Design of the National Adaptive Trial for PTSD-related Insomnia (NAP Study), VA Cooperative Study Program (CSP) #2016.
Design of the National Adaptive Trial for PTSD-related Insomnia (NAP Study), VA Cooperative Study Program (CSP) #2016.
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国家 PTSD 相关失眠适应性试验（NAP 研究）的设计，VA 合作研究计划 (CSP)
DOI：
10.1016/j.cct.2021.106540
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发表时间：
2021
影响因子：
2.2
通讯作者：
Shih,Mei
中科院分区：
文献类型：
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作者：
Krystal,JohnH;Chow,Bruce;Vessicchio,Jennifer;Henrie,AdamM;Neylan,ThomasC;Krystal,AndrewD;Marx,BrianP;Xu,Ke;Jindal,RipuD;Davis,LoriL;Schnurr,PaulaP;Stein,MurrayB;Thase,MichaelE;Ventura,Beverly;Huang,GrantD;Shih,Mei
目前还没有有效的药物治疗创伤后应激障碍（PTSD）相关的失眠。国家适应性试验的目的是有效地比较安慰剂与三种具有不同作用机制的失眠药物的效果，这些药物已经在美国退伍军人事务部（VA）医疗中心被广泛用于诊断为PTSD的退伍军人。本研究计划从34个VA医疗中心招募1224例患者，进行为期12周的前瞻性随机安慰剂对照临床试验，比较曲唑酮、右佐匹克隆和加巴喷丁。主要的结局指标是失眠，用失眠严重程度指数进行评估。这项研究的一个新的方面是它的自适应设计。在招募中点时，将进行中期分析，以告知关闭任何“无效”组（即，进一步招募不太可能产生显著结果的组）招募的决定，同时保持总体研究招募目标。这一步骤可能导致剩余研究组的富集，增强与安慰剂进行剩余比较的统计功效。本研究还将探索治疗反应的临床、活动记录和生化预测因子，这些因子可能指导未来生物标志物的开发。最后，由于COVID-19大流行，如果无法亲自会面，本研究将允许通过视频或电话联系进行知情同意过程和随访访视。总的来说，本研究旨在确定至少一种有效的药物治疗PTSD相关的失眠，并可能产生明确的负面数据，以减少无效失眠药物的使用。
There are currently no validated pharmacotherapies for posttraumatic stress disorder (PTSD)-related insomnia. The purpose of the National Adaptive Trial for PTSD-Related Insomnia (NAP Study) is to efficiently compare to placebo the effects of three insomnia medications with different mechanisms of action that are already prescribed widely to veterans diagnosed with PTSD within U.S. Department of Veterans Affairs (VA) Medical Centers. This study plans to enroll 1224 patients from 34 VA Medical Centers into a 12- week prospective, randomized placebo-controlled clinical trial comparing trazodone, eszopiclone, and gabapentin. The primary outcome measure is insomnia, assessed with the Insomnia Severity Index. A novel aspect of this study is its adaptive design. At the recruitment midpoint, an interim analysis will be conducted to inform a decision to close recruitment to any “futile” arms (i.e. arms where further recruitment is very unlikely to yield a significant result) while maintaining the overall study recruitment target. This step could result in the enrichment of the remaining study arms, enhancing statistical power for the remaining comparisons to placebo. This study will also explore clinical, actigraphic, and biochemical predictors of treatment response that may guide future biomarker development. Lastly, due to the COVID-19 pandemic, this study will allow the consenting process and follow-up visits to be conducted via video or phone contact if in-person meetings are not possible. Overall, this study aims to identify at least one effective pharmacotherapy for PTSD-related insomnia, and, perhaps, to generate definitive negative data to reduce the use of ineffective insomnia medications.National clinical trial (nct) identified numberNCT03668041