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

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ClinicalTrials.gov Identifier: NCT02880462
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Renrong Wu, Central South University

Tracking Information
First Submitted Date  ICMJE August 15, 2016
First Posted Date  ICMJE August 26, 2016
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE December 26, 2016
Actual Primary Completion Date May 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score [ Time Frame: 24 weeks ]
The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
  • side effects by SAFTEE [ Time Frame: 24 weeks ]
    The investigators will evaluate side effect by The Systematic Assessment for Treatment Emergent Events (SAFTEE).
  • side effects by AIMS [ Time Frame: 24 weeks ]
    The investigators will evaluate side effect by Abnormal Involuntary Movement Scale (AIMS)
  • side effects by BAS [ Time Frame: 24 weeks ]
    The investigators will evaluate side effect by Barnes Akathisia Rating Scale (BAS).
  • side effects by SAS [ Time Frame: 24 weeks ]
    The investigators will evaluate side effect bySimpson-Angus Scale (SAS).
  • Change of clinical symptoms by PANSS [ Time Frame: 24 weeks ]
    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 [ Time Frame: 24 weeks ]
    The change of Clinical Global Impression (CGI) before and after treatment at different follow up point
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Schizophrenia
Official Title  ICMJE Phase 2 Study of the Effect of add-on Sulforaphane in Treatment of Schizophrenia
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participants and researchers are blind to treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Dietary Supplement: sulforaphane
    Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
    Other Name: Nutramax
  • Other: placebo
    Placebo is made of starch
Study Arms  ICMJE
  • Active Comparator: high dose sulforaphane
    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.
    Intervention: Dietary Supplement: sulforaphane
  • Active Comparator: low dose sulforaphane
    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.
    Intervention: Dietary Supplement: sulforaphane
  • Placebo Comparator: placebo
    The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2020)
172
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2016)
180
Actual Study Completion Date  ICMJE May 20, 2019
Actual Primary Completion Date May 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02880462
Other Study ID Numbers  ICMJE Stanley-Sulforaphane
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Renrong Wu, Central South University
Study Sponsor  ICMJE Central South University
Collaborators  ICMJE Stanley Medical Research Institute
Investigators  ICMJE
Principal Investigator: Jianjun Ou, M.D Ph.D Central South University
Principal Investigator: Renrong Wu, M.D Ph.D Central South University
Study Chair: Jingping Zhao, M.D Ph.D Central South University
Principal Investigator: Hua Jin, M.D Ph.D University of California, San Diego
PRS Account Central South University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP