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关于简化批准用于治疗精神分裂症的认知增强剂的途径的考虑
Keith H Nuechterlein1,2, Michael F Green1,3, Stephen R Marder1,3
1Department of Psychiatry and Biobehavioral Sciences, Jane and Terry Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, CA 90095-6968, United States.
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概括
开发用于精神分裂症的认知增强剂是具有挑战性的. 测量和治疗研究以改善精神分裂症的认知 (MATRICS) 计划为试验设计和测量提供了有价值的见解,解决了药物开发的实际挑战.
科学领域:
- 精神病学和神经科学 精神病学和神经科学
- 临床试验设计 临床试验设计
- 认知增强疗法 认知增强疗法
背景情况:
- 精神分裂症治疗在开发和验证认知增强剂方面面临重大障碍.
- 旨在改善精神分裂症认知的测量和治疗研究 (MATRICS) 过程旨在标准化测量和试验设计.
- 以前的努力集中在辅助性认知增强剂上,需要对新型单一疗法的修订策略.
研究的目的:
- 为MATRICS计划的测量程序和临床试验设计建议提供专家观点.
- 讨论关于使用 MATRICS 共识认知电池 (MCCB) 的实际挑战和潜在夸大.
- 探索对评估具有抗精神病和增强认知功能的新型单一疗法的临床试验设计所需的修订.
主要方法:
- 对MATRICS过程的审查,涉及学术界,工业界,NIMH和FDA代表.
- 对 MATRICS 共识认知电池 (MCCB) 的实际应用和感知挑战的分析.
- 讨论临床试验的功能性共同初级措施的复杂性.
- 考虑修订的试验设计,以评估单一治疗与辅助治疗.
主要成果:
- 承认MCCB实施的实际挑战,同时指出一些问题被夸大了.
- 如果II期试验显示没有负面的认知影响,建议为III期试验提供简要的MCCB.
- 突出了功能性共同初级结果措施的复杂性和考虑因素.
- 同意需要修订最初的 MATRICS 建议,以评估单一疗法.
结论:
- MATRICS倡议为推进精神分裂症认知增强研究提供了一个关键的框架.
- 战略性的使用MCCB,可能是简短的格式,可以促进高效的临床试验.
- 调整试验设计对于准确评估针对精神病和认知的新型单一疗法至关重要.
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