The Influence of Omega-3 Fatty Acid on the Violence of Schizophrenia Patient and the Possible Mechanism
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- psychiatry symptoms of participants as assessed by Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
Investigators plan to explore whether Omega-3 fatty acid have effect on the violent behavior of the schizophrenia patients. Investigators will use PET to explore the influence on serotonin function of the brain to understand the mechanism of how Omega-3 fatty acid works. This study will enroll 100 patients of schizophrenia with violent behavior.Participants will be split into two groups randomly. In one group, participants will receive one pill of placebo per day, and in the other, participants will have one pill of 900mg Omega-3 fatty acid per day. This intervention will last 3 months.At week 0, week 4, week 8 and week 12, some scales will be evaluated. Meanwhile, the density of eicosapentaenoic acid(EPA),docosahexaenoic acid (DHA),noradrenalin(NE), dopamine(DA) and serotonin(5-HT) in blood will be tested.At week 0 and week 12, 10 patients of each group will be randomly selected to have the exam of PET.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the sore of MOAS scale >=4 more than 2 violent behavior in recent 6 months by self repot
排除标准
- •serious diseases,such as cardiovascular diseases,nervous system disease. allergy to fish oil
结局指标
主要结局
psychiatry symptoms of participants as assessed by Positive and Negative Syndrome Scale (PANSS)
时间窗: up to 24 months
change in psychiatry symptoms of participants
the density of 5-HT1A receptor in brain tested by positron emission tomography (PET)
时间窗: up to 24 months
change of the density of 5-HT1A receptor in different groups
violent behavior of Participants as Assessed by Modified Overt Aggression Scale(MOAS)
时间窗: up to 24 months
change in violent behavior of participants
blood level of eicosapentaenoic acid(EPA), docosahexaenoic acid (DHA), noradrenalin(NE), dopamine(DA) and serotonin(5-HT) of participants
时间窗: up to 24 months
change in the blood level of DHA, EPA, 5-HT, DA and NE at baseline, 4 weeks, 8 weeks and 12 weeks
次要结局
未报告次要终点