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用MM120 (lysergide) 治疗一般性焦虑症:随机临床试验
Reid Robison1, Robert Barrow2, Craig Conant2
1Cedar Clinical Research, Draper, Utah.
JAMA
|September 4, 2025
概括
单剂量MM120显著降低了中度至严重的泛性焦虑障碍 (GAD) 的成年人. 高剂量的MM120显示出剂量依赖的效果,支持其作为GAD治疗的潜力.
科学领域:
- 精神病学
- 药理学
- 临床试验
背景情况:
- 一般焦虑症是一种常见的精神疾病,需要有效的治疗.
- 目前用于治疗GAD的药物治疗需要持续研究以提高疗效和耐受性.
研究的目的:
- 调查MM120 (lysergide D- tartrate) 的剂量反应关系,对患有中度至重度GAD的成年人进行研究.
- 与安慰剂相比,评估单剂量MM120在不同剂量范围中的疗效.
主要方法:
- 一项2b期,多中心,随机,双盲,安慰剂对照的研究,涉及198名中度至重度GAD的成年人.
- 参与者接受了单剂量MM120 (25,50,100或200微克) 或安慰剂.
- 通过使用MCP- Mod方法分析的汉密尔顿焦虑评分表 (HAM- A) 4周后的变化来评估主要结果.
主要成果:
- 与安慰剂相比,对100微克和200微克的MM120剂量组在第4周观察到HAM- A得分的统计显著下降.
- 25微克和50微克的MM120剂量组与安慰剂没有统计学上显著的差异.
- 包括视觉感知变化,恶心和头痛在内的不良反应依赖于剂量,并且与已知的副作用一致.
结论:
- 在中度至重度的GAD患者中,单次使用MM120显示出剂量依赖的焦虑症状减轻.
- 这些发现支持MM120的疗效,并为未来的第三阶段试验选择最佳剂量提供关键数据.
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