PRIME Care（精神卫生保健中的精确医学） (PRIME Care)
2024年5月23日 更新者：VA Office of Research and Development
该应用程序的重点是为抑郁的退伍军人及其提供者提供精神药物的药物遗传学 (PGx) 测试结果的影响。
该项目的重点是患者和提供者是否以及如何使用在开始抗抑郁药治疗重度抑郁症 (MDD) 时给予他们的基因检测结果，以及使用检测结果是否可以改善患者的预后。
MDD 是与兵役和战斗暴露相关的最常见病症之一，增加了自杀风险，并使常见病程恶化，使其成为功能障碍和死亡的主要原因。
验证 PGx 测试以个性化 MDD 治疗代表了改善退伍军人医疗保健的重要机会。
研究概览
详细说明
背景：在过去几年中，精神药物的商业药物遗传学 (PGx) 检测作为实施“精准医疗”的一种手段已变得普遍，一些保险公司选择承担检测费用。 这些发展给退伍军人健康管理局施加了越来越大的压力，要求其实施以心理健康为重点的 PGxs 计划，尤其是治疗抑郁症，但没有足够的科学研究来支持临床应用的效用。
目标：研究人员提出了一项研究计划，以评估 PGx 测试在治疗重度抑郁症中的效用。
方法：研究人员计划进行多中心随机对照试验（n=2000），患者/提供者二人将被随机分配以在随机化后立即接收 PGx 电池的结果（即 干预组）或照常治疗 6 个月后（即 延迟结果组）该研究将检验以下假设：
- 以 PGx 组合（干预组）的结果为指导的 MDD 退伍军人的抑郁症缓解率高于延迟结果组。 （主要假设）
- 根据商业 PGx 测试结果，干预组中的提供者/患者二人将使用比延迟结果组中的二人更少的具有潜在基因药物相互作用的药物（主要假设）。
研究类型
介入性
注册 (实际的)
1944
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Arkansas
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North Little Rock、Arkansas、美国、72114-1706
- Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
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California
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Palo Alto、California、美国、94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
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San Francisco、California、美国、94121
- San Francisco VA Medical Center, San Francisco, CA
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West Los Angeles、California、美国、90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Colorado
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Aurora、Colorado、美国、80045
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Connecticut
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West Haven、Connecticut、美国、06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Delaware
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Wilmington、Delaware、美国、19805
- Wilmington VA Medical Center, Wilmington, DE
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Florida
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Miami、Florida、美国、33125
- Miami VA Healthcare System, Miami, FL
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Maryland
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Baltimore、Maryland、美国、21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Massachusetts
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Boston、Massachusetts、美国、02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Michigan
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Ann Arbor、Michigan、美国、48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Minnesota
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Minneapolis、Minnesota、美国、55417
- Minneapolis VA Health Care System, Minneapolis, MN
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New Mexico
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Albuquerque、New Mexico、美国、87108-5153
- New Mexico VA Health Care System, Albuquerque, NM
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New York
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Buffalo、New York、美国、14215
- VA Western New York Healthcare System, Buffalo, NY
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North Carolina
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Salisbury、North Carolina、美国、28144
- Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
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Ohio
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Cincinnati、Ohio、美国、45220
- Cincinnati VA Medical Center, Cincinnati, OH
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Cleveland、Ohio、美国、44106
- Louis Stokes VA Medical Center, Cleveland, OH
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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Pittsburgh、Pennsylvania、美国、15240
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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South Carolina
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Charleston、South Carolina、美国、29401-5799
- Ralph H. Johnson VA Medical Center, Charleston, SC
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Texas
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Houston、Texas、美国、77030
- Michael E. DeBakey VA Medical Center, Houston, TX
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Utah
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Salt Lake City、Utah、美国、84148
- VA Salt Lake City Health Care System, Salt Lake City, UT
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Virginia
