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Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial)

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ClinicalTrials.gov Identifier: NCT03932136
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : June 17, 2020
Sponsor:
Collaborators:
Shanghai Xuhui District Mental Health Center
Shanghai Pudong 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
Information provided by (Responsible Party):
Jijun Wang, Shanghai Mental Health Center

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.

Condition or disease Intervention/treatment Phase
Clinical High Risk Syndrome of Psychosis Dietary Supplement: Sulforaphane Combination Product: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Decreasing Risk of Psychosis by Sulforaphane: Study Protocol for a Randomized, Double-blind, Placebo-controlled, Clinical Multicenter Trial (DROPS Trial)
Actual Study Start Date : July 14, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SFN group
The intervention duration with SFN tablet is 52 consecutive weeks. The dosage is six active tablets (411 μmol GR) per day.
Dietary Supplement: Sulforaphane
Sulforaphane (SFN) is a natural compound extracts from cruciferous vegetables, especially broccoli, with cytoprotective, anti-inflammatory, and antioxidant effects.
Other Name: ZHIYINGUOSU

Placebo Comparator: Placebo group
The intervention duration with placebo tablet is 52 consecutive weeks. The placebo group will be given six placebo tablets per day.
Combination Product: Placebo
The placebo is safe, with no therapeutical effect, and has same appearance and similar smell and taste with active tablet.




Primary Outcome Measures :
  1. 2-year conversion rate of psychosis [ Time Frame: 104 weeks ]
    The proportion of patients are diagnosed with psychosis in each group


Secondary Outcome Measures :
  1. 1-year conversion rate of psychosis [ Time Frame: 52 weeks ]
    The proportion of patients is diagnosed with psychosis in each group

  2. Severity of prodromal symptoms [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]
    CHR subject's severity of prodromal symptoms is assessed according to the Scale of Prodromal Symptoms (SOPS) based on the SIPS interview

  3. Severity of psychotic symptom [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]
    CHR subject's severity of psychotic symptom is assessed according to the Positive and Negative Syndrome Scale (PANSS)

  4. Function [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]
    CHR subject's overall function is assessed by Global Assessment of Functioning(GAF)

  5. Predictive risk of psychosis [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]
    Predicted risk of psychosis by online psychosis risk calculator.

  6. Neurocognitive functioning [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]
    The MATRICS consensus cognitive battery (MCCB). Original version of the MCCB comprises 10 standardized cognitive measures for seven cognitive domains: speed of processing, attention/vigilance, working memory (verbal and nonverbal), verbal learning, visual learning, reasoning and problem solving, and social cognition. The 7 domain scores and a composite score were used as variables of neurocognition.Our group has previously contributed to the Chinese norms for the MCCB scores of tests. The kappa values for test-retest reliability of the subtests of the Chinese version ranges from 0.73 to 0.94.

  7. Level of inflammation in subjects' peripheral blood [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]
    Detecting expression levels of inflammation-related biomarkers in peripheral blood.

  8. Level of oxidative stress in subjects' peripheral blood [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]
    Detecting expression levels of oxidative stress-related biomarkers in peripheral blood.

  9. Level of metabolism in subjects' peripheral blood [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]
    Detecting expression levels of metabolism-related biomarkers in peripheral blood.


Other Outcome Measures:
  1. Serious adverse events [ Time Frame: the whole process ]
    Serious adverse events

  2. Side-effects of SFN and placebo [ Time Frame: 52 weeks ]
    side-effects of SFN and placebo will be assessed by Systematic Assessment For Treatment Emergent Events (SAFTEE) scale

  3. Compliance [ Time Frame: 24 weeks ]
    Compliance to SFN or placebo assessed using Brief Adherence Rating Scale

  4. Number of CHR subjects who use antidepressants or other medications [ Time Frame: 52 weeks ]
    Usage of antidepressants or other medications

  5. Plasma and urinary measures of GR metabolites [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]
    Plasma and urinary measures of GR metabolites



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects meet the criteria of CHR according to the Structured Interview for Prodromal Syndromes (SIPS);
  2. Subjects will have no history of being medicated with either antipsychotics or mood stabilizers at their first study visit;
  3. Age, within the range of 15 to 45 years;
  4. 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.

Exclusion Criteria:

  1. A history of schizophrenia or any other psychotic disorders;
  2. 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;
  3. IQ < 70 is assessed by Wechsler Adult Intelligence Scale-Revised in China, or a specific of developmental delay or intellectual disability;
  4. Abnormal laboratory test results with clinical significance which will affect the safety of participants as determined by the investigator;
  5. A past and/or current abuse of alcohol, amphetamine or any other psychostimulants;
  6. Suicidal ideation, plan, or suicidal behaviour in the last 3 months;
  7. Clinically significant allergic reaction to broccoli;
  8. Pregnancy or preparing for pregnancy, and/or lactation;
  9. Participation in another clinical trial within the last 30 days.
  10. 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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932136


Contacts
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Contact: Jijun Wang, PhD +8618616572179 jijunwang27@163.com
Contact: Zhixing Li, MD +8613026528898 iwisdomlee@163.com

Locations
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China, Guangdong
Guangzhou Psychiatric Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510009
Contact: Liping Cao    +8613922717196      
China, Henan
the First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, Henan, China
Contact: Xueqin Song         
China, Hunan
Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Renrong Wu, PhD    +8615874179855      
China, Jiangsu
Suzhou Psychiatric Hospital Recruiting
Suzhou, Jiangsu, China, 201300
Contact: Li Hui, PhD    +8618913539878      
China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Jijun Wang, PhD    +8618616572179    jijunwang27@163.com   
Shanghai Xuhui District Mental Health Center Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Guilai Zhan    +8613611952294      
Shanghai Pudong Nanhui Mental Health Center Not yet recruiting
Shanghai, Shanghai, China, 201300
Contact: Jiande Hu    +8613651812720      
China, Tianjin
Tianjin Anding Hospital Recruiting
Tianjin, Tianjin, China
Contact: Jie Li         
Principal Investigator: Meijuan Li         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Shanghai Xuhui District Mental Health Center
Shanghai Pudong 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
Investigators
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Study Director: Jijun Wang, PhD Shanghai Mental Health Center
Principal Investigator: 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.
Publications:

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Responsible Party: Jijun Wang, Professor, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03932136    
Other Study ID Numbers: 03
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents