Clinical Comprehensive Intervention on Cognitive Impairment of Schizophrenia Patients With Metabolic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome
研究概览
简要总结
This is a single-center, randomized, parallel-control study conducted in schizophrenic inpatients with metabolic syndrome who have been conducted with olanzapine. The purpose of this study is to evaluate the efficacy and safety of omega-3 polyunsaturated fatty acids, Xbox aerobic exercise and transcranial direct current stimulation( tDCS). Following a screening period, subjects who meet the entry criteria will be randomized to treated with omega-3 polyunsaturated fatty acids1.2mg per day, Xbox aerobic exercise 30min per day and tDCS at 2mA, 20 min(5 session/week) for 12 weeks.
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
- None
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
- •Meets the Diagnostic and Statistical Manual of Mental Disorder,Fifth Edition(DSM-V) criteria for Schizophrenia.
- •Patients have got standard treatment of olanzapine monotherapy for more than 6 months, PANSS baseline ≤
- •Meets the ATP-III criteria for metabolic syndrome.
- •Male or female subjects aged 18-60 years, education level of junior high school for above.
- •The patient fully understand and signed the informed consent form.
排除标准
- •Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases.
- •Pregnant or lactating women and women of childbearing potential throughout the study period; patients who have plans to move to other places within the year.
- •History of diabetes, hyperlipidemia and other metabolic abnormalities.
- •Due to other reasons, the researchers considered it unsuitable to participate in this clinical trial.
研究组 & 干预措施
omega-3 polyunsaturated fatty acids
Patients randomized to the omega-3 polyunsaturated fatty acids will receive treatment with 1200mg per day plus on-going olanzapine.
干预措施: Omega-3 polyunsaturated fatty acids (Drug)
Xbox aerobic exercise
Patients randomized to the Xbox aerobic exercise will do Xbox aerobic exercise 30min per day plus on-going olanzapine.
干预措施: Xbox aerobic exercise (Behavioral)
transcranial direct current stimulation
Patients randomized to the transcranial direct current stimulation will be applied for transcranial direct current stimulation 5 session/week at 2mA, 20min plus on-going olanzapine. The anodal electrode will be placed over the left dorsolateral prefrontal cortex.
干预措施: transcranial direct current stimulation,tDCS (Device)
olanzapine
Patients randomized to the olanzapine will receive conventional treatment-olanzapine.
干预措施: Olanzapine (Drug)
结局指标
主要结局
Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome
时间窗: from baseline to 3 months after treatment
Change in the the MATRICS consensus cognitive battery between randomization
次要结局
- biological index(assessed from baseline to week 24)
- change in the Schizophrenia Quality of Life Scale(SQLS)(assessed from baseline to 3 months after treatment)
- change in the scale of social function in psychosis inpatients(assessed from baseline to 3 months after treatment)
- metabolic indicators(assessed from baseline to week 24)
研究者
Yan CHEN
PI
Shanghai Mental Health Center