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Richmond、Virginia、美国、23249
- Hunter Holmes McGuire VA Medical Center, Richmond, VA
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Washington
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Seattle、Washington、美国、98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- PHQ-9 得分 10 并且根据 PHQ-9 标准推定诊断为 MDD
- 至少接受过一次 MDD 治疗（心理治疗或抗抑郁药
- 打算开始用抗抑郁药治疗 MDD，简单的剂量增加将不被视为纳入
- 愿意提供签署的知情同意书以参与研究
排除标准：
目前患有严重的并发精神疾病，即：
- 精神分裂症
- 躁郁症
- 精神病性重度抑郁症
- 边缘或反社会人格障碍
- 饮食失调
- 活跃的酒精或其他药物使用障碍
- 目前使用抗精神病药物
增强疗法，例如：
- 在随机分组时使用两种或多种抗抑郁药（曲唑酮剂量 < 150 毫克/天将不被视为增强药物，因此允许）
- 在同意时需要紧急护理或住院治疗的患者
- 目前被监禁
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：干预组
药物遗传学测试结果将在随机化后 72 小时内提供给提供者，以便于选择抗抑郁药。
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干预是一系列药物遗传学测试结果，主要影响抗抑郁药和其他药物的代谢。
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无干预：延迟结果组
比较组不会在随机化时收到结果，但会在 24 周评估后收到结果（因此结果会延迟）。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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抑郁症缓解
大体时间：随机分组后 24 周
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研究人员将使用患者健康问卷 9 (PHQ9) 作为抑郁症缓解的自我评估指标。
量表范围从 0 到 27，分数越低表明抑郁严重程度越轻。
缓解定义为终点分数为 5 分或更低。
报告的参与者人数是达到症状阈值的人数。
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随机分组后 24 周
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使用较少的具有潜在基因药物相互作用的药物
大体时间：前 30 天内
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研究人员将检查试验前 30 天所开抗抑郁药中可能发生基因药物相互作用的比例。
基因-药物相互作用的机会被分类为 1. 受试者在试验的最初 4 周内没有服用抗抑郁药（无抗抑郁药），2 受试者服用了没有已知基因-药物相互作用的抗抑郁药（无基因相互作用），3 受试者服用了具有中度基因-药物相互作用（中度相互作用）的抗抑郁药。
这些也是不具有 A 级一致性的基因-药物相互作用。
4. 受试者服用了一种具有显着基因-药物相互作用或基因-药物相互作用的抗抑郁药，这些相互作用被认为具有高水平的证据支持其他处方。
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前 30 天内
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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抑郁症严重程度
大体时间：24周
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研究人员将使用患者健康问卷 9 (PHQ9) 作为抑郁症缓解的自我评估指标。
量表范围从 0 到 27，分数越低表明抑郁严重程度越轻。
该措施将使用 PHQ9 作为连续措施。
报告的结果是从基线到 24 周的分数差异。
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24周
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抑郁反应
大体时间：24周
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研究人员将使用患者健康问卷 9 (PHQ9) 作为抑郁症缓解的自我评估指标。
量表范围从 0 到 27，分数越低表明抑郁严重程度越轻。
反应是通过每个时间点的分数从基线下降 50% 来衡量的。
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24周
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：David W. Oslin, MD、Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Yatham LN, Kennedy SH, Parikh SV, Schaffer A, Bond DJ, Frey BN, Sharma V, Goldstein BI, Rej S, Beaulieu S, Alda M, MacQueen G, Milev RV, Ravindran A, O'Donovan C, McIntosh D, Lam RW, Vazquez G, Kapczinski F, McIntyre RS, Kozicky J, Kanba S, Lafer B, Suppes T, Calabrese JR, Vieta E, Malhi G, Post RM, Berk M. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder. Bipolar Disord. 2018 Mar;20(2):97-170. doi: 10.1111/bdi.12609. Epub 2018 Mar 14.
- Polimanti R, Zhang H, Smith AH, Zhao H, Farrer LA, Kranzler HR, Gelernter J. Genome-wide association study of body mass index in subjects with alcohol dependence. Addict Biol. 2017 Mar;22(2):535-549. doi: 10.1111/adb.12317. Epub 2015 Oct 12.
- Stein MB, Chen CY, Jain S, Jensen KP, He F, Heeringa SG, Kessler RC, Maihofer A, Nock MK, Ripke S, Sun X, Thomas ML, Ursano RJ, Smoller JW, Gelernter J; Army STARRS Collaborators. Genetic risk variants for social anxiety. Am J Med Genet B Neuropsychiatr Genet. 2017 Jun;174(4):470-482. doi: 10.1002/ajmg.b.32541. Epub 2017 Apr 27. No abstract available.
- Lippard ETC, Jensen KP, Wang F, Johnston JAY, Spencer L, Pittman B, Gelernter J, Blumberg HP. Genetic variation of ANK3 is associated with lower white matter structural integrity in bipolar disorder. Mol Psychiatry. 2017 Sep;22(9):1225. doi: 10.1038/mp.2017.169. No abstract available.
- Stein MB, Chen CY, Jain S, Jensen KP, He F, Heeringa SG, Kessler RC, Maihofer A, Nock MK, Ripke S, Sun X, Thomas ML, Ursano RJ, Smoller JW, Gelernter J; Army STARRS Collaborators. Genetic risk variants for social anxiety. Am J Med Genet B Neuropsychiatr Genet. 2017 Mar;174(2):120-131. doi: 10.1002/ajmg.b.32520. Erratum In: Am J Med Genet B Neuropsychiatr Genet. 2017 Jun;174(4):470-482.
- Post RM, Leverich GS, McElroy S, Kupka R, Suppes T, Altshuler L, Nolen W, Frye M, Keck P, Grunze H, Hellemann G. Prevalence of axis II comorbidities in bipolar disorder: relationship to mood state. Bipolar Disord. 2018 Jun;20(4):303-312. doi: 10.1111/bdi.12596. Epub 2018 Jan 25.
