NCT03932136

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
8mo left

Started Jul 2019

Longer than P75 for phase_3

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jul 2019Dec 2026

First Submitted

Initial submission to the registry

April 23, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 14, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

6.5 years

First QC Date

April 23, 2019

Last Update Submit

October 28, 2023

Conditions

Clinical High Risk Syndrome of Psychosis

Outcome Measures

Primary Outcomes (1)

  • 2-year conversion rate of psychosis

    The proportion of patients are diagnosed with psychosis in each group

    104 weeks

Secondary Outcomes (9)

  • 1-year conversion rate of psychosis

    52 weeks

  • Severity of prodromal symptoms

    24 weeks, 52 weeks, 104 weeks

  • Severity of psychotic symptom

    24 weeks, 52 weeks, 104 weeks

  • Function

    24 weeks, 52 weeks, 104 weeks

  • Predictive risk of psychosis

    24 weeks, 52 weeks, 104 weeks

  • +4 more secondary outcomes

Other Outcomes (5)

  • Serious adverse events

    the whole process

  • Side-effects of SFN and placebo

    52 weeks

  • Compliance

    24 weeks

  • +2 more other outcomes

Study Arms (2)

SFN group

ACTIVE COMPARATOR

The intervention duration with SFN tablet is 52 consecutive weeks. The dosage is six active tablets (411 μmol GR) per day.

Dietary Supplement: Sulforaphane

Placebo group

PLACEBO COMPARATOR

The intervention duration with placebo tablet is 52 consecutive weeks. The placebo group will be given six placebo tablets per day.

Combination Product: Placebo

Interventions

SulforaphaneDIETARY_SUPPLEMENT

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

Also known as: ZHIYINGUOSU
SFN group
PlaceboCOMBINATION_PRODUCT

The placebo is safe, with no therapeutical effect, and has same appearance and similar smell and taste with active tablet.

Placebo group

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects meet the criteria of CHR according to the Structured Interview for Prodromal Syndromes (SIPS);
  • Subjects will have no history of being medicated with either antipsychotics or mood stabilizers at their first study visit;
  • Age, within the range of 15 to 45 years;
  • Patients and/or their legal guardians for those younger than 18 year old, can understand and sign informed consent, and agree to take the study interventions and complete all visits and examinations.

You may not qualify if:

  • A history of schizophrenia or any other psychotic disorders;
  • Severe physical diseases (ie, cardiac and neurologic diseases, brain trauma, liver and kidney diseases, haematopoietic system and immune system dysfunction), or cancer, or other serious complicated diseases;
  • IQ \< 70 is assessed by Wechsler Adult Intelligence Scale-Revised in China, or a specific of developmental delay or intellectual disability;
  • Abnormal laboratory test results with clinical significance which will affect the safety of participants as determined by the investigator;
  • A past and/or current abuse of alcohol, amphetamine or any other psychostimulants;
  • Suicidal ideation, plan, or suicidal behaviour in the last 3 months;
  • Clinically significant allergic reaction to broccoli;
  • Pregnancy or preparing for pregnancy, and/or lactation;
  • Participation in another clinical trial within the last 30 days.
  • Other conditions that make the candidate subject unsuitable for this study as determined by the principal investigators (eg, aggressive behaviour, safety concerns, difficulty to complete the follow-up, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Guangzhou Psychiatric Hospital

Guangzhou, Guangdong, 510009, China

NOT YET RECRUITING

the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

NOT YET RECRUITING

Second Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Suzhou Psychiatric Hospital

Suzhou, Jiangsu, 201300, China

RECRUITING

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Shanghai Xuhui District Mental Health Center

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Shanghai Pudong Nanhui Mental Health Center

Shanghai, Shanghai Municipality, 201300, China

NOT YET RECRUITING

Shenzhen Kangning Hospital

Shenzhen, Shenzhen, 518118, China

RECRUITING

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Related Publications (12)

  • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

    PMID: 24141714BACKGROUND

  • Miller TJ, McGlashan TH, Rosen JL, Cadenhead K, Cannon T, Ventura J, McFarlane W, Perkins DO, Pearlson GD, Woods SW. Prodromal assessment with the structured interview for prodromal syndromes and the scale of prodromal symptoms: predictive validity, interrater reliability, and training to reliability. Schizophr Bull. 2003;29(4):703-15. doi: 10.1093/oxfordjournals.schbul.a007040.

    PMID: 14989408BACKGROUND

  • Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

    PMID: 3616518BACKGROUND

  • Carrion RE, Cornblatt BA, Burton CZ, Tso IF, Auther AM, Adelsheim S, Calkins R, Carter CS, Niendam T, Sale TG, Taylor SF, McFarlane WR. Personalized Prediction of Psychosis: External Validation of the NAPLS-2 Psychosis Risk Calculator With the EDIPPP Project. Am J Psychiatry. 2016 Oct 1;173(10):989-996. doi: 10.1176/appi.ajp.2016.15121565. Epub 2016 Jul 1.

