Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial)

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Apr 26, 2019

Keywords

ClinConnect Summary

The DROPS Trial is studying whether a natural substance called sulforaphane, found in vegetables like broccoli, can help reduce the risk of developing psychosis in people who are at a clinical high risk for this condition. The study involves 300 participants aged 15 to 45 who meet specific criteria for being at risk for psychosis. To be eligible, participants should not have a history of serious mental health issues, should not have taken certain medications before, and must be able to give consent to participate in the study.

Participants will be randomly assigned to either receive sulforaphane or a placebo (a non-active treatment) for a year. They will also be monitored for another year afterward. Throughout the study, researchers will track the number of participants who develop psychosis, how severe their early symptoms are, and any potential side effects from the treatment. It’s important for participants and their families to know that safety will be closely monitored, and there are specific health conditions that could exclude someone from joining the trial.

Gender

ALL

Eligibility 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.).