克萨诺梅林-化在精神分裂症中的有效性和安全性:一项随机临床试验
Inder Kaul1, Sharon Sawchak1, David P Walling2
1Karuna Therapeutics, Boston, Massachusetts.
JAMA psychiatry
|May 1, 2024
概括
在精神分裂症患者中,xanomeline-trospium显著减少了精神病症状. 这种没有D2受体活性的新型抗精神病药在第三期试验中显示出有效性和良好的耐受性.
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:
- 需要新的抗精神病药物,以提高疗效和耐受性.
- 赞诺梅林是一种肌肉蛋白受体激动剂,KarXT将其与化结合,以减轻外围副作用.
- 之前的研究表明,xanomeline-trospium在精神分裂症中具有有效性和耐受性.
研究的目的:
- 在成年精神分裂症患者中,与安慰剂相比,评估xanomeline-trospium的疗效和安全性.
- 评估沙诺梅林-托对精神病症状和不良事件的影响.
主要方法:
- 第三阶段,随机,双盲,安慰剂对照试验 (EMERGENT-3) 涉及256名患有精神分裂症的成年人经历急性精神病.
- 参与者接受了xanomeline-trospium (最大剂量为125 mg/30 mg) 或安慰剂5周.
- 主要终点:从基线到第5周的阳性和阴性综合征量表 (PANSS) 总得分的变化.
主要成果:
- 与安慰剂相比,xanomeline-trospium显著降低了PANSS总得分 (平均差异为-8.4,P<.001).
- 由于不良事件导致的停药率在两组之间是相似的 (6.4%对5.5%).
- 随着xanomeline-trospium的常见不良事件包括恶心,消化不良和吐;额外的pyramidal症状和体重增加与安慰剂相似.
结论:
- 赞诺梅林-托斯皮乌姆证明了有效性,并且在患有严重精神分裂症急性精神病发作的患者中耐受良好.
- 这些发现支持xanomeline-trospium作为一种潜在的第一类抗精神病药物,缺乏直接D2多巴胺受体阻塞.
- 这些结果与之前的EMERGENT试验数据一致,增强了这种新疗法方法的潜力.
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