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

July 28, 2015 updated by: Kenji Hashimoto, Chiba University

Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 260-8670
        • Chiba University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A single-arm study
Dietary supplement: Sulforaphane-rich Broccoli Sprout Extract

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiba University

Investigators

  • Study Chair: Masaomi Iyo, MD, PhD, Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (Estimate)

October 30, 2012

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chiba_SFN_Openstudy2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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