艾克莱珀丁 (BI 425809) 与精神分裂症患者辅助计算机认知训练的有效性和安全性
Philip D Harvey1, Sean McDonald2, Eric Fu3
1University of Miami Miller School of Medicine, 1120 NW 14th Street, 33136, Miami, FL 33136, USA.
Schizophrenia research. Cognition
|January 6, 2025
概括
这项研究研究了结合精神分裂症认知障碍的认知训练的iclepertin,没有发现显著的疗效改善,但一致的安全性. 需要进一步的研究才能找到有效的治疗方法.
科学领域:
- 神经科学是一个神经科学.
- 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.
背景情况:
- 与精神分裂症相关的认知障碍 (CIAS) 显著影响患者负担.
- 目前没有批准用于治疗CIAS的药物疗法.
- 计算机化认知训练 (CCT) 是有前途的,但需要增强.
研究的目的:
- 评估iclepertin作为CIAS家庭CCT的辅助剂的疗效和安全性.
- 评估伊克莱珀丁对神经认知,功能能力和精神症状的影响.
主要方法:
- 第二阶段,双盲,安慰剂控制,并行组试验.
- 200名患有精神分裂症的参与者每天接受10毫克或安慰剂的伊克莱珀丁,持续12周,同时接受CCT.
- 主要终点:神经认知复合T分数 (MATRICS共识认知电池) 的变化.
主要成果:
- 在第12周,在iclepertin和安慰剂组之间,认知,功能或精神病的结果没有显著差异.
- 伊克莱珀丁10毫克+CCT组报告了39个不良事件;安慰剂+CCT组报告了57个.
- 副作用一般为轻度至中度,没有发现新的安全风险.
结论:
- 在与CCT结合使用时,Iclepertin 10 mg并没有在改善CIAS方面显示出有效性.
- 伊克莱珀丁10毫克的安全性概况与之前的研究一致.
- 这项试验是迄今为止对CIAS进行的最大的组合治疗研究.
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