- Williams LM, Pines A, Goldstein-Piekarski AN, Rosas LG, Kullar M, Sacchet MD, Gevaert O, Bailenson J, Lavori PW, Dagum P, Wandell B, Correa C, Greenleaf W, Suppes T, Perry LM, Smyth JM, Lewis MA, Venditti EM, Snowden M, Simmons JM, Ma J. The ENGAGE study: Integrating neuroimaging, virtual reality and smartphone sensing to understand self-regulation for managing depression and obesity in a precision medicine model. Behav Res Ther. 2018 Feb;101:58-70. doi: 10.1016/j.brat.2017.09.012. Epub 2017 Oct 7.
- Gonzalez R, Suppes T, Zeitzer J, McClung C, Tamminga C, Tohen M, Forero A, Dwivedi A, Alvarado A. The association between mood state and chronobiological characteristics in bipolar I disorder: a naturalistic, variable cluster analysis-based study. Int J Bipolar Disord. 2018 Feb 19;6(1):5. doi: 10.1186/s40345-017-0113-5.
- Vieta E, Berk M, Schulze TG, Carvalho AF, Suppes T, Calabrese JR, Gao K, Miskowiak KW, Grande I. Bipolar disorders. Nat Rev Dis Primers. 2018 Mar 8;4:18008. doi: 10.1038/nrdp.2018.8.
- Post RM, Altshuler LL, Kupka R, McElroy SL, Frye MA, Rowe M, Grunze H, Suppes T, Keck PE Jr, Leverich GS, Nolen WA. Multigenerational transmission of liability to psychiatric illness in offspring of parents with bipolar disorder. Bipolar Disord. 2018 Jun 21. doi: 10.1111/bdi.12668. Online ahead of print.
- Nielsen DA, Spellicy CJ, Harding MJ, Graham DP. Apolipoprotein E DNA methylation and posttraumatic stress disorder are associated with plasma ApoE level: A preliminary study. Behav Brain Res. 2019 Jan 1;356:415-422. doi: 10.1016/j.bbr.2018.05.013. Epub 2018 May 26.
- Ward RE, Cho K, Nguyen XT, Vassy JL, Ho YL, Quaden RM, Gagnon DR, Wilson PWF, Gaziano JM, Djousse L; VA Million Veteran Program. Omega-3 supplement use, fish intake, and risk of non-fatal coronary artery disease and ischemic stroke in the Million Veteran Program. Clin Nutr. 2020 Feb;39(2):574-579. doi: 10.1016/j.clnu.2019.03.005. Epub 2019 Mar 13.
- Raghavan S, Vassy JL, Ho YL, Song RJ, Gagnon DR, Cho K, Wilson PWF, Phillips LS. Diabetes Mellitus-Related All-Cause and Cardiovascular Mortality in a National Cohort of Adults. J Am Heart Assoc. 2019 Feb 19;8(4):e011295. doi: 10.1161/JAHA.118.011295.
- Imran TF, Posner D, Honerlaw J, Vassy JL, Song RJ, Ho YL, Kittner SJ, Liao KP, Cai T, O'Donnell CJ, Djousse L, Gagnon DR, Gaziano JM, Wilson PW, Cho K. A phenotyping algorithm to identify acute ischemic stroke accurately from a national biobank: the Million Veteran Program. Clin Epidemiol. 2018 Oct 16;10:1509-1521. doi: 10.2147/CLEP.S160764. eCollection 2018.
- Leroux AJ, Waid-Ebbs JK, Wen PS, Helmer DA, Graham DP, O'Connor MK, Ray K. An Investigation of Exposure Control Methods With Variable-Length CAT Using the Partial Credit Model. Appl Psychol Meas. 2019 Nov;43(8):624-638. doi: 10.1177/0146621618824856. Epub 2019 Jan 23.
