治疗耐药性抑郁症时使用石胺的安全性和有效性:长期扩展研究
Naim Zaki1, Li Nancy Chen2, Rosanne Lane2
1Department of Neuroscience, Janssen Research & Development, LLC, a Johnson & Johnson company, Titusville, NJ, USA.
概括
治疗耐药性抑郁症 (TRD) 患者在长期使用斯凯胺鼻雾剂时,症状持续改善. 没有出现新的安全问题,这表明它有潜力管理难以治疗的大型抑郁症.
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:
- 与严重抑郁症相比,耐治疗抑郁症 (TRD) 与复发和自杀风险更高有关.
- 显著的大多数 (70%) 起初对治疗有反应的TRD患者在六个月内复发.
研究的目的:
- 评估ESKETAMINE鼻喷雾剂的长期安全性和有效性,当与诊断为TRD的患者的口服抗抑郁药一起使用时.
- 评估抗抑郁药效应的持久性,并确定长期治疗期间出现的任何安全信号.
主要方法:
- 从2016年6月到2022年12月进行了第三阶段,开放标签,单臂长期延伸研究 (SUSTAIN-3).
- 招募了1148名患有TRD的成年患者,在监督下接受灵活的鼻内雌激素剂量.
- 通过使用蒙哥马利-阿斯伯格抑郁评分表 (MADRS) 测量抑郁症状的变化来衡量有效性.
主要成果:
- 埃斯基坦胺的总暴露是3777个累积的患者年,在SUSTAIN-3中平均持续时间为42.9个月.
- 常见的不良事件包括头痛,头和恶心;5.3%和6.4%的患者因缺乏疗效或不良事件而停止治疗.
- 平均MADRS得分在诱导期间下降,在维持期间保持稳定,在终点时缓解率达到49.6%.
结论:
- 在TRD患者中,长期使用间歇剂量埃斯基坦胺鼻雾剂的治疗没有显示出新的安全信号.
- 在继续维持治疗的患者中观察到抑郁症状的持续改善.
- 这些发现有助于证据基础为胺在治疗耐药性抑郁症的管理中的作用.
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