NCT05008939Unknown不适用
Subanesthetic Sevoflurane for Treatment-Resistant Depression: A Proof-of-Concept Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17)
研究概览
简要总结
This study intends to carry out a prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subanesthetic sevoflurane for treatment-resistant depression.
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
- •age 18-65 years
- •meeting DSM-V criteria for major depressive disorder
- •a pretreatment score ≥17 on HDRS-17
- •meeting criteria for TRD, defined as having had at least two adequate dose-duration antidepressant medication failures in the current depressive episode.
- •current treatment drugs were stably used for at least 4 weeks
排除标准
- •MDD with psychosis, e.g., bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, et al
- •Drug, tobacco or alcohol abuse
- •active suicidal intention
- •previous administration of NMDA receptor antagonists (e.g., ketamine)
- •previous (<6 weeks prior) or ongoing treatment with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
- •pregnancy or breastfeeding
- •morbidly obese, BMI>35kg/m2
- •other diseases that could interfere with the results
研究组 & 干预措施
sevoflurane
Experimental
Those with 1-hour inhalation of 1% sevoflurane/30% oxygen
干预措施: Sevoflurane (Drug)
sevoflurane
Experimental
Those with 1-hour inhalation of 1% sevoflurane/30% oxygen
干预措施: Placebo (Drug)
placebo
Placebo Comparator
Those with 1-hour inhalation of 30% oxygen
干预措施: Placebo (Drug)
结局指标
主要结局
Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17)
时间窗: 24 hours after the end of treatment
≥50% HDRS-17 reduction in depressive symptoms
次要结局
- Rates of remissions in HDRS-17(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
- Rates of remissions in MADRS(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
- The assessment of anxiety with self-rating scale(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
- The assessment of improvement with self-rating scale(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
- Rates of treatment responses in HDRS-17(2 hours, 7 days,14 days and 28 days after the end of treatment)
- The assessment of depression with self-rating scale(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
- The assessment of improvement by psychiatrist(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
- The assessment of side effects with self-rating scale(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
- Rates of treatment responses in Montgomery-Åsberg Depression Rating Scale (MADRS)(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
- The assessment of anxiety by psychiatrist(2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment)
- Side effects of sevoflurane(up to 2 hours after the end of treatment)
研究者
研究点 (1)
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