ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01716858
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Kenji Hashimoto, 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia
Study Start Date : October 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A single-arm study Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract



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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

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

Additional Information:
Publications of Results:
Responsible Party: Kenji Hashimoto, Sulforaphane for Schizophrenia, Chiba University
ClinicalTrials.gov Identifier: NCT01716858     History of Changes
Other Study ID Numbers: Chiba_SFN_Openstudy2012
First Posted: October 30, 2012    Key Record Dates
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