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
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, sulforaphane
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
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
NCT ID
NCT02880462
First Posted
August 15, 2016
Last Updated
March 22, 2020
Sponsor
Central South University
Collaborators
Stanley Medical Research Institute
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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