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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Phase 2 Study of the Effect of add-on Sulforaphane in Treatment of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Dietary Supplement: sulforaphane
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high dose sulforaphane<br>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. | Dietary Supplement: sulforaphane<br>* Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.<br>* Other names: Nutramax;|
| Active Comparator: low dose sulforaphane<br>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. | Dietary Supplement: sulforaphane<br>* Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.<br>* Other names: Nutramax;|
| Placebo Comparator: placebo<br>The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons. | Other: placebo<br>* Placebo is made of starch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects by SAFTEE | The investigators will evaluate side effect by The Systematic Assessment for Treatment Emergent Events (SAFTEE). | 24 weeks | 
| side effects by AIMS | The investigators will evaluate side effect by Abnormal Involuntary Movement Scale (AIMS) | 24 weeks | 
| side effects by BAS | The investigators will evaluate side effect by Barnes Akathisia Rating Scale (BAS). | 24 weeks | 
| side effects by SAS | The investigators will evaluate side effect bySimpson-Angus Scale (SAS). | 24 weeks | 
| 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 | 24 weeks | 
| Change of clinical symptoms of CGI | The change of Clinical Global Impression (CGI) before and after treatment at different follow up point | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, sulforaphane