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

NCT01716858 | Completed Phase 2 DMC

• 1 other identifier: Chiba_SFN_Openstudy2012
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Sulforaphane; Psychosis; Cognition; Oxidative stress; Antioxidant; Anti-inflammatory

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

  Change from baseline in PANSS scores at 8-weeks

Secondary Outcomes (1)

• Cognition using CogState Research Battery

  Change from baseline in the scores of the battery at 8-weeks

Study Arms (1)

A single-arm study

EXPERIMENTAL

Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract

Interventions

Sulforaphane-rich Broccoli Sprout Extract DIETARY_SUPPLEMENT

A single-arm study

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiba University: lead

Study Sites (1)

Chiba University Hospital

Chiba, Chiba, 260-8670, Japan

Location

Related Publications (1)

• 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.

  PMID: 25912539 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Masaomi Iyo, MD, PhD

  Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sulforaphane for Schizophrenia

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 30, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2014
• Last Updated: July 30, 2015

Record last verified: 2012-10

Locations

JP (1)