A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Negative Symptoms and Cognition Impairment of Schizophrenia Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change of clinical symptoms by PANSS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants and researchers are blind to treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet The Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia;
- •First onset or duration of illness less than 30 years with current symptoms in a stable condition;
- •Male and female aged 18 to 50 years;
- •Total score greater than or equal to 20 on the sum of the seven items constituting the Positive and Negative Syndrome Scale (PANSS) negative symptoms; an item of PANSS negative symptoms >3 scores;
- •Signed the study consent for participation.
排除标准
- •has a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders;
- •has a history of traumatic brain injury, seizures, or other known neurological diseases of the central nervous system;
- •taking antidepressants, stimulants, mood stabilizers, or received modified electroconvulsive therapy (MECT) or rTMS during the past three months;
- •having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed during the trial;
- •taking dementia-related drugs, minocycline, and other drugs that may affect cognitive function;
- •Laboratory tests indicated significant abnormalities in blood routine, liver and kidney function, or other metabolic results;
- •pregnant or lactating women.
研究组 & 干预措施
placebo
The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.
干预措施: placebo (Dietary Supplement)
sulforaphane
The goal of the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia.
干预措施: Sulforaphane (Drug)
结局指标
主要结局
Change of clinical symptoms by PANSS
时间窗: 24 weeks
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.
Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score
时间窗: 24 weeks
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.
次要结局
- Change of clinical symptoms by SANS(24 weeks)
- side effects by TESS(24 weeks)
- Change of clinical symptoms of CGI(24 weeks)
- Change of psychological, social, and occupational functioning by GAF(24 weeks)
研究者
Renrong Wu
Professor
Central South University