艾斯美沙 (REL-1017) 在患有重度抑郁症和抗抑郁药高压症的患者中:从第三阶段随机对照试验的探索性后期分析
Clotilde Guidetti1,2,3, George I Papakostas1, Luca Pani4,5
1Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.
The Journal of clinical psychiatry
|October 8, 2025
概括
埃斯美沙在治疗患有抗抑郁药耐受性 (AT) 的重大抑郁障碍 (MDD) 患者方面表现有前途. 这项研究发现,尽管服用了足够的抗抑郁剂剂量,但在复发的患者中,埃斯美沙显著改善了症状.
科学领域:
- 精神病学是一个精神病学.
- 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:
- 抗抑郁药物耐受性 (AT) 的特点是最初的反应,然后在相同剂量下复发.
- 对未来抗抑郁药治疗疗效的AT的预后价值尚不清楚.
研究的目的:
- 评估埃斯美沙 (REL-1017) 在有AT史的大型抑郁症 (MDD) 患者的疗效.
- 为了确定埃斯美沙能否在这个特定的患者亚组中克服治疗耐药性.
主要方法:
- 一个第三期,双盲,随机,安慰剂对照试验,涉及成年MDD门诊患者.
- 抗抑郁药耐受性 (AT) 在随机化前使用MGH抗抑郁药治疗响应问卷进行评估.
- 在AT小组中,从基线到第28天的蒙哥马利-阿斯伯格抑郁评分表 (MADRS) 评分的变化来衡量有效性.
主要成果:
- 在227名患者中,有87人经历过AT. 在这个小组中,甲与安慰剂相比,MADRS得分在统计学上显著改善 (平均差异5.4,P=.023).
- 观察到响应率的统计学上显著差异 (P=.0004).
- 在每项方案和严重抑郁的AT小组中,观察到一致的积极结果.
结论:
- 后期分析表明,埃斯美沙可能是AT的MDD患者的有效辅助治疗.
- 需要在更大规模的前性临床试验中进一步证实这些发现的有效性.
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