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Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial)
Sponsor: Shanghai Jiao Tong University School of Medicine
Summary
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. 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.
Official title: Decreasing Risk of Psychosis by Sulforaphane: Study Protocol for a Randomized, Double-blind, Placebo-controlled, Clinical Multicenter Trial (DROPS Trial)
Key Details
Gender
All
Age Range
15 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2019-07-14
Completion Date
2026-12-31
Last Updated
2023-10-31
Healthy Volunteers
No
Conditions
Interventions
Sulforaphane
Sulforaphane (SFN) is a natural compound extracts from cruciferous vegetables, especially broccoli, with cytoprotective, anti-inflammatory, and antioxidant effects.
Placebo
The placebo is safe, with no therapeutical effect, and has same appearance and similar smell and taste with active tablet.
Locations (9)
Guangzhou Psychiatric Hospital
Guangzhou, Guangdong, China
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Suzhou Psychiatric Hospital
Suzhou, Jiangsu, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Shanghai Xuhui District Mental Health Center
Shanghai, Shanghai Municipality, China
Shanghai Pudong Nanhui Mental Health Center
Shanghai, Shanghai Municipality, China
Shenzhen Kangning Hospital
Shenzhen, Shenzhen, China
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China