Exclusion Criteria:

  1. having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;
  2. having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
  3. taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;
  4. having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
  5. the routine blood tests showing abnormal renal, liver function or other metabolic results .
  6. pregnant or lactating women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    high dose sulforaphane

    low dose sulforaphane

    placebo

    Arm Description

    The goal of the study is to investigate whether adding high doses of sulforaphane will benefit the clinical symptoms and cognitive function in individuals who have schizophrenia.

    The goal of the study is to investigate whether adding low doses of sulforaphane will benefit the clinical symptoms and cognitive function in individuals who have schizophrenia.

    The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.

    Outcomes

    Primary Outcome Measures

    Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score
    The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure.

    Secondary Outcome Measures

    side effects by SAFTEE
    The investigators will evaluate side effect by The Systematic Assessment for Treatment Emergent Events (SAFTEE).
    side effects by AIMS
    The investigators will evaluate side effect by Abnormal Involuntary Movement Scale (AIMS)
    side effects by BAS
    The investigators will evaluate side effect by Barnes Akathisia Rating Scale (BAS).
    side effects by SAS
    The investigators will evaluate side effect bySimpson-Angus Scale (SAS).
    Change of clinical symptoms by PANSS
    The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point
    Change of clinical symptoms of CGI
    The change of Clinical Global Impression (CGI) before and after treatment at different follow up point

    Full Information

    First Posted
    August 15, 2016
    Last Updated
    March 22, 2020
    Sponsor
    Central South University
    Collaborators
    Stanley Medical Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02880462
    Brief Title
    A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Schizophrenia
    Official Title
    Phase 2 Study of the Effect of add-on Sulforaphane in Treatment of Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 26, 2016 (Actual)
    Primary Completion Date
    May 20, 2019 (Actual)
    Study Completion Date
    May 20, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Central South University
    Collaborators
    Stanley Medical Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of the study is to investigate whether adding different doses of sulforaphane will benefit the clinical symptoms and cognitive function in individuals who have schizophrenia. This 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.
    Detailed Description
    This study will be carried out in six mental health institutes in China and total of 180 patients with first-episode or early onset schizophrenia will be enrolled into the study. The mental health institute at the Second Xiangya Hospital, Central South University. 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-2) to week-6 (acute phase), and week-12 to week-24 (maintenance phase).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    schizophrenia, sulforaphane

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Participants and researchers are blind to treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
    Allocation
    Randomized
    Enrollment
    172 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    high dose sulforaphane
    Arm Type
    Active Comparator
    Arm Description
    The goal of the study is to investigate whether adding high doses of sulforaphane will benefit the clinical symptoms and cognitive function in individuals who have schizophrenia.
    Arm Title
    low dose sulforaphane
    Arm Type
    Active Comparator
    Arm Description
    The goal of the study is to investigate whether adding low doses of sulforaphane will benefit the clinical symptoms and cognitive function in individuals who have schizophrenia.
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    sulforaphane
    Other Intervention Name(s)
    Nutramax
    Intervention Description
    Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    Placebo is made of starch
    Primary Outcome Measure Information:
    Title
    Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score
    Description
    The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    side effects by SAFTEE
    Description
    The investigators will evaluate side effect by The Systematic Assessment for Treatment Emergent Events (SAFTEE).
    Time Frame
    24 weeks
    Title
    side effects by AIMS
    Description
    The investigators will evaluate side effect by Abnormal Involuntary Movement Scale (AIMS)
    Time Frame
    24 weeks
    Title
    side effects by BAS
    Description
    The investigators will evaluate side effect by Barnes Akathisia Rating Scale (BAS).
    Time Frame
    24 weeks
    Title
    side effects by SAS
    Description
    The investigators will evaluate side effect bySimpson-Angus Scale (SAS).
    Time Frame
    24 weeks
    Title
    Change of clinical symptoms by PANSS
    Description
    The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point
    Time Frame
    24 weeks
    Title
    Change of clinical symptoms of CGI
    Description
    The change of Clinical Global Impression (CGI) before and after treatment at different follow up point
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet The Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia First onset or duration of illness less than 3 years with current symptoms exacerbation Hospitalized in an acute episode (first hospitalization), or subsequent hospitalization or acute relapse) Male and female with aged 18 to 50 years PANSS total >=75 at 2 weeks. . Signed the study consent for participation Exclusion Criteria: having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders; having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system; taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment; having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting; the routine blood tests showing abnormal renal, liver function or other metabolic results . pregnant or lactating women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jianjun Ou, M.D Ph.D
    Organizational Affiliation
    Central South University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Renrong Wu, M.D Ph.D
    Organizational Affiliation
    Central South University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jingping Zhao, M.D Ph.D
    Organizational Affiliation
    Central South University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Hua Jin, M.D Ph.D
    Organizational Affiliation
    University of California, San Diego
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    15207938
    Citation
    Selley ML. Increased (E)-4-hydroxy-2-nonenal and asymmetric dimethylarginine concentrations and decreased nitric oxide concentrations in the plasma of patients with major depression. J Affect Disord. 2004 Jun;80(2-3):249-56. doi: 10.1016/S0165-0327(03)00135-6.
    Results Reference
    background
    PubMed Identifier
    20974172
    Citation
    Bitanihirwe BK, Woo TU. Oxidative stress in schizophrenia: an integrated approach. Neurosci Biobehav Rev. 2011 Jan;35(3):878-93. doi: 10.1016/j.neubiorev.2010.10.008. Epub 2010 Oct 23.
    Results Reference
    background

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    A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Schizophrenia

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