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

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

Tracking Information

• First Submitted Date: August 15, 2016
• First Posted Date: August 26, 2016
• Last Update Posted Date: March 24, 2020
• Actual Study Start Date: December 26, 2016
• Actual Primary Completion Date: May 20, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Phase 2

Study Design

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: Schizophrenia

Intervention

• 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

• 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 *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 22, 2020): 172
• Original Estimated Enrollment (submitted: August 25, 2016): 180
• Actual Study Completion Date: May 20, 2019
• Actual Primary Completion Date: May 20, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02880462
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: Renrong Wu, Central South University
• Original Responsible Party: Same as current
• Current Study Sponsor: Central South University
• Original Study Sponsor: Same as current
• Collaborators: Stanley Medical Research Institute

Investigators

• 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