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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract

• Registration Number: NCT01716858
• Lead Sponsor: Chiba University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-10
• Study Start: 2012-10
• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-30
• Primary Completion: 2013-09
• Study Completion: 2014-03
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A single-arm study	Sulforaphane-rich Broccoli Sprout Extract	-

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS)	Change from baseline in PANSS scores at 8-weeks

Secondary Outcome Measures

Name	Time	Method
Cognition using CogState Research Battery	Change from baseline in the scores of the battery at 8-weeks

Trial Locations

Locations (1)

Chiba University Hospital; 🇯🇵 Chiba, Japan