NCT04521868

A 6-month Study to Evaluate Sulforaphane Effects in Schizophrenia Patients

A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Negative Symptoms and Cognition Impairment of Schizophrenia Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia. This study will compare the sulforaphane with placebo. There is a thirty percent change (less than half) of receiving the placebo. The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.

Detailed description

This study will be carried out in The Third Jiangyin Hospital in China and total of 120 schizophrenia patients with one negative symptom item score of PANSS≥3 will be enrolled into the study. Individuals who participate in the study will be followed for 24 weeks. The changes in clinical symptoms and neurocognitive function will be assessed from baseline (week-0) to week-12, and week-24.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Sulforaphane	Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
DIETARY_SUPPLEMENT	placebo	Placebo is made of starch

Timeline

• Start date: 2020-08-31
• Primary completion: 2022-08-12
• Completion: 2022-08-12
• First posted: 2020-08-21
• Last updated: 2023-04-26

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study