- Nievergelt CM, Maihofer AX, Klengel T, Atkinson EG, Chen CY, Choi KW, Coleman JRI, Dalvie S, Duncan LE, Gelernter J, Levey DF, Logue MW, Polimanti R, Provost AC, Ratanatharathorn A, Stein MB, Torres K, Aiello AE, Almli LM, Amstadter AB, Andersen SB, Andreassen OA, Arbisi PA, Ashley-Koch AE, Austin SB, Avdibegovic E, Babic D, Baekvad-Hansen M, Baker DG, Beckham JC, Bierut LJ, Bisson JI, Boks MP, Bolger EA, Borglum AD, Bradley B, Brashear M, Breen G, Bryant RA, Bustamante AC, Bybjerg-Grauholm J, Calabrese JR, Caldas-de-Almeida JM, Dale AM, Daly MJ, Daskalakis NP, Deckert J, Delahanty DL, Dennis MF, Disner SG, Domschke K, Dzubur-Kulenovic A, Erbes CR, Evans A, Farrer LA, Feeny NC, Flory JD, Forbes D, Franz CE, Galea S, Garrett ME, Gelaye B, Geuze E, Gillespie C, Uka AG, Gordon SD, Guffanti G, Hammamieh R, Harnal S, Hauser MA, Heath AC, Hemmings SMJ, Hougaard DM, Jakovljevic M, Jett M, Johnson EO, Jones I, Jovanovic T, Qin XJ, Junglen AG, Karstoft KI, Kaufman ML, Kessler RC, Khan A, Kimbrel NA, King AP, Koen N, Kranzler HR, Kremen WS, Lawford BR, Lebois LAM, Lewis CE, Linnstaedt SD, Lori A, Lugonja B, Luykx JJ, Lyons MJ, Maples-Keller J, Marmar C, Martin AR, Martin NG, Maurer D, Mavissakalian MR, McFarlane A, McGlinchey RE, McLaughlin KA, McLean SA, McLeay S, Mehta D, Milberg WP, Miller MW, Morey RA, Morris CP, Mors O, Mortensen PB, Neale BM, Nelson EC, Nordentoft M, Norman SB, O'Donnell M, Orcutt HK, Panizzon MS, Peters ES, Peterson AL, Peverill M, Pietrzak RH, Polusny MA, Rice JP, Ripke S, Risbrough VB, Roberts AL, Rothbaum AO, Rothbaum BO, Roy-Byrne P, Ruggiero K, Rung A, Rutten BPF, Saccone NL, Sanchez SE, Schijven D, Seedat S, Seligowski AV, Seng JS, Sheerin CM, Silove D, Smith AK, Smoller JW, Sponheim SR, Stein DJ, Stevens JS, Sumner JA, Teicher MH, Thompson WK, Trapido E, Uddin M, Ursano RJ, van den Heuvel LL, Van Hooff M, Vermetten E, Vinkers CH, Voisey J, Wang Y, Wang Z, Werge T, Williams MA, Williamson DE, Winternitz S, Wolf C, Wolf EJ, Wolff JD, Yehuda R, Young RM, Young KA, Zhao H, Zoellner LA, Liberzon I, Ressler KJ, Haas M, Koenen KC. International meta-analysis of PTSD genome-wide association studies identifies sex- and ancestry-specific genetic risk loci. Nat Commun. 2019 Oct 8;10(1):4558. doi: 10.1038/s41467-019-12576-w.
- Vreeker A, Fears SC, Service SK, Pagani L, Takahashi JS, Araya C, Araya X, Bejarano J, Lopez MC, Montoya G, Montoya CP, Teshiba TM, Escobar J, Cantor RM, Lopez-Jaramillo C, Macaya G, Molina J, Reus VI, Sabatti C, Ophoff RA, Freimer NB, Bearden CE. Genetic analysis of activity, brain and behavioral associations in extended families with heavy genetic loading for bipolar disorder. Psychol Med. 2021 Feb;51(3):494-502. doi: 10.1017/S0033291719003416. Epub 2019 Dec 9.
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- van der Markt A, Klumpers UM, Draisma S, Dols A, Nolen WA, Post RM, Altshuler LL, Frye MA, Grunze H, Keck PE Jr, McElroy SL, Suppes T, Beekman AT, Kupka RW. Testing a clinical staging model for bipolar disorder using longitudinal life chart data. Bipolar Disord. 2019 May;21(3):228-234. doi: 10.1111/bdi.12727. Epub 2018 Dec 12.
- Hidalgo-Mazzei D, Berk M, Cipriani A, Cleare AJ, Florio AD, Dietch D, Geddes JR, Goodwin GM, Grunze H, Hayes JF, Jones I, Kasper S, Macritchie K, McAllister-Williams RH, Morriss R, Nayrouz S, Pappa S, Soares JC, Smith DJ, Suppes T, Talbot P, Vieta E, Watson S, Yatham LN, Young AH, Stokes PRA. Treatment-resistant and multi-therapy-resistant criteria for bipolar depression: consensus definition. Br J Psychiatry. 2019 Jan;214(1):27-35. doi: 10.1192/bjp.2018.257. Epub 2018 Dec 6. Erratum In: Br J Psychiatry. 2019 May;214(5):309.
- Kramer NE, Cosgrove VE, Dunlap K, Subramaniapillai M, McIntyre RS, Suppes T. A clinical model for identifying an inflammatory phenotype in mood disorders. J Psychiatr Res. 2019 Jun;113:148-158. doi: 10.1016/j.jpsychires.2019.02.005. Epub 2019 Feb 10.
- McIntyre RS, Subramaniapillai M, Lee Y, Pan Z, Carmona NE, Shekotikhina M, Rosenblat JD, Brietzke E, Soczynska JK, Cosgrove VE, Miller S, Fischer EG, Kramer NE, Dunlap K, Suppes T, Mansur RB. Efficacy of Adjunctive Infliximab vs Placebo in the Treatment of Adults With Bipolar I/II Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Aug 1;76(8):783-790. doi: 10.1001/jamapsychiatry.2019.0779.
