An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia

Study Overview
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Brief Summary
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Accumulating evidence suggests a role of oxidative stress in the pathophysiology of schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as the electrophilic responsive element or antioxidant responsive element. Recently, we reported that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with schizophrenia.

Official Title
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Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schizophrenia for DSM-IV TR criteria Patients are treated with an antipsychotic drug (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone). Patients are stable for 4-weeks for antipsychotic medication. Exclusion Criteria: Patients treated with clozapine Patients treated with two or more antipsychotic drugs Pregnant or breast-feeding women Patients treated with sulforaphane for more than 8-weeks in the past.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A single-arm study<br> | Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) |  | Change from baseline in PANSS scores at 8-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition using CogState Research Battery |  | Change from baseline in the scores of the battery at 8-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Sulforaphane, Psychosis, Cognition, Oxidative stress, Antioxidant, Anti-inflammatory