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

NCT ID: NCT01716858

Last Updated: 2015-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-03-31

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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A single-arm study

Group Type EXPERIMENTAL

Sulforaphane-rich Broccoli Sprout Extract

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Sulforaphane-rich Broccoli Sprout Extract

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiba University

OTHER

Sponsor Role lead

Responsible Party

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Kenji Hashimoto

Sulforaphane for Schizophrenia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Masaomi Iyo, MD, PhD

Role: STUDY_CHAIR

Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine

Locations

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Chiba University Hospital

Chiba, Chiba, Japan

Site Status

Countries

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Japan

References

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Shiina A, Kanahara N, Sasaki T, Oda Y, Hashimoto T, Hasegawa T, Yoshida T, Iyo M, Hashimoto K. An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients with Schizophrenia. Clin Psychopharmacol Neurosci. 2015 Apr 30;13(1):62-7. doi: 10.9758/cpn.2015.13.1.62.

Reference Type RESULT
PMID: 25912539 (View on PubMed)

Related Links

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Other Identifiers

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Chiba_SFN_Openstudy2012

Identifier Type: -

Identifier Source: org_study_id

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