An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Sulforaphane-rich Broccoli Sprout Extract
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Sulforaphane, Psychosis, Cognition, Oxidative stress, Antioxidant, Anti-inflammatory
Eligibility 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.
Sites / Locations
- Chiba University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A single-arm study
Arm Description
Outcomes
Primary Outcome Measures
Positive and Negative Syndrome Scale (PANSS)
Secondary Outcome Measures
Cognition using CogState Research Battery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01716858
Brief Title
An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia
Official Title
Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiba University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Sulforaphane, Psychosis, Cognition, Oxidative stress, Antioxidant, Anti-inflammatory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A single-arm study
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Sulforaphane-rich Broccoli Sprout Extract
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Time Frame
Change from baseline in PANSS scores at 8-weeks
Secondary Outcome Measure Information:
Title
Cognition using CogState Research Battery
Time Frame
Change from baseline in the scores of the battery at 8-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaomi Iyo, MD, PhD
Organizational Affiliation
Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8670
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25912539
Citation
Shiina A, Kanahara N, Sasaki T, Oda Y, Hashimoto T, Hasegawa T, Yoshida T, Iyo M, Hashimoto K. An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients with Schizophrenia. Clin Psychopharmacol Neurosci. 2015 Apr 30;13(1):62-7. doi: 10.9758/cpn.2015.13.1.62.
Results Reference
result
Links:
URL
http://www.cpn.or.kr/journal/view.html?volume=13&number=1&spage=62
Description
Related Info
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An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia
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