Schizophrenia Clinical Trial
Official title:
Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia
Verified date | October 2012 |
Source | Chiba University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Institutional Review Board |
Study type | Interventional |
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.
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Chiba University Hospital | Chiba |
Lead Sponsor | Collaborator |
---|---|
Chiba University |
Japan,
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
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 |
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