Nitrous Oxide in the Treatment of Acute Suicidal Ideation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Beck Scale for Suicidal Ideation (BSS)
研究概览
简要总结
The primary aim of the NITOS study is to investigate the potential rapid antisuicidal effects of N2O in the transdiagnostic treatment of suicidal ideation. On day 1, patients will receive either nitrous oxide (50% N2O balanced with oxygen) or placebo (50% oxygen balanced with air). Seven days after the first inhalation, a second inhalation will be performed. All patients will receive N2O at least once during this trial. While the first inhalation will be double-blind, only the patients but not the raters will be blinded to the second inhalation (day 8). For mechanism of action and prediction, a nested biomarker substudy will employ multimodal techniques including analysis of hair and blood samples, and EEG.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
50% nitrous oxide (N2O) plus 50% oxygen
Patients will be treated with N20 (50% N2O combined with 50% oxygen) for 45 minutes. Both the study subject and the rater will be blinded to the treatment assignment.
干预措施: 50% N2O plus 50% O2 (Drug)
50% oxygen plus 50% air
Here, patients will be treated with 50% oxygen plus air for 45 minutes. Both the study subject and the rater will be blinded to the treatment assignment.
干预措施: Oxygen (O2) (Drug)
结局指标
主要结局
Beck Scale for Suicidal Ideation (BSS)
时间窗: Day 0 to Day 2
Change of BSS score between Day 0 and Day 2. Double-blind treatment with either N2O or placebo inhalation on Day 1.
次要结局
- Montgomery-Åsberg Depression Rating Scale (MADRS )(Day 0 to Day 2)
- EEG changes associated with N2O / placebo inhalation(Day 1)
- Suicide Visual Analog Scale (S-VAS)(Day 1)
- Perceived Burdensomeness Visual Analog Scale (PB-VAS)(Day 1)
研究者
Sebastian Olbrich
Prof. Dr. med.
University of Zurich