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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01716858
First Posted: October 30, 2012
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenji Hashimoto, Chiba University
  Purpose
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
Schizophrenia Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Kenji Hashimoto, Chiba University:

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

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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716858


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

Additional Information:
Publications:
Responsible Party: Kenji Hashimoto, Sulforaphane for Schizophrenia, Chiba University
ClinicalTrials.gov Identifier: NCT01716858     History of Changes
Other Study ID Numbers: Chiba_SFN_Openstudy2012
First Submitted: October 22, 2012
First Posted: October 30, 2012
Last Update Posted: July 30, 2015
Last Verified: October 2012

Keywords provided by Kenji Hashimoto, Chiba University:
Schizophrenia
Sulforaphane
Psychosis
Cognition
Oxidative stress
Antioxidant
Anti-inflammatory

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents