Nitrous Oxide as Treatment for Major Depression - a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale HDRS-21
研究概览
简要总结
Major depressive disorder (MDD) is a global medical problem with significant shortcomings in current therapy. Chief among these is the delay between initiation of pharmacologic therapy and clinical improvement in symptoms. Recently ketamine, an NDMA-receptor antagonist has been shown to rapidly and effectively reverse the symptoms of MDD. Nitrous oxide, another NMDA-receptor antagonist, may produce the same effect with a cleaner side-effect profile and perhaps without the need for intravenous access and anesthesia personnel. Therefore, we propose conducting a pilot randomized placebo controlled double-blind crossover study in which patients will receive up to 50% nitrous oxide in oxygen or up to 50% oxygen in air for a period of one hour in addition to standard medical therapy. Depression severity will be assessed by a blinded observer pre-treatment, 30 minutes and 2 hours post treatment using the Hamilton depression rating scale.
详细描述
We will study 20 patients with non-treatment resistant major depression and 20 patients with treatment-resistant major depression, defined as failure of at least 2 antidepressants in the current depressive episode and 3 lifetime medication failures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Adults 18-65 years of age
- •Major depressive disorder without psychosis with as determined by structured interview using the Mini-International Neuropsychiatric Interview (MINI).
- •(baseline )
- •HDRS-21 score of >18
- •Good command of the English language
排除标准
- •History of:
- •Bipolar disorder
- •Schizoprenia
- •Schizoaffective disorder
- •Obsessive-compulsive disorder, panic disorder
- •Substance abuse or dependence (except for remote substance abuse or dependence with remission at least 1 year prior to the study and except for nicotine use disorders)
- •Axis II diagnoses that may interfere with the patient's ability to improve on nitrous oxide
- •Acute medical illness that may pose subject at risk during nitrous oxide administration
- •Active suicidal intention (inability to contract for safety)
- •Active psychotic symptoms
- •Patients with significant pulmonary disease and/or requiring supplemental oxygen
- •Contraindication against the use of nitrous oxide:
- •Pneumothorax
- •Bowel obstruction
- •Middle ear occlusion
- •Elevated intracranial pressure
- •Chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B12
- •Pregnant patients
- •Breastfeeding women
- •Previous administration of NMDA-receptor antagonists (e.g., ketamine) within the last 3 months
- •Current electro-convulsive therapy treatment
- •Any active suicidal ideation, intention, or planning (clinical assessment of suicidality will be used)
研究组 & 干预措施
N2O/Placebo
First session: Nitrous oxide Second session: placebo
干预措施: Nitrous Oxide (Drug)
N2O/Placebo
First session: Nitrous oxide Second session: placebo
干预措施: Placebo (Drug)
Placebo/N2O
First session: Placebo Second session: Nitrous Oxide
干预措施: Nitrous Oxide (Drug)
Placebo/N2O
First session: Placebo Second session: Nitrous Oxide
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Hamilton Depression Rating Scale HDRS-21
时间窗: baseline and 24 hours
(21-point Hamilton Depression Rating Scale) Scoring is based on the first 17 items on the 21 point scale. Eight items are scored on a 5-point scale, ranging form 0=not present to 4= severe. Nine are scored from 0-2.
次要结局
- Change in Quick Inventory of Depressive Symptomatology - Self Report - QIDS -SR(baseline and 24 hours)