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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
172
Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
Placebo is made of starch
Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score
The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure.
Time frame: 24 weeks
side effects by SAFTEE
The investigators will evaluate side effect by The Systematic Assessment for Treatment Emergent Events (SAFTEE).
Time frame: 24 weeks
side effects by AIMS
The investigators will evaluate side effect by Abnormal Involuntary Movement Scale (AIMS)
Time frame: 24 weeks
side effects by BAS
The investigators will evaluate side effect by Barnes Akathisia Rating Scale (BAS).
Time frame: 24 weeks
side effects by SAS
The investigators will evaluate side effect bySimpson-Angus Scale (SAS).
Time frame: 24 weeks
Change of clinical symptoms by PANSS
The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point
Time frame: 24 weeks
Change of clinical symptoms of CGI
The change of Clinical Global Impression (CGI) before and after treatment at different follow up point
Time frame: 24 weeks
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