Reducing the risk of psychosis with sulforaphane

Decreasing Risk of Psychosis by Sulforaphane: Study Protocol for a Randomized, Double-blind, Placebo-controlled, Clinical Multicenter Trial (DROPS Trial)

This study is testing if a compound found in broccoli called sulforaphane can help people at high risk of developing psychosis avoid it over two years.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 15 Years to 45 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 9 sites (Guangzhou, Guangdong and 8 other locations)
• Trial ID: NCT03932136 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of sulforaphane in reducing the risk of developing psychosis in individuals identified as being at clinical high risk. A total of 300 participants will be randomly assigned to receive either sulforaphane or a placebo for 52 weeks, followed by a one-year follow-up. The primary outcome is the conversion rate to psychosis over two years, while secondary outcomes include the severity of prodromal symptoms and various biomarkers. The study is conducted across eight research centers in China, ensuring a diverse participant pool.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 15 to 45 who meet the criteria for clinical high risk of psychosis and have not previously been treated with antipsychotics or mood stabilizers.

Not a fit: Patients with a history of schizophrenia or other psychotic disorders, severe physical diseases, or significant intellectual disabilities may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a novel preventive treatment for individuals at high risk of developing psychosis.

How similar studies have performed: While the approach of using sulforaphane is novel, similar studies targeting the prevention of psychosis in at-risk populations have shown promising results.

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.).

Where this trial is running

Guangzhou, Guangdong and 8 other locations

• Guangzhou Psychiatric Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• the First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• Suzhou Psychiatric Hospital — Suzhou, Jiangsu, China (Recruiting)
• Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai Xuhui District Mental Health Center — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanghai Pudong Nanhui Mental Health Center — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shenzhen Kangning Hospital — Shenzhen, Shenzhen, China (Recruiting)
• Tianjin Anding Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Tianhong Zhang, PhD — Shanghai Mental Health Center
• Study coordinator: Jijun Wang, PhD

Conditions Clinical High Risk Syndrome of Psychosis