The Effect of Nitrous Oxide on EEG, a Randomized, Double-blinded Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Slow wave activity
研究概览
简要总结
Our recent preclinical observations suggest that monitoring of slow electroencephalogram (EEG) oscillations may be used to predict the efficacy of rapid-acting antidepressants such as ketamine or nitrous oxide. In this project we will carry out critical clinical research on healthy volunteers and study the effects of nitrous oxide on EEG. Results will be used for the design of clinical trials on depressed individuals. The project will be done in collaboration between neuroscientists at the University of Helsinki and clinicians at the Tampere University Hospital.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •informed consent obtained
- •age between 18 - 40
- •body mass index 18 - 27
排除标准
- •Age < 18 or > 40
- •Alcohol Use Disorders Identification Test (AUDIT) >6 points
- •Drug Abuse Screening Test 20 (DAST-20) > 0 points
- •Beck Depression Inventory (BDI) > 11 points
- •Symptom Check List 90 (SCL-90) over mean values of Finnish population in any dimensions of the SCL-90 or the global severity index
- •Any respiratory disorder including sleep apnea
- •Any heart illness
- •Known vitamin B12 deficiency
研究组 & 干预措施
Intermittent nitrous oxide
10 minutes of 50% nitrous oxide + 10 min 100% oxygen + 10 min 50% nitrous oxide + 10 min 100% oxygen
干预措施: Nitrous Oxide (Drug)
Continuous nitrous oxide
20 min 50% nitrous oxide + 20 min 100% oxygen
干预措施: Nitrous Oxide (Drug)
结局指标
主要结局
Slow wave activity
时间窗: Following 20 minutes after nitrous oxide administration
Delta wave in EEG
次要结局
- Self-reported psychiatric symptoms(Baseline, 20 minutes after nitrous oxide)
- Side effects - mood elevation(Baseline, 20 minutes after nitrous oxide)
- Side effects - nausea(Baseline, 20 minutes after nitrous oxide)
- Side effects - agitation(Baseline, 20 minutes after nitrous oxide)
- Side effects - restlessness(Baseline, 20 minutes after nitrous oxide)
- Side effects - tension(Baseline, 20 minutes after nitrous oxide)
- Side effects - anxiety(Baseline, 20 minutes after nitrous oxide)
- Side effects - uneasiness(Baseline, 20 minutes after nitrous oxide)
- Side effects - tiredness(Baseline, 20 minutes after nitrous oxide)
- Side effects - numbness(Baseline, 20 minutes after nitrous oxide)
- Side effects - dizziness(Baseline, 20 minutes after nitrous oxide)