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

This study has been completed.
Information provided by (Responsible Party):
Kenji Hashimoto, Chiba University Identifier:
First received: October 22, 2012
Last updated: July 28, 2015
Last verified: October 2012
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.

Condition Intervention Phase
Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia

Resource links provided by NLM:

Further study details as provided by Chiba University:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change from baseline in PANSS scores at 8-weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cognition using CogState Research Battery [ Time Frame: Change from baseline in the scores of the battery at 8-weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: October 2012
Study Completion Date: March 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A single-arm study Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract


Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01716858

Chiba University Hospital
Chiba, Japan, 260-8670
Sponsors and Collaborators
Chiba University
Study Chair: Masaomi Iyo, MD, PhD Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
  More Information

Additional Information:
Responsible Party: Kenji Hashimoto, Sulforaphane for Schizophrenia, Chiba University Identifier: NCT01716858     History of Changes
Other Study ID Numbers: Chiba_SFN_Openstudy2012
Study First Received: October 22, 2012
Last Updated: July 28, 2015
Health Authority: Japan: Institutional Review Board

Keywords provided by Chiba University:
Oxidative stress

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Anticarcinogenic Agents
Antineoplastic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on November 24, 2015