L-Arginine add-on Treatment for Schizophrenia: A Randomized, Double Blind, Placebo Controlled, Cross Over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change from baseline in Positive and Negative Syndrome Scale
研究概览
简要总结
This study evaluates the addition of L-Arginine to the usual regimen in the treatment of schizophrenia in adults. As a requisite of crossover design, half of the participants started with L-Arginine and the other half with placebo and switched over after a three weeks use and one week of a washout period.
详细描述
L-arginine is the precursor of nitric oxide (NO), a neuromodulator of dopamine, gamma-aminobutyrate (GABA) and glutamate systems. Nitric oxide donors which increase NO levels at the cellular level could improve N-methyl-D-aspartate (NMDA) receptor dysfunction. Using L-arginine could bypass the blocked NMDA receptors and improve the therapeutic efficacy by reversing the dysfunction.
The investigators proposed that using L-Arginine, a dietary supplement in most cultures, might constitute a safe option as an add-on treatment which may display beneficial effects on positive, negative, cognitive and affective symptoms associated with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia-Schizoaffective Disorder
- •Clinical Global Impression >4
- •Able to take oral medication and likely to comply the required evaluations
- •On stable medication regimen for 8 weeks
- •Competent and willing to give informed consent
排除标准
- •Uncontrolled medical illness (renal disease, hepatic, cardiac diseases, gout, asthma, diabetes, sickle cell anemia, low-high blood pressure)
- •History of Myocardial Infarction (MI)
- •History of genital herpes infections/ receiving lysine containing treatments
- •Pregnancy/ lactation
- •Substance related and Addictive Disorders
- •Drugs that might induce hypotension
- •Intolerance to L-arginine and ingredients of placebo or L-arginine capsule
结局指标
主要结局
Change from baseline in Positive and Negative Syndrome Scale
时间窗: baseline and week 3
Evaluating change in Positive and Negative Syndrome Scale between baseline and Week 3, comparing subjects treated with L-Arginine for 3 weeks to subjects treated with placebo for 3 weeks.
次要结局
- Change from baseline in Neuropsychological Test Battery(baseline and week 3)
- Change from baseline in the The Calgary Depression Scale for Schizophrenia(baseline and week 3)
- Change from baseline in Clinical Global Impression - Severity(baseline and week 3)
- Change from baseline in Abnormal Involuntary Movement Scale(baseline and week 3)
- Change from baseline in Uku Side Effects Rating Scale(baseline and week 3)
- Change from baseline in blood pressure(baseline and week 7)
- Change from baseline in respiratory rate(baseline and week 7)
- Change from baseline in heart rate(baseline and week 7)
- Change from baseline in temperature(baseline and week 7)
- Change from baseline in electrocardiogram(baseline and week 7)
- Change from baseline in weight(baseline and week 7)
- Change from baseline in complete blood count(baseline and week 7)
- Change from baseline in alanine aminotransferase(baseline and week 7)
- Change from baseline in aspartate aminotransferase(baseline and week 7)
- Change from baseline in urea(baseline and week 7)
- Change from baseline in alkaline phosphatase(baseline and week 7)
- Change from baseline in creatinine(baseline and week 7)
- Change from baseline in sodium(baseline and week 7)
- Change from baseline in calcium(baseline and week 7)
- Change from baseline in total cholesterol(baseline and week 7)
- Change from baseline in potassium(baseline and week 7)
- Change from baseline in chloride(baseline and week 7)
- Change from baseline in thyroid-stimulating hormone(baseline and week 7)
- Change from baseline in free T4(baseline and week 7)
- Change from baseline in HDL(baseline and week 7)
- Change from baseline in LDL(baseline and week 7)
- Change from baseline in triglycerides(baseline and week 7)
- Change from baseline in human chorionic gonadotropin(baseline and week 7)
研究者
M. Kazim Yazici
Professor of Psychiatry
Hacettepe University