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随着笑气暴露而持续改善情绪 (SMILE):对治疗耐药抑郁症的氧化随机控制的试点试验的研究方案

Karim S Ladha^1,2, Jiwon Lee^2,3, Gabriella F Mattina²

¹Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada.

|January 19, 2024

概括

这项试点研究调查了重复使用氧化治疗治疗耐药抑郁症的可行性和初步疗效. 结果将为未来对这种潜在的快速作用干预措施的试验提供信息.

科学领域:

精神病学是一个精神病学.
神经科学是一个神经科学.
药理学药理学是指药理学的学科.

背景情况:

耐治疗抑郁症 (TRD) 需要新的干预措施.
氧化显示出TRD的潜力,但对重复使用的证据有限.
需要在活性氧化的安慰剂对照试验中进行最佳的失明.

研究的目的:

为了检查TRD患者每周服用氧化4周疗程的可行性.
评估氧化与活性安慰剂 (midazolam) 相比的初步疗效.
为未来的TRD中氧化的最终试验的设计提供信息.

主要方法:

随机的,活跃的安慰剂控制的试验试验.
40名TRD参与者每周吸入氧化或氧气,持续4周.
通过招募,退出,坚持和不良事件评估可行性;根据MADRS分数评估有效性.

主要成果:

评估了主要可行性结果 (招聘,坚持,不良事件).
探索性结果包括蒙哥马利-阿斯伯格抑郁评分表 (MADRS) 评分的变化.
研究结束时评估了缓解和反应率.

结论:

该研究提供了TRD中重复氧化的可行性和初步疗效数据.
结果将指导更大,更确定的试验的设计.
氧化可能是TRD的可行,快速起作用的治疗方法.

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