- Hartwell EE, Feinn R, Morris PE, Gelernter J, Krystal J, Arias AJ, Hoffman M, Petrakis I, Gueorguieva R, Schacht JP, Oslin D, Anton RF, Kranzler HR. Systematic review and meta-analysis of the moderating effect of rs1799971 in OPRM1, the mu-opioid receptor gene, on response to naltrexone treatment of alcohol use disorder. Addiction. 2020 Aug;115(8):1426-1437. doi: 10.1111/add.14975. Epub 2020 Feb 11.
- Zhou H, Rentsch CT, Cheng Z, Kember RL, Nunez YZ, Sherva RM, Tate JP, Dao C, Xu K, Polimanti R, Farrer LA, Justice AC, Kranzler HR, Gelernter J; Veterans Affairs Million Veteran Program. Association of OPRM1 Functional Coding Variant With Opioid Use Disorder: A Genome-Wide Association Study. JAMA Psychiatry. 2020 Oct 1;77(10):1072-1080. doi: 10.1001/jamapsychiatry.2020.1206. Erratum In: JAMA Psychiatry. 2021 Feb 1;78(2):224.
- Zhou H, Sealock JM, Sanchez-Roige S, Clarke TK, Levey DF, Cheng Z, Li B, Polimanti R, Kember RL, Smith RV, Thygesen JH, Morgan MY, Atkinson SR, Thursz MR, Nyegaard M, Mattheisen M, Borglum AD, Johnson EC, Justice AC, Palmer AA, McQuillin A, Davis LK, Edenberg HJ, Agrawal A, Kranzler HR, Gelernter J. Genome-wide meta-analysis of problematic alcohol use in 435,563 individuals yields insights into biology and relationships with other traits. Nat Neurosci. 2020 Jul;23(7):809-818. doi: 10.1038/s41593-020-0643-5. Epub 2020 May 25.
- Sun Y, Chang S, Wang F, Sun H, Ni Z, Yue W, Zhou H, Gelernter J, Malison RT, Kalayasiri R, Wu P, Lu L, Shi J. Genome-wide association study of alcohol dependence in male Han Chinese and cross-ethnic polygenic risk score comparison. Transl Psychiatry. 2019 Oct 7;9(1):249. doi: 10.1038/s41398-019-0586-3.
- Cheng Z, Phokaew C, Chou YL, Lai D, Meyers JL, Agrawal A, Farrer LA, Kranzler HR, Gelernter J. A regulatory variant of CHRM3 is associated with cannabis-induced hallucinations in European Americans. Transl Psychiatry. 2019 Nov 18;9(1):309. doi: 10.1038/s41398-019-0639-7.
- Wendt FR, Muniz Carvalho C, Pathak GA, Gelernter J, Polimanti R. Deciphering the Biological Mechanisms Underlying the Genome-Wide Associations between Computerized Device Use and Psychiatric Disorders. J Clin Med. 2019 Nov 21;8(12):2040. doi: 10.3390/jcm8122040.
- Hettema JM, Verhulst B, Chatzinakos C, Bacanu SA, Chen CY, Ursano RJ, Kessler RC, Gelernter J, Smoller JW, He F, Jain S, Stein MB. Genome-wide association study of shared liability to anxiety disorders in Army STARRS. Am J Med Genet B Neuropsychiatr Genet. 2020 Jun;183(4):197-207. doi: 10.1002/ajmg.b.32776. Epub 2019 Dec 30.
- Cox JW, Sherva RM, Lunetta KL, Johnson EC, Martin NG, Degenhardt L, Agrawal A, Nelson EC, Kranzler HR, Gelernter J, Farrer LA. Genome-Wide Association Study of Opioid Cessation. J Clin Med. 2020 Jan 9;9(1):180. doi: 10.3390/jcm9010180.
- Dalvie S, Maihofer AX, Coleman JRI, Bradley B, Breen G, Brick LA, Chen CY, Choi KW, Duncan LE, Guffanti G, Haas M, Harnal S, Liberzon I, Nugent NR, Provost AC, Ressler KJ, Torres K, Amstadter AB, Bryn Austin S, Baker DG, Bolger EA, Bryant RA, Calabrese JR, Delahanty DL, Farrer LA, Feeny NC, Flory JD, Forbes D, Galea S, Gautam A, Gelernter J, Hammamieh R, Jett M, Junglen AG, Kaufman ML, Kessler RC, Khan A, Kranzler HR, Lebois LAM, Marmar C, Mavissakalian MR, McFarlane A, Donnell MO, Orcutt HK, Pietrzak RH, Risbrough VB, Roberts AL, Rothbaum AO, Roy-Byrne P, Ruggiero K, Seligowski AV, Sheerin CM, Silove D, Smoller JW, Stein MB, Teicher MH, Ursano RJ, Van Hooff M, Winternitz S, Wolff JD, Yehuda R, Zhao H, Zoellner LA, Stein DJ, Koenen KC, Nievergelt CM. Genomic influences on self-reported childhood maltreatment. Transl Psychiatry. 2020 Jan 27;10(1):38. doi: 10.1038/s41398-020-0706-0.
