NCT02916121Unknown不适用
Relationships of One-carbon Cycle Pathway With Psychopathology and Metabolic Abnormalities in Patients With Schizophrenia and Potential Intervention Strategy With Folic Acid and Vitamin B12
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
The investigators study aims are:
- To investigate folate, vitamin B12, and homocysteine levels in patients with schizophrenia.
- To evaluate the relationships among folate, vitamin B12, and homocysteine levels, genetic variants of one-carbon cycle pathway, psychopathology, including positive symptoms, negative symptoms, and cognition, and metabolic abnormalities in patients with schizophrenia.
- For patients with low folate levels, the investigators would like to conduct a 24-week double-blinded, placebo-controlled of folic acid (5 mg/d) and vitamin B12 (500 ug/d) supplementation study to know whether combination of folic acid and vitamin B12 can improve patients' psychopathology or metabolic profiles, and the effects of genetic variants in one-carbon cycle pathway on treatment response.
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)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-65 year-old.
- •Fulfill DSM-IV-TR diagnosis of schizophrenia.
- •Be treated with an antipsychotic agent for at least 6 months or at a stable dose for at least 3 months.
- •Patients with folate deficiency or insufficiency, and PANSS score at least 60 or more in the first phase screening.
- •Folate deficiency and insufficiency (low folate level) are defined as serum folate < 6.8 nmol/L (3 ng/mL) and <= 13.5 nmol/L (6 ng/mL), respectively.
排除标准
- •Medically unstable.
- •Currently taking vitamin supplementation.
- •Pregnancy or lactation.
- •Test positive of urine drug screen
- •Megaloblastic anemia due to folate deficiency;
- •Patients with parkinsonism (score of > 12 on the Simpson-Angus Scale);
- •History of alcohol or other substances use disorder in past 3 months;
- •History of significant neurological illness;
- •Creatine>1.4 ng/dl.
研究组 & 干预措施
folic acid 5 mg/cap
Experimental
folic acid 5 mg/d and vitamin B12 500 ug/d
干预措施: folic acid 5 mg/cap (Dietary Supplement)
placebo
Placebo Comparator
placebo
干预措施: Placebo (Other)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: 24 weeks
We used PANSS to evaluate patients' psychopathology at baseline, week-2, 4, 8, 12, 16, 20, and 24.
次要结局
- CogStat neuropsychological test, including speed of processing, attention, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition(24 weeks)
- blood pressure, mmHg(24 weeks)
- waist circumference, cm(24 weeks)
- triglyceride, mg/dL(24 weeks)
- high density lipoprotein cholesterol (HDL-C), mg/dL(24 weeks)
- fasting blood sugar level, mg/dL(24 weeks)
研究者
研究点 (1)
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