Randomised Double Blind Placebo Controlled Study of Sodium Nitroprusside Added to Treatment as Usual in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in BPRS score
研究概览
简要总结
In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO is a gas with unique chemistry and influences the release of neurotransmitters, learning, memory and neurodevelopment. Recent studies that investigated the role of NO in patients with schizophrenia found evidence that points to a disruption in NO-mediated neurotransmission in schizophrenia. Accordingly, we believe that the administration of sodium nitroprusside, an NO donor, will ameliorate schizophrenia symptoms.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of schizophrenia
- •Patients in an acute psychotic episode requiring full hospitalization
排除标准
- •Significant medical conditions (heart, kidney, liver, thyroid or neurological diseases, hypovitaminosis B12, hyponatremia)
- •Pregnancy
- •Breastfeeding
- •Previous hypersensitivity to sodium nitroprusside
- •DSM-IV diagnosis of drug abuse or dependence
研究组 & 干预措施
Sodium nitroprusside
干预措施: Sodium nitroprusside (Drug)
Placebo
Glucose solution 5%
干预措施: Glucose solution (Drug)
结局指标
主要结局
Change in BPRS score
时间窗: baseline and up to 4 weeks
Brief Psychiatric Rating Scale
Change in PANSS negative subscale score
时间窗: Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks
Positive and Negative Syndrome Scale
次要结局
- Cognitive assessment(Baseline and after 12 h)
研究者
Jaime Eduardo Cecilio Hallak
Professor
University of Sao Paulo