Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide - PROTORISC Pilote
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- suicidal ideation severity
研究概览
简要总结
Suicide prevention is a major public health concern, with nearly 9,000 suicides and over 200,000 suicide attempts reported each year in France. Suicide attempts and suicidal ideation are among the most frequent reasons for emergency room visits and psychiatric hospitalizations. Although there is no approved pharmacological treatment for suicidal crises, some psychiatric treatments appear promising. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has shown promising results in reducing suicidal ideation. However, its use is limited due to its side effects. Nitrous oxide, another NMDA receptor inhibitor commonly used in anesthesia and pain management, has demonstrated rapid antidepressant effects and few side effects. Given its rapid and lasting effects, nitrous oxide could swiftly alleviate suicidal ideation.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active suicidal ideations
- •Beck Scale for Suicidal Ideation score greater than or equal to 8
- •French speaking
- •Patient admitted to psychiatric emergency department
- •Capable of wearing a facial mask
- •Having signed an informed consent
- •Affiliated with social security
排除标准
- •Psychotic disorder, neurodegenerative disease, known substance use disorder (excluding caffeine or tobacco), substance intoxication, unstable somatic pathology
- •Pregnancy or breastfeeding
- •Contraindication to the use of nitrous oxide
- •Legal incapacity
- •Participation in another drug clinical trial
- •Patient subject to compulsory care measures
研究组 & 干预措施
Medical air administration
干预措施: Medical air (Drug)
Nitrous oxide administration
干预措施: Nitrous oxide (Drug)
结局指标
主要结局
suicidal ideation severity
时间窗: At Hour 4
Suicidal ideation severity decrease (SSI)
次要结局
- Suicidal ideation assessed by the SSI scale.(At Hour 24, at Hour 48, at Day 7 and at Month 1)
- Suicidal ideation assessed by the Columbia Suicidal Risk Severity Scale (C-SSRS).(At Day 0 and Day 7)
- suicidal ideation severity(At Hour 24, at Hour 48, at Day 7 and at Month 1)
- Depressive symptoms measured by hetero-assessment using the "Montgomery-Asberg Depression Rating Scale" (MADRS).(At Day 0 and Day 7)
- Depressive symptoms measured by the "Patient Health Questionnaire" PHQ-9 self-administered questionnaire.(At Day 0, At Hour 4, at Hour 24, at Hour 48 and at Day 7)
- Overall improvement measured by change in Clinical Global Impression - Improvement (CGI) scale score.(At Day 0 up to Hour 4, at Hour 24, at Hour 48 and at Day 7)
- Consumption of psychotropic medication for anxiolytic or sedative purposes.(At Hour 0 up to Hour 4)
- Intensity of anxiety measured by the "State and Trait Anxiety Inventory" (STAI) scale.(At Day 0 up to Hour 4, at Hour 24, at Hour 48 and at Day 7)
- Commitment to suicidal action in the month following inclusion(in the month following Day 0)