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
|Condition or disease||Intervention/treatment||Phase|
|Clinical High Risk Syndrome of Psychosis||Dietary Supplement: Sulforaphane Combination Product: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 2-year conversion rate of psychosis [ Time Frame: 104 weeks ]The proportion of patients are diagnosed with psychosis in each group
- 1-year conversion rate of psychosis [ Time Frame: 52 weeks ]The proportion of patients is diagnosed with psychosis in each group
- 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
- 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)
- Function [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]CHR subject's overall function is assessed by Global Assessment of Functioning（GAF）
- Predictive risk of psychosis [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]Predicted risk of psychosis by online psychosis risk calculator.
- 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.
- 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.
- 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.
- 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.
- Serious adverse events [ Time Frame: the whole process ]Serious adverse events
- 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
- Compliance [ Time Frame: 24 weeks ]Compliance to SFN or placebo assessed using Brief Adherence Rating Scale
- Number of CHR subjects who use antidepressants or other medications [ Time Frame: 52 weeks ]Usage of antidepressants or other medications
- Plasma and urinary measures of GR metabolites [ Time Frame: 24 weeks, 52 weeks, 104 weeks ]Plasma and urinary measures of GR metabolites
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
|Contact: Jijun Wang, PhDemail@example.com|
|Contact: Zhixing Li, MDfirstname.lastname@example.org|
|Guangzhou Psychiatric Hospital||Not yet recruiting|
|Guangzhou, Guangdong, China, 510009|
|Contact: Liping Cao +8613922717196|
|the First Affiliated Hospital of Zhengzhou University||Not yet recruiting|
|Zhengzhou, Henan, China|
|Contact: Xueqin Song|
|Second Xiangya Hospital of Central South University||Recruiting|
|Changsha, Hunan, China, 410008|
|Contact: Renrong Wu, PhD +8615874179855|
|Suzhou Psychiatric Hospital||Recruiting|
|Suzhou, Jiangsu, China, 201300|
|Contact: Li Hui, PhD +8618913539878|
|Shanghai Mental Health Center||Recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: Jijun Wang, PhD +8618616572179 email@example.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|
|Tianjin Anding Hospital||Recruiting|
|Tianjin, Tianjin, China|
|Contact: Jie Li|
|Principal Investigator: Meijuan Li|
|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.|