A Clinical Trial of Nitrous Oxide for Treatment-Resistant Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale-17 item (HDRS-17)
研究概览
简要总结
This study aims at investigating the persistence of antidepressant effect of Nitrous Oxide (N2O) for Treatment-Resistant Depression(TRD). The investigators also aim to assess the effect of N2O on the electroencephalograph, multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in patients with TRD. The investigators further aim to identify the predictors of N2O's antidepressant effeect using the above techniques.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years, both sexes), with ICD-10 criteria for MDD without psychosis, as determined by a structured clinical interview Mini International Neuropsychiatric Interview
- •Moderate to severe depression, as defined by a pretreatment score >17 on the HDRS-17 scale
- •TRD was defined as having had at least two adequate dose-duration, antidepressant medication failures in the current episode and a lifetime failure of at least three antidepressant medication trials.
- •Informed consent to participate in this study
排除标准
- •A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview
- •Active or recent (<12 months) substance abuse or dependence; excluding nicotine
- •Presence of acute medical illness that could interfere with study participation, including significant pulmonary disease
- •Acute severe suicidal ideation
- •Acute psychosis
- •Received ECT treatment within 6 months
- •History of NMDA-antagonists (e.g., ketamine) intake
- •Pregnancy or breastfeeding
- •Any contraindications to the use of nitrous oxide (e.g., pneumothorax, middle ear occlusion, elevated intracranial pressure, chronic cobalamin or folate deficiency unless treated with folic acid or vitamin B12).
研究组 & 干预措施
Air oxygen mixture
participants in this arm inhale mixed oxygen-air gas (inspired oxygen concentration ~50%).
干预措施: Placebo (Drug)
Nitrous oxide
Participants in this group inhale mixed 50% nitrous oxide and 50% oxygen.
干预措施: Nitrous Oxide (Drug)
结局指标
主要结局
Change in Hamilton Depression Rating Scale-17 item (HDRS-17)
时间窗: Baseline, 2hours, 24hours, 7days, 2weeks
Interview-based questionnaire used to measure the severity of depression. Consists of 17 items with a score calculated. Higher scores are associated with more severe depression. 0 - 7 = Normal; 8 - 17 = Mild Depression; 18 - 24 = Moderate Depression; \> 25 = Severe Depression; Maximum score = 52
Change in QIDS-16-SR (Quick Inventory of Depressive Symptomatology-16 Self Report)
时间窗: Baseline, 2hours, 24hours, 7days, 2weeks
This is a 16-item self report questionnaire that measures depressive symptoms. Improvement is reported in change in depressive score score ranges from 0-27, with higher numbers indicating more severe symptom reporting. Change is calculated by baseline plus/minus the value at the later time point
Change in Visual Analog Scale-Depression (VAS-D)
时间窗: Baseline, 2hours, 24hours, 7days, 2weeks
All patients are asked to fill out visual analog scale for depression (VAS-D) before and after the intervention. VAS-D is a self-report scale for ddepression severity, with 0 score indicating not at all depressed and 10 score indicating extremely depressed.
次要结局
- Chang in Event Related Potentials (ERPs)(Baseline, 24hours, 7days, 2weeks)
- Change in voxel-based morphometry of grey matter, white matter as assessed by structural magnetic resonancce imaging.(Baseline, 24hours)
- Change in Functional connectivity(Baseline, 24hours)
- Change in peripheral blood cytokines(Baseline, 2hours, 24hours)
- Change in feces bacterial flora(Baseline)
- Change in the TMT/A and B (Executive Function)(Baseline, 24hours, 7days, 2weeks)
- Change in Congruent STROOP Time to Complete (Executive Function)(Baseline, 24hours, 7days, 2weeks)
- Digit-Span Test(Baseline, 24hours, 7days, 2weeks)
- Change in DSST (Number of Correct Symbols)(Baseline, 24hours, 7days, 2weeks)
- Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)(Baseline, 2hours, 24hours, 7days, 2weeks)
- Change in Hamilton Anxiety Rating Scale (HAM-A)(Baseline, 2hours, 24hours, 7days, 2weeks)
研究者
Lingjiang Li
President of Chinese Psychiatry Society of Chinese Medical Association
Central South University