Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial) (NCT03932136) | Clinical Trial Compass
RecruitingPhase 3
Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial)
China300 participantsStarted 2019-07-14
Plain-language 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.
Who can participate
Age range15 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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;
What they're measuring
1
2-year conversion rate of psychosis
Timeframe: 104 weeks
Trial details
NCT IDNCT03932136
SponsorShanghai Jiao Tong University School of Medicine