- de Araujo CM, Hudziak J, Crocetti D, Wymbs NF, Montalvo-Ortiz JL, Orr C, Albaugh MD, Althoff RR, O'Loughlin K, Holbrook H, Garavan H, Yang BZ, Mostofsky S, Jackowski A, Lee RS, Gelernter J, Kaufman J. Tubulin Polymerization Promoting Protein (TPPP) gene methylation and corpus callosum measures in maltreated children. Psychiatry Res Neuroimaging. 2020 Apr 30;298:111058. doi: 10.1016/j.pscychresns.2020.111058. Epub 2020 Feb 22.
- Munn-Chernoff MA, Johnson EC, Chou YL, Coleman JRI, Thornton LM, Walters RK, Yilmaz Z, Baker JH, Hubel C, Gordon S, Medland SE, Watson HJ, Gaspar HA, Bryois J, Hinney A, Leppa VM, Mattheisen M, Ripke S, Yao S, Giusti-Rodriguez P, Hanscombe KB, Adan RAH, Alfredsson L, Ando T, Andreassen OA, Berrettini WH, Boehm I, Boni C, Boraska Perica V, Buehren K, Burghardt R, Cassina M, Cichon S, Clementi M, Cone RD, Courtet P, Crow S, Crowley JJ, Danner UN, Davis OSP, de Zwaan M, Dedoussis G, Degortes D, DeSocio JE, Dick DM, Dikeos D, Dina C, Dmitrzak-Weglarz M, Docampo E, Duncan LE, Egberts K, Ehrlich S, Escaramis G, Esko T, Estivill X, Farmer A, Favaro A, Fernandez-Aranda F, Fichter MM, Fischer K, Focker M, Foretova L, Forstner AJ, Forzan M, Franklin CS, Gallinger S, Giegling I, Giuranna J, Gonidakis F, Gorwood P, Gratacos Mayora M, Guillaume S, Guo Y, Hakonarson H, Hatzikotoulas K, Hauser J, Hebebrand J, Helder SG, Herms S, Herpertz-Dahlmann B, Herzog W, Huckins LM, Hudson JI, Imgart H, Inoko H, Janout V, Jimenez-Murcia S, Julia A, Kalsi G, Kaminska D, Karhunen L, Karwautz A, Kas MJH, Kennedy JL, Keski-Rahkonen A, Kiezebrink K, Kim YR, Klump KL, Knudsen GPS, La Via MC, Le Hellard S, Levitan RD, Li D, Lilenfeld L, Lin BD, Lissowska J, Luykx J, Magistretti PJ, Maj M, Mannik K, Marsal S, Marshall CR, Mattingsdal M, McDevitt S, McGuffin P, Metspalu A, Meulenbelt I, Micali N, Mitchell K, Monteleone AM, Monteleone P, Nacmias B, Navratilova M, Ntalla I, O'Toole JK, Ophoff RA, Padyukov L, Palotie A, Pantel J, Papezova H, Pinto D, Rabionet R, Raevuori A, Ramoz N, Reichborn-Kjennerud T, Ricca V, Ripatti S, Ritschel F, Roberts M, Rotondo A, Rujescu D, Rybakowski F, Santonastaso P, Scherag A, Scherer SW, Schmidt U, Schork NJ, Schosser A, Seitz J, Slachtova L, Slagboom PE, Slof-Op't Landt MCT, Slopien A, Sorbi S, Swiatkowska B, Szatkiewicz JP, Tachmazidou I, Tenconi E, Tortorella A, Tozzi F, Treasure J, Tsitsika A, Tyszkiewicz-Nwafor M, Tziouvas K, van Elburg AA, van Furth EF, Wagner G, Walton E, Widen E, Zeggini E, Zerwas S, Zipfel S, Bergen AW, Boden JM, Brandt H, Crawford S, Halmi KA, Horwood LJ, Johnson C, Kaplan AS, Kaye WH, Mitchell J, Olsen CM, Pearson JF, Pedersen NL, Strober M, Werge T, Whiteman DC, Woodside DB, Grove J, Henders AK, Larsen JT, Parker R, Petersen LV, Jordan J, Kennedy MA, Birgegard A, Lichtenstein P, Norring C, Landen M, Mortensen PB, Polimanti R, McClintick JN, Adkins AE, Aliev F, Bacanu SA, Batzler A, Bertelsen S, Biernacka JM, Bigdeli TB, Chen LS, Clarke TK, Degenhardt F, Docherty AR, Edwards AC, Foo JC, Fox L, Frank J, Hack LM, Hartmann AM, Hartz SM, Heilmann-Heimbach S, Hodgkinson C, Hoffmann P, Hottenga JJ, Konte B, Lahti J, Lahti-Pulkkinen M, Lai D, Ligthart L, Loukola A, Maher BS, Mbarek H, McIntosh AM, McQueen MB, Meyers JL, Milaneschi Y, Palviainen T, Peterson RE, Ryu E, Saccone NL, Salvatore JE, Sanchez-Roige S, Schwandt M, Sherva R, Streit F, Strohmaier J, Thomas N, Wang JC, Webb BT, Wedow R, Wetherill L, Wills AG, Zhou H, Boardman JD, Chen D, Choi DS, Copeland WE, Culverhouse