NCT02880462

A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Schizophrenia

Phase 2 Study of the Effect of add-on Sulforaphane in Treatment of Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (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 different doses of sulforaphane will benefit the clinical 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 six mental health institutes in China and total of 180 patients with first-episode or early onset schizophrenia will be enrolled into the study. The mental health institute at the Second Xiangya Hospital, Central South University. 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-2) to week-6 (acute phase), and week-12 to week-24 (maintenance phase).

Conditions

• Schizophrenia

Interventions

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

Timeline

• Start date: 2016-12-26
• Primary completion: 2019-05-20
• Completion: 2019-05-20
• First posted: 2016-08-26
• Last updated: 2020-03-24