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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Chiba University
Sponsor:
Information provided by (Responsible Party):
Kenji Hashimoto, Chiba University
ClinicalTrials.gov Identifier:
NCT01716858
First received: October 22, 2012
Last updated: October 29, 2012
Last verified: October 2012
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sulforaphane 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
Estimated Study Completion Date: March 2014
Estimated 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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716858

Contacts
Contact: Akihiro Shiina, MD, PhD +81-43-222-7171 shiina-akihiro@faculty.chiba-u.jp
Contact: Masaomi Iyo, MD, PhD +81-43-222-7171 iyom@faculty.chiba-u.jp

Locations
Japan
Chiba University Hospital Recruiting
Chiba, Japan, 260-8670
Contact: Akihiro Shiina, MD, PhD    +81-43-226-7171    shiina-akihiro@faculty.chiba-u.jp   
Principal Investigator: Kenji Hashimoto, PhD         
Sponsors and Collaborators
Chiba University
Investigators
Study Chair: Masaomi Iyo, MD, PhD Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Kenji Hashimoto, Sulforaphane for Schizophrenia, Chiba University
ClinicalTrials.gov Identifier: NCT01716858     History of Changes
Other Study ID Numbers: Chiba_SFN_Openstudy2012
Study First Received: October 22, 2012
Last Updated: October 29, 2012
Health Authority: Japan: Institutional Review Board

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014