RC, Dahmen N, Degenhardt L, Domingue BW, Frye MA, Gaebel W, Hayward C, Ising M, Keyes M, Kiefer F, Koller G, Kramer J, Kuperman S, Lucae S, Lynskey MT, Maier W, Mann K, Mannisto S, Muller-Myhsok B, Murray AD, Nurnberger JI, Preuss U, Raikkonen K, Reynolds MD, Ridinger M, Scherbaum N, Schuckit MA, Soyka M, Treutlein J, Witt SH, Wodarz N, Zill P, Adkins DE, Boomsma DI, Bierut LJ, Brown SA, Bucholz KK, Costello EJ, de Wit H, Diazgranados N, Eriksson JG, Farrer LA, Foroud TM, Gillespie NA, Goate AM, Goldman D, Grucza RA, Hancock DB, Harris KM, Hesselbrock V, Hewitt JK, Hopfer CJ, Iacono WG, Johnson EO, Karpyak VM, Kendler KS, Kranzler HR, Krauter K, Lind PA, McGue M, MacKillop J, Madden PAF, Maes HH, Magnusson PKE, Nelson EC, Nothen MM, Palmer AA, Penninx BWJH, Porjesz B, Rice JP, Rietschel M, Riley BP, Rose RJ, Shen PH, Silberg J, Stallings MC, Tarter RE, Vanyukov MM, Vrieze S, Wall TL, Whitfield JB, Zhao H, Neale BM, Wade TD, Heath AC, Montgomery GW, Martin NG, Sullivan PF, Kaprio J, Breen G, Gelernter J, Edenberg HJ, Bulik CM, Agrawal A. Shared genetic risk between eating disorder- and substance-use-related phenotypes: Evidence from genome-wide association studies. Addict Biol. 2021 Jan;26(1):e12880. doi: 10.1111/adb.12880. Epub 2020 Feb 16.
- Muniz Carvalho C, Wendt FR, Maihofer AX, Stein DJ, Stein MB, Sumner JA, Hemmings SMJ, Nievergelt CM, Koenen KC, Gelernter J, Belangero SI, Polimanti R. Dissecting the genetic association of C-reactive protein with PTSD, traumatic events, and social support. Neuropsychopharmacology. 2021 May;46(6):1071-1077. doi: 10.1038/s41386-020-0655-6. Epub 2020 Mar 16.
- Wendt FR, Carvalho CM, Pathak GA, Gelernter J, Polimanti R. Polygenic risk for autism spectrum disorder associates with anger recognition in a neurodevelopment-focused phenome-wide scan of unaffected youths from a population-based cohort. PLoS Genet. 2020 Sep 17;16(9):e1009036. doi: 10.1371/journal.pgen.1009036. eCollection 2020 Sep.
- Hull LE, Lynch KG, Oslin DW. VA Primary Care and Mental Health Providers' Comfort with Genetic Testing: Survey Results from the PRIME Care Study. J Gen Intern Med. 2019 Jun;34(6):799-801. doi: 10.1007/s11606-018-4776-0. No abstract available.
- Chanfreau-Coffinier C, Hull LE, Lynch JA, DuVall SL, Damrauer SM, Cunningham FE, Voight BF, Matheny ME, Oslin DW, Icardi MS, Tuteja S. Projected Prevalence of Actionable Pharmacogenetic Variants and Level A Drugs Prescribed Among US Veterans Health Administration Pharmacy Users. JAMA Netw Open. 2019 Jun 5;2(6):e195345. doi: 10.1001/jamanetworkopen.2019.5345.
- Hull LE, Chanfreau-Coffinier C, Tuteja S, Berlowitz D, Lehmann LS, Oslin DW, Pyne JM, DuVall SL, Lynch JA. Early adoption of pharmacogenetic testing for veterans prescribed psychotropic medications. Pharmacogenomics. 2019 Jul;20(11):781-789. doi: 10.2217/pgs-2019-0065. Epub 2019 Aug 8.
- Oslin DW, Chapman S, Duvall SL, Gelernter J, Ingram EP, Kranzler HR, Lehmann LS, Lynch JA, Lynch KG, Pyne JM, Shih MC, Stone A, Thase ME, Wray LO. Study design and implementation of the PRecision Medicine In MEntal health Care (PRIME Care) Trial. Contemp Clin Trials. 2021 Feb;101:106247. doi: 10.1016/j.cct.2020.106247. Epub 2020 Dec 11.
- Vest BM, Wray LO, Brady LA, Thase ME, Beehler GP, Chapman SR, Hull LE, Oslin DW. Primary care and mental health providers' perceptions of implementation of pharmacogenetics testing for depression prescribing. BMC Psychiatry. 2020 Oct 28;20(1):518. doi: 10.1186/s12888-020-02919-z.
