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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
Placebo is made of starch
Second Xiangya Hospital
Changsha, Hunan, China
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. The PANSS total score ranges from 30-210 points,the higher the score, the worse the symptoms.
Time frame: 24 weeks
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.The MCCB total score is about 50 in healthy participants, patients with schizophrenia are reported to have scores as low as two standard deviations below the mean points; the higher the score, the better the cognition performance.
Time frame: 24 weeks
side effects by TESS
The investigators will evaluate side effect by Treatment Emergent Symptom Scale. It is consisted of behavioural toxicity, laboratory abnormalities, nervous system, automatic nervous system, cardiovascular system and six other aspects, was used to evaluate adverse drug reactions based on the scores, ranging from 0 to 4 (the higher the score, the more serious the adverse reactions).
Time frame: 24 weeks
Change of clinical symptoms by SANS
The change of Scale for Assessment of Negative Symptoms (SANS) to evaluate negative symptoms before and after treatment at different time point. It measures 25 items of negative symptoms across 5 categories: affective blunting, alogia, avolition-apathy, anhedonia-asociality, and inattention, ranging from 0-120.
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. Its assess Severity of Illness (CGI-S), Global Improvement (CGI-I), and Efficacy Index (CGI-E). CGI-S is a 7-point scale, the higher score means the more severe the illness; CGI-I is a 7 point scale, the higher score means the less improved symptoms after treatment; CGI-E is is a 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication and associated side effects.
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Time frame: 24 weeks
Change of psychological, social, and occupational functioning by GAF
The change of Global Assessment of Functioning (GAF) Scale before and after treatment at different follow up point.ranging from 0 to 100.The higher scores means the better functioning performance.
Time frame: 24 weeks