进步:第三阶段,随机,双盲,安慰剂对照研究,辅助皮马万塞林治疗精神分裂症的患者对抗精神病治疗反应不足
Dragana Bugarski-Kirola1, Istvan Bitter2, I-Yuan Liu3
1Clinical Research, Acadia Pharmaceuticals GmbH, Basel, Switzerland.
Schizophrenia bulletin open
|August 15, 2024
概括
皮马万塞林没有达到治疗精神分裂症症状的首要目标. 然而,这种5-HT2A受体逆agonist显示出改善不充分抗精神病反应的患者负面症状的趋势.
科学领域:
- 精神病学和行为科学
- 神经科学是一个神经科学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 对抗精神病药物的不充分反应是精神分裂症管理的一个重大挑战.
- 在这个患者群体中,研究了5-HT2A受体逆agonist/antagonist,pimavanserin,用于辅助治疗.
研究的目的:
- 评估pimavanserin作为精神分裂症成人门诊患者的附加治疗的疗效和安全性,这些患者对目前的抗精神病治疗反应不足.
主要方法:
- 一项为期6周的随机,双盲,安慰剂控制的研究,在北美和欧洲进行.
- 患有精神分裂症的成人门诊患者 (PANSS评分65110,在抗精神病药物下稳定8周) 除了正在服用的抗精神病药物外,还接受了皮马万塞林20毫克/天或安慰剂.
- 在前3周允许灵活剂量使用皮马万塞林;主要终点是从基线到第6周的PANSS总得分的变化.
主要成果:
- 主要疗效终点 (PANSS总分数的变化) 在统计上没有达到 (LS平均差异: -2.1,P = .094),尽管观察到有利于皮马万塞林的趋势.
- 探索性分析显示,在第6周的PANSS消极症状分量和马德尔消极症状因子得分上,皮马万塞林与安慰剂的统计学上显著的分离.
- 对欧洲地区的亚组分析表明,对于PANSS总得分和临床全球印象-严重性得分,有显著的差异有利于pimavanserin.
结论:
- 虽然没有达到主要终点,但皮马万塞林在精神分裂症患者和不充分的抗精神病反应中显示出改善负面症状的趋势.
- 观察到的负面症状改善的趋势表明,皮马万塞林可能需要对这一适应症进行进一步的研究.
- 在pimavanserin和安慰剂组之间,不良事件是可比的.
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