治疗耐药抑郁症的成年人中的单一治疗:一项随机临床试验
Adam Janik1, Xin Qiu2, Rosanne Lane2
1Department of Neuroscience, Johnson & Johnson, San Diego, California.
JAMA psychiatry
|July 2, 2025
概括
在治疗耐药性抑郁症 (TRD) 的成年人中,Esketamine鼻喷剂单疗显著降低了抑郁症症状. 这项研究发现,对 TRD 患者而言,以斯基坦胺单一疗法是有效的选择,这些患者对口服抗抑郁药物没有反应.
科学领域:
- 精神病学和神经科学 精神病学和神经科学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 当与口服抗抑郁药一起使用时,Esketamine鼻喷剂已被批准用于治疗耐药抑郁症 (TRD).
- 作为TRD的单一疗法,埃斯基坦胺鼻喷剂的疗效尚未先前评估.
研究的目的:
- 评估与安慰剂相比,在TRD患者减轻抑郁症状方面,单独治疗esketamine的疗效和安全性.
- 为了评估埃斯基坦胺单疗在治疗耐药抑郁症中的有效性.
主要方法:
- 第4期,双盲,安慰剂对照随机临床试验,涉及378名患有严重抑郁症和对口服抗抑郁药不充分反应的成年人.
- 参与者在没有抗抑郁药的期间后,每周两次,每周接受固定剂量的鼻内乙胺 (56毫克或84毫克) 或安慰剂,持续4周.
- 主要疗效终点是蒙哥马利-阿斯伯格抑郁评分表 (MADRS) 评分从基线到28日的变化.
主要成果:
- 与安慰剂相比,在28日以埃斯凯特胺单一治疗显示,在56毫克 (-5.1分) 和84毫克 (-6.8分) 剂量中,MADRS评分在统计学上显著降低.
- 在第一个剂量后24小时,对于两种埃斯基坦胺剂量也观察到显著的改善.
- 常见的治疗出现的不良事件包括恶心,分离,头和头痛.
结论:
- 单独使用石胺疗法有效降低TRD成年患者的抑郁症状.
- 这一发现表明,胺单疗可能为TRD患者提供一种新的治疗选择,这些患者经历了耐受性问题或对口服抗抑郁药的不反应.
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