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艾斯凯特胺对患有严重抑郁症的青少年即将发生自杀风险的抑郁症状的影响:一项随机精神活性受控研究
Colette Kosik-Gonzalez1, Dong-Jing Fu1, Li Nancy Chen1
1Janssen Research & Development, LLC, a Johnson & Johnson company, Titusville, New Jersey.
概括
结合标准护理,Esketamine鼻喷剂显著减少了自杀青少年的抑郁症状. 这种快速治疗为即将面临危险的患有严重抑郁症的年轻人提供了希望.
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.
- 青少年医学 青少年医学
背景情况:
- 青少年患重度抑郁症 (MDD) 存在重大风险,包括自杀倾向.
- 快速减轻症状对于即将发生自杀风险的青少年至关重要.
- 现有的治疗方法可能对严重症状的发病速度有限制.
研究的目的:
- 在患有MDD和迫在眉的自杀风险的青少年中,与安慰剂相比,评估esketamine鼻喷剂的疗效和安全性.
- 为了评估在第一个剂量后24小时内埃斯基坦胺的快速抗抑郁作用.
- 为了确定这种脆弱人群中埃斯基坦胺的耐受性.
主要方法:
- 这是一项双盲,双假人,随机的2b期研究,涉及147名青少年 (12至<18岁).
- 参与者每周两次接受埃斯基他 (28,56或84毫克) 或米达佐拉姆安慰剂,持续4周,并接受标准护理.
- 主要终点是儿童抑郁症评分尺度修订 (CDRS-R) 评分从基线到剂后24小时的变化.
主要成果:
- 聚合剂量 (56和84毫克) 的乙胺在24小时后降低CDRS-R得分方面表现优于米达佐拉姆 (p = .037).
- 在所有组中都观察到自杀倾向严重程度的改善,尽管在乙胺和安慰剂之间没有统计学意义.
- 埃斯基他胺的常见不良事件包括头,恶心,解离和头痛.
结论:
- 该研究满足了其主要疗效终点,表明聚合式胺剂量 (56和84毫克) 迅速改善了抑郁症状.
- 作为综合标准护理的辅助剂,Esketamine为患有MDD和迫在眉的自杀风险的青少年提供了一个有前途的快速治疗选择.
- 进一步的研究可能会探索最佳剂量和长期影响,同时监测不良事件是必不可少的.
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