Inhaled Nitrous Oxide for Acute Suicidality and Depression in the Emergency Department
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Treatment Response Based on Changes in Computerized Adaptive Testing Scores
研究概览
简要总结
Investigators are conducting this double-blind, randomized control trial (RCT), to compare inhaled N2O+ treatment as usual (TAU) versus inhaled placebo+TAU; demonstrating the feasibility and tolerability of the intervention in an emergency department (ED) setting on an acutely suicidal population.
详细描述
Past studies have shown that a single dose of ketamine, an NMDA- receptor antagonist has fast and long lasting anti-depressant effect. Although a promising antidepressant and potential anti-suicidal agent, ketamine has very significant side effects including: dissociation, hallucinations, delusional thinking, cognitive impairment, and significant sympathetic nervous system activation.
Nitrous Oxide (N2O) is an NMDA-receptor antagonist with a well-known safety profile used as an analgesic. In a proof-of-concept pilot study, this study's investigator recently demonstrated that N2O also has rapid and marked antidepressant effects in patients with severe treatment-resistant depression (TRD); further sub-analyses showed N2O significantly reduced suicidal ideation (SI). While N2O administration may lead to a reduction in SI, it remains unknown whether severely suicidal patients requiring hospitalization on inpatient psychiatric units would benefit. Investigators hypothesize that N2O will rapidly and safely dampen suicidal thinking with minimal side effects in this population.
Participants will be randomized to receive either N2O or placebo. The study intervention is in tandem with prescribed treatment-as-usual (TAU) by emergency department physicians relating to diagnosis (depression, anxiety, suicidal ideation); which typically involves anxiolytic medications and/or brief psychotherapy administered by care team psychiatry providers.
Study intervention response will be assessed using a self-administered psychiatric diagnostic tool (Computerized Adaptive Testing Mental Health [CAT-MH] scores relating to suicide, depression, and anxiety; to determine whether a single 45-minute inhalation of nitrous oxide vs placebo reduces 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, 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
- •Patients 18-65 years of age, acutely suicidal, presenting to the adult emergency department with documented history of non-psychotic major depressive disorder.
排除标准
- •Current psychotic or catatonic symptoms as determined by the hospital care team.
- •Unable or unwilling to give consent for study participation (ability to provide consent will be established by treating physician)
- •Lifetime DSM-V (medical history) diagnoses of schizophrenia, schizoaffective disorders, bipolar disorder, obsessive-compulsive disorder, and panic disorders.
- •Meets current DSM-V substance use disorder of greater than mild severity (other than nicotine or marijuana)
- •Significant pulmonary disease and/or requiring supplemental oxygen.
- •Administration of other NMDA-receptor antagonist treatment (e.g., ketamine) within two weeks of entry into study.
- •Contraindications for N2O (pneumothorax, bowel obstruction, middle ear occlusion, elevated intracranial pressure)
- •Chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B
- •Women who are pregnant or breastfeeding
- •Any other factor that in the investigators' judgment may affect patient safety or compliance.
研究组 & 干预措施
Treatment; Nitrous Oxide 50%
A single 45-minute session of inhaled 50% nitrous oxide.
干预措施: Nitrous oxide gas for inhalation (Drug)
Control; Oxygen-air mixture
A single 45-minute session of inhaled Oxygen-air mixture
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment Response Based on Changes in Computerized Adaptive Testing Scores
时间窗: Up to 24-hours from baseline
Monitor changes in Computerized Adaptive Testing Mental Health (CAT-MH) scores relating to suicide, depression, and anxiety; to determine whether a single 45-minute inhalation of nitrous oxide vs placebo reduces symptoms. The CAT-MH is a validated self-reporting electronic diagnostic that adaptively selects a small optimal set of items from a large bank of approximately 1,500 items, targeted to individuals current or historical level of severity and likelihood of 'suicide', 'depression', and 'anxiety'. Generated scores include severity and liklihood percentile: * suicide = (%) low, intermediate, high * depression = (%) normal, mild, moderate, severe * anxiety = (%) normal, mild, moderate, severe
次要结局
- Rapid Treatment Response(At 30-minutes to 1-hour from intervention conclusion)
- Sustained Treatment Response(Up to 24-hours from intervention conclusion)
- Treatment Compliance(Intervention completion, 45-minutes)
- Treatment Response Correlation to Lifetime Predictors Associated with Suicide(Up to 24-hours from baseline)