Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial)

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.

Conditions

• Clinical High Risk Syndrome of Psychosis

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.

Sponsors & Collaborators

• Shanghai Xuhui District Mental Health Center

  collaborator UNKNOWN

• Shanghai Pudong New Area Nanhui Mental Health Center

  collaborator OTHER

• Suzhou Psychiatric Hospital

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Guangzhou Psychiatric Hospital

  collaborator OTHER_GOV

• Shenzhen Fushan Biotech Co., Ltd.

  collaborator UNKNOWN

• Tianjin Anding Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Shenzhen Kangning Hospital

  collaborator OTHER

• Shanghai Jiao Tong University School of Medicine

  lead OTHER

Principal Investigators

• Jijun Wang, PhD · Shanghai Mental Health Center

• Tianhong Zhang, PhD · Shanghai Mental Health Center

• Hua Jin, PhD · University of California, San Diego

• Xiaolong Li, PhD · Shenzhen Fushan Biotech Co., Ltd.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-14

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• China

Study Locations