The Role of Nitric Oxide in Cognition in Schizophrenia; The NOC Study (Nitric Oxide in Cognition)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- The emotionally salient version of the Jumping to Conclusions (JTC) task
研究概览
简要总结
This study evaluates the role of the Nitric Oxide system in cognition in patients with schizophrenia. Participants will be randomised to 2 equal groups and receive either the Nitric Oxide donor molecule glyceryl trinitrate, or a placebo. Performance on several cognitive tasks will be assessed.
详细描述
Nitric oxide [NO] is a gaseous neurotransmitter substance found in the brain. Nitric oxide is integrated with the glutamate system. Glutamate has received considerable attention as an important factor in the cognitive distortions and cognitive impairments that underlie schizophrenia. Deficits in glutamate in schizophrenia may impact upon cognition via the NO system, as glutamate receptors signal by way of NO.
Here the investigators aim to extend knowledge of glutamate-NO systems by directly examining the role of NO in cognition in patients with psychosis. We aim to assess the role of the NO system in cognition, downstream of glutamate and before patients are started on any anti-psychotic medication which perturb brain neurochemistry.
The primary outcome measure is change in a particular style of cognition referred to as 'jumping to conclusions' following the administration of a potent Nitric Oxide donor molecule [glyceryl trinitrate (GTN)], under placebo-controlled, double-blind conditions. This will shed light on the direct role of NO in cognition in psychosis, beyond the glutamate system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-40 years of age
- •Patients undergoing an acute psychotic episode (defined as score > 4 on question P1 of the PANSS positive subscale) requiring full-time hospitalisation according to clinical referral by the relevant mental health service
- •Demonstrates capacity and willing to give informed consent
- •Female participants willing to have a pregnancy test before treatment
- •Currently unmedicated with antipsychotic medication
排除标准
- •Major physical illness
- •Prior history of intolerance to glyceryl trinitrate
- •Homicidal or suicidal
- •Pregnant or breast feeding
研究组 & 干预措施
Glyceryl Trinitrate
Glyceryl Trinitrate, sublingual spray, 3 x 0.4mg dose, once per day for 3 days in total.
干预措施: Glyceryl Trinitrate (Drug)
Placebo
The formulation composition of the placebo will be the same as the active spray minus the Glyceryl Trinitrate.
干预措施: Placebo (Drug)
结局指标
主要结局
The emotionally salient version of the Jumping to Conclusions (JTC) task
时间窗: Change in performance from baseline to Day1, Day 2, Day 3, Day 7
次要结局
- The Hopkins Verbal Learning Task - Revised, immediate recall(Change from baseline to Day1, Day 2, Day 3, Day 7)
- Positive and negative syndrome scale (PANSS) (videotaped)(Change from baseline to Day1, Day 2, Day 3, Day 7)
- The Bond-Lader Visual Analog Scales(Change from baseline to Day1, Day 2, Day 3, Day 7)