PMID- 32436318 OWN - NLM STAT- MEDLINE DCOM- 20211022 LR - 20220531 IS - 1751-7893 (Electronic) IS - 1751-7885 (Linking) VI - 15 IP - 3 DP - 2021 Jun TI - Decreasing risk of psychosis by sulforaphane study protocol for a randomized, double-blind, placebo-controlled, clinical multi-centre trial. PG - 585-594 LID - 10.1111/eip.12988 [doi] AB - AIM: A growing number of studies suggest a role of neuroinflammation and oxidative stress in the pathophysiology of psychosis. Sulforaphane (SFN), a natural compound extracted from cruciferous vegetables, has shown anti-inflammatory and anti-oxidative effects which imply a potential effect on decreasing the risk of psychosis. However, there is no study testing the efficacy of SFN for this purpose. It's necessary to evaluate its efficacy on individuals at clinical high risk (CHR) for psychosis. METHODS: This is a randomized, double-blind, placebo-controlled, multi-centre trial. A total of 300 CHR subjects will be identified in the course of face-to-face interviews using the Structured Interview for Prodromal Syndromes. All participants will be randomly allocated to SFN group (n = 150) or placebo group (n = 150). The study duration includes an intervention for 52 consecutive weeks, and additional 1-year follow-up. RESULTS: The primary outcome is 2-year conversion rate of psychosis. Secondary outcomes include 1-year conversion rate of psychosis, the severity and duration of prodromal symptoms, predictive risk of psychosis conversion, neurocognitive functioning and peripheral blood biomarkers of inflammation, oxidative stress and metabolism. Safety monitoring will be performed using scales for side effect, serious adverse events recording, and laboratory tests. CONCLUSION: This trial is expected to clarify the efficacy of SFN in improving prodromal symptoms, and its role in decreasing the risk and conversion rate of psychosis among CHR subjects. The results will also provide solid evidence about the efficacy and safety of SFN in CHR population. Potential challenges and their solutions in performing the present trial are discussed. CI - (c) 2020 John Wiley & Sons Australia, Ltd. FAU - Li, Zhixing AU - Li Z AUID- ORCID: 0000-0002-2889-5059 AD - Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China. FAU - Zhang, Tianhong AU - Zhang T AD - Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China. FAU - Xu, Lihua AU - Xu L AUID- ORCID: 0000-0002-2237-9336 AD - Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China. FAU - Wei, Yanyan AU - Wei Y AD - Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China. FAU - Tang, Yingying AU - Tang Y AD - Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China. FAU - Hu, Qiang AU - Hu Q AD - Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China. FAU - Liu, Xiaohua AU - Liu X AD - Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China. FAU - Li, Xiaolong AU - Li X AD - Shenzhen R&D Center, Shenzhen Fushan Biotech Co., Ltd., Shenzhen, PR China. FAU - Davis, John AU - Davis J AD - Department of Psychiatry, College of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA. AD - Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. AD - Shanghai Jiaotong University School of Medicine, Shanghai, PR China. FAU - Smith, Robert AU - Smith R AD - Department of Psychiatry, New York University School of Medicine, New York, New York, USA. AD - Nathan Kline Institute for Psychiatric Research, Orangeburg, New York, USA. AD - Shanghai Jiaotong University School of Medicine, Shanghai, PR China. FAU - Jin, Hua AU - Jin H AD - Department of Psychiatry, University of California San Diego, San Diego, California, USA. AD - VA San Diego Healthcare System, San Diego, California, USA. FAU - Wang, Jijun AU - Wang J AD - Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China. AD - CAS Center for Excellence in Brain Science and Intelligence Technology (CEBSIT), Chinese Academy of Science, Shanghai, PR China. AD - Institute of Psychology and Behavioral Science, Shanghai Jiao Tong University, Shanghai, PR China. LA - eng PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20200521 PL - Australia TA - Early Interv Psychiatry JT - Early intervention in psychiatry JID - 101320027 RN - 0 (Isothiocyanates) RN - 0 (Sulfoxides) RN - GA49J4310U (sulforaphane) SB - IM MH - Double-Blind Method MH - Humans MH - Isothiocyanates MH - Multicenter Studies as Topic MH - Prodromal Symptoms MH - *Psychotic Disorders/drug therapy MH - Randomized Controlled Trials as Topic MH - Risk Factors MH - Sulfoxides OTO - NOTNLM OT - clinical high-risk syndrome of psychosis OT - conversion rate OT - prodromal psychosis OT - randomized controlled trial OT - sulforaphane EDAT- 2020/05/22 06:00 MHDA- 2022/06/01 06:00 CRDT- 2020/05/22 06:00 PHST- 2020/03/26 00:00 [revised] PHST- 2019/08/22 00:00 [received] PHST- 2020/04/28 00:00 [accepted] PHST- 2020/05/22 06:00 [pubmed] PHST- 2022/06/01 06:00 [medline] PHST- 2020/05/22 06:00 [entrez] AID - 10.1111/eip.12988 [doi] PST - ppublish SO - Early Interv Psychiatry. 2021 Jun;15(3):585-594. doi: 10.1111/eip.12988. Epub 2020 May 21.