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Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial)

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    v7
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2025v6 Show 4 more changesShow less
    • Study sites: 8 to 9
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    • Study description shortened, about 87 words
    • Collaborators: 8 to 9
  3. Primary and study completion dates: Dec 30, 2021 to Dec 31, 2024
    • Study description expanded, about 87 words
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Primary completion date: Sep 30, 2020 to Dec 30, 2021v3 Show 9 more changesShow less
    • Start date: Apr 1, 2018 to Jul 14, 2019
    • Primary endpoints: 2 to 1
    • Study sites: 6 to 8
    • Study completion date: Dec 30, 2020 to Dec 30, 2021
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints: 6 to 9
    • Study description expanded, about 662 words
    • Collaborators: 6 to 8
    • Publications: 11 to 12
  6. Study description expanded, about 23 words
    • Study sites revised (6)
    • Collaborators expanded, about 32 words
    • Eligibility criteria shortened, about 4 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03932136
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Collaborators: Shanghai Xuhui District Mental Health Center, Shanghai Pudong New Area Nanhui Mental Health Center, Suzhou Psychiatric Hospital, Second Xiangya Hospital of Central South University, Guangzhou Psychiatric Hospital, Shenzhen Fushan Biotech Co., Ltd., Tianjin Anding Hospital, The First Affiliated Hospital of Zhengzhou University, Shenzhen Kangning Hospital
Conditions
(from sponsor)		 Clinical High Risk Syndrome of Psychosis
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov