Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial)
Decreasing Risk of Psychosis by Sulforaphane: Study Protocol for a Randomized, Double-blind, Placebo-controlled, Clinical Multicenter Trial (DROPS Trial)
Shanghai Jiao Tong University School of Medicine
300 participants
Jul 14, 2019
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria10
- 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.).
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Interventions
Sulforaphane (SFN) is a natural compound extracts from cruciferous vegetables, especially broccoli, with cytoprotective, anti-inflammatory, and antioxidant effects.
The placebo is safe, with no therapeutical effect, and has same appearance and similar smell and taste with active tablet.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT03932136