    PMID: 27363511BACKGROUND

  • Zhang T, Xu L, Tang Y, Li H, Tang X, Cui H, Wei Y, Wang Y, Hu Q, Liu X, Li C, Lu Z, McCarley RW, Seidman LJ, Wang J; SHARP (ShangHai At Risk for Psychosis) Study Group. Prediction of psychosis in prodrome: development and validation of a simple, personalized risk calculator. Psychol Med. 2019 Sep;49(12):1990-1998. doi: 10.1017/S0033291718002738. Epub 2018 Sep 14.

    PMID: 30213278BACKGROUND

  • Nuechterlein KH, Green MF, Kern RS, Baade LE, Barch DM, Cohen JD, Essock S, Fenton WS, Frese FJ 3rd, Gold JM, Goldberg T, Heaton RK, Keefe RS, Kraemer H, Mesholam-Gately R, Seidman LJ, Stover E, Weinberger DR, Young AS, Zalcman S, Marder SR. The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. Am J Psychiatry. 2008 Feb;165(2):203-13. doi: 10.1176/appi.ajp.2007.07010042. Epub 2008 Jan 2.

    PMID: 18172019BACKGROUND

  • Kern RS, Nuechterlein KH, Green MF, Baade LE, Fenton WS, Gold JM, Keefe RS, Mesholam-Gately R, Mintz J, Seidman LJ, Stover E, Marder SR. The MATRICS Consensus Cognitive Battery, part 2: co-norming and standardization. Am J Psychiatry. 2008 Feb;165(2):214-20. doi: 10.1176/appi.ajp.2007.07010043. Epub 2008 Jan 2.

    PMID: 18172018BACKGROUND

  • Addington J, Liu L, Buchy L, Cadenhead KS, Cannon TD, Cornblatt BA, Perkins DO, Seidman LJ, Tsuang MT, Walker EF, Woods SW, Bearden CE, Mathalon DH, McGlashan TH. North American Prodrome Longitudinal Study (NAPLS 2): The Prodromal Symptoms. J Nerv Ment Dis. 2015 May;203(5):328-35. doi: 10.1097/NMD.0000000000000290.

    PMID: 25919383BACKGROUND

  • Li H, Zhang T, Xu L, Tang Y, Cui H, Wei Y, Tang X, Woodberry KA, Shapiro DI, Li C, Seidman LJ, Wang J. A comparison of conversion rates, clinical profiles and predictors of outcomes in two independent samples of individuals at clinical high risk for psychosis in China. Schizophr Res. 2018 Jul;197:509-515. doi: 10.1016/j.schres.2017.11.029. Epub 2017 Dec 26.

    PMID: 29287626BACKGROUND

  • Singh K, Connors SL, Macklin EA, Smith KD, Fahey JW, Talalay P, Zimmerman AW. Sulforaphane treatment of autism spectrum disorder (ASD). Proc Natl Acad Sci U S A. 2014 Oct 28;111(43):15550-5. doi: 10.1073/pnas.1416940111. Epub 2014 Oct 13.

    PMID: 25313065BACKGROUND

  • Bent S, Lawton B, Warren T, Widjaja F, Dang K, Fahey JW, Cornblatt B, Kinchen JM, Delucchi K, Hendren RL. Identification of urinary metabolites that correlate with clinical improvements in children with autism treated with sulforaphane from broccoli. Mol Autism. 2018 May 30;9:35. doi: 10.1186/s13229-018-0218-4. eCollection 2018.

    PMID: 29854372BACKGROUND

  • Li Z, Zhang T, Xu L, Wei Y, Tang Y, Hu Q, Liu X, Li X, Davis J, Smith R, Jin H, Wang J. Decreasing risk of psychosis by sulforaphane study protocol for a randomized, double-blind, placebo-controlled, clinical multi-centre trial. Early Interv Psychiatry. 2021 Jun;15(3):585-594. doi: 10.1111/eip.12988. Epub 2020 May 21.

    PMID: 32436318BACKGROUND

MeSH Terms

Interventions

sulforaphane

Study Officials

  • Jijun Wang, PhD

    Shanghai Mental Health Center

    STUDY DIRECTOR

  • Tianhong Zhang, PhD

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

  • Hua Jin, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

  • Xiaolong Li, PhD

    Shenzhen Fushan Biotech Co., Ltd.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jijun Wang, PhD

CONTACT

+8618616572179jijunwang27@163.com

Zhixing Li, MD

CONTACT

+8613026528898iwisdomlee@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 30, 2019

Study Start

July 14, 2019

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(9)