NCT04957368已完成4 期
Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Withdrawal rate
研究概览
简要总结
The purpose of the study is to investigate a short-term treatment option for major depressive disorders by administering nitrous oxide gas. At this time, the main purpose is to complete a feasibility study with 40 participants suffering from treatment-resistant depression. Participants will be randomized to (1) Study group: Nitrous oxide (inhaled) + solution of saline (injected) and the (2) Control group: Oxygen (inhaled) + Midazolam (injected) as an Active Placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, 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
- •18 to 65 years of age
- •Meeting Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for Major Depressive Disorder (MDD)
- •Current major depressive episode as confirmed by the Mini International Neuropsychiatric Interview (MINI) for DSM-5
- •Experiencing moderate to severe depressive episode, as defined by the Hamilton Depression Rating Scale (HAMD)>17
- •Failure of two trials of antidepressant therapy of adequate dose and duration, during the current depressive episode
- •For women of childbearing potential, use of highly effective or double-barrier methods of contraception. Abstinence is acceptable if it is the preferred and usual lifestyle of the female participant
- •Capacity to provide informed consent.
- •Exclusion criteria
- •Acute suicidality defined as score ≥3 on HAMD item 3
- •Major Depressive Episode in people with Bipolar Disorder
- •Current substance abuse or dependence and/or history of alcohol abuse or dependence within the past year
- •Current or lifetime history of schizophrenia or schizoaffective disorder
- •Current history of dissociative disorders
- •Known history of hypersensitivity or allergy to Nitrous Oxide, Midazolam or any ingredients in the study formulations
- •Contraindication to receiving nitrous oxide
- •Chronic cobalamin or folate deficiency
- •Contraindication to receiving the placebo midazolam
- •Use of centrally acting medicinal products, such as opioid agonists, morphine derivatives, benzodiazepines and/or other central nervous system depressants such as barbiturates and alcohol
- •Pregnancy or breastfeeding in female participants
- •Electroconvulsive therapy within the current depressive episode
- •Receiving ketamine treatment within the current depressive episode
- •Unwilling to maintain current antidepressant regimen.
排除标准
- 未提供
研究组 & 干预措施
Nitrous Oxide + saline solution
Experimental
干预措施: Nitrous Oxide 99 % (Drug)
Oxygen + Midazolam
Active Comparator
干预措施: Oxygen + Midazolam (Drug)
结局指标
主要结局
Withdrawal rate
时间窗: 2 Years
Recruitment rate
时间窗: 2 Years
Recruitment rate
Adherence rate
时间窗: 2 Years
Feasibility
Frequency of adverse events
时间窗: 2 Years
Safety and tolerability
次要结局
- Montgomery-Åsberg Depression Rating Scale (MADRAS) Score 0-60 (Higher scores represent higher depression). Measure changes in symptoms of depression(6 weeks)
- Toronto Side Effects Scale (TSES) - 32 items (each item has a score 1-25; higher score means higher intensity). Measure adverse side effects from antidepressant treatment(6 weeks)
研究者
研究点 (1)
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