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

Schizophrenia Clinical Trial

Official title:

Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716858
• Other study ID #: Chiba_SFN_Openstudy2012
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2012
• Last updated: July 28, 2015
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2012
• Source: Chiba University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Dietary Supplement:
• Sulforaphane-rich Broccoli Sprout Extract

Locations

Country	Name	City	State
Japan	Chiba University Hospital	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Chiba University

Country where clinical trial is conducted

Japan, 

References & 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/c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale (PANSS)		Change from baseline in PANSS scores at 8-weeks	Yes
Secondary	Cognition using CogState Research Battery		Change from baseline in the scores of the battery at 8-weeks	Yes

External Links

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