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RECRUITING
NCT03932136
PHASE3

Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial)

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Sulforaphane

Sulforaphane (SFN) is a natural compound extracts from cruciferous vegetables, especially broccoli, with cytoprotective, anti-inflammatory, and antioxidant effects.

COMBINATION_PRODUCT

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