Effects of Reveratrol on Cardiovascular Risk Markers and Cognitive Performance in Patients With Schizophrenia: a Randomized Clinical Trilal
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Assessment of cardiovascular risk will be realized by measurement of cytokine levels, C-reactive protein and cholesterol levels.
研究概览
简要总结
Resveratrol supplementation may improve cardiovascular risk factors and cognitive parameters in patients with schizophrenia taking antipsychotics?
详细描述
Randomized, double-blind, placebo-controlled trial comparing supplementation with resveratrol or placebo in patients diagnosed with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 18-65 years old, diagnosed with schizophrenia according to DSM-IV and ICD-10, which are in clozapine medication for at least 6 months.
排除标准
- •Patients will be excluded from the study:
- •Have a diagnosis of diabetes
- •Use other antipsychotic drugs, clozapine beyond
- •Using medicines for diabetes or dyslipidaemia
- •Accept not participate in any stage of the research.
研究组 & 干预措施
resveratrol
干预措施: resveratrol (Drug)
corn starch
(10 patients) 100mg 2x/day
1 month
干预措施: resveratrol (Drug)
结局指标
主要结局
Assessment of cardiovascular risk will be realized by measurement of cytokine levels, C-reactive protein and cholesterol levels.
时间窗: 1 month
Assessment of cardiovascular risk will be realized by measurement of cytokine levels (IL-12p70, IL-6, IL-10, IL-1b, IL-8 and TNF-α), C-reactive protein and cholesterol levels (total cholesterol, LDL, HDL, triglycerides) in patients with schizophrenia before and after supplementation with resveratrol or placebo.
次要结局
- Cognitive performance will be assessed with a battery of cognitive tests and BPRS (brief psychiatric rating scale) to assess symptoms.(1 month)
研究者
Karine Zortéa
Master
Federal University of Rio Grande do Sul