- Ramsey CM, Lynch KG, Gehrman PR, Vairavan S, Narayan VA, Li QS, Oslin DW. Daily steps and depressive symptoms: A longitudinal evaluation of patients with major depressive disorder in the precision medicine in mental health care study. J Affect Disord. 2022 Mar 1;300:334-340. doi: 10.1016/j.jad.2021.12.116. Epub 2022 Jan 1.
- Marees AT, Gamazon ER, Gerring Z, Vorspan F, Fingal J, van den Brink W, Smit DJA, Verweij KJH, Kranzler HR, Sherva R, Farrer L; International Cannabis Consortium; Gelernter J, Derks EM. Post-GWAS analysis of six substance use traits improves the identification and functional interpretation of genetic risk loci. Drug Alcohol Depend. 2020 Jan 1;206:107703. doi: 10.1016/j.drugalcdep.2019.107703. Epub 2019 Nov 4.
- Levey DF, Gelernter J, Polimanti R, Zhou H, Cheng Z, Aslan M, Quaden R, Concato J, Radhakrishnan K, Bryois J, Sullivan PF; Million Veteran Program; Stein MB. Reproducible Genetic Risk Loci for Anxiety: Results From approximately 200,000 Participants in the Million Veteran Program. Am J Psychiatry. 2020 Mar 1;177(3):223-232. doi: 10.1176/appi.ajp.2019.19030256. Epub 2020 Jan 7.
- Polimanti R, Walters RK, Johnson EC, McClintick JN, Adkins AE, Adkins DE, Bacanu SA, Bierut LJ, Bigdeli TB, Brown S, Bucholz KK, Copeland WE, Costello EJ, Degenhardt L, Farrer LA, Foroud TM, Fox L, Goate AM, Grucza R, Hack LM, Hancock DB, Hartz SM, Heath AC, Hewitt JK, Hopfer CJ, Johnson EO, Kendler KS, Kranzler HR, Krauter K, Lai D, Madden PAF, Martin NG, Maes HH, Nelson EC, Peterson RE, Porjesz B, Riley BP, Saccone N, Stallings M, Wall TL, Webb BT, Wetherill L; Psychiatric Genomics Consortium Substance Use Disorders Workgroup; Edenberg HJ, Agrawal A, Gelernter J. Leveraging genome-wide data to investigate differences between opioid use vs. opioid dependence in 41,176 individuals from the Psychiatric Genomics Consortium. Mol Psychiatry. 2020 Aug;25(8):1673-1687. doi: 10.1038/s41380-020-0677-9. Epub 2020 Feb 26.
- Hunter-Zinck H, Shi Y, Li M, Gorman BR, Ji SG, Sun N, Webster T, Liem A, Hsieh P, Devineni P, Karnam P, Gong X, Radhakrishnan L, Schmidt J, Assimes TL, Huang J, Pan C, Humphries D, Brophy M, Moser J, Muralidhar S, Huang GD, Przygodzki R, Concato J, Gaziano JM, Gelernter J, O'Donnell CJ, Hauser ER, Zhao H, O'Leary TJ; VA Million Veteran Program; Tsao PS, Pyarajan S. Genotyping Array Design and Data Quality Control in the Million Veteran Program. Am J Hum Genet. 2020 Apr 2;106(4):535-548. doi: 10.1016/j.ajhg.2020.03.004.
- Ramsey CM, Lynch KG, Thase ME, Gelernter J, Kranzler HR, Pyne JM, Shih MC, Stone A; PRIME Care Executive Committee; Oslin DW. Prevalence of predicted gene-drug interactions for antidepressants in the treatment of major depressive disorder in the Precision Medicine in Mental Health Care Study. J Affect Disord. 2021 Mar 1;282:1272-1277. doi: 10.1016/j.jad.2021.01.034. Epub 2021 Jan 14.
- Oslin DW, Lynch KG, Shih MC, Ingram EP, Wray LO, Chapman SR, Kranzler HR, Gelernter J, Pyne JM, Stone A, DuVall SL, Lehmann LS, Thase ME; PRIME Care Research Group; Aslam M, Batki SL, Bjork JM, Blow FC, Brenner LA, Chen P, Desai S, Dieperink EW, Fears SC, Fuller MA, Goodman CS, Graham DP, Haas GL, Hamner MB, Helstrom AW, Hurley RA, Icardi MS, Jurjus GJ, Kilbourne AM, Kreyenbuhl J, Lache DJ, Lieske SP, Lynch JA, Meyer LJ, Montalvo C, Muralidhar S, Ostacher MJ, Paschall GY, Pfeiffer PN, Prieto S, Przygodzki RM, Ranganathan M, Rodriguez-Suarez MM, Roggenkamp H, Schichman SA, Schneeweis JS, Simonetti JA, Steinhauer SR, Suppes T, Umbert MA, Vassy JL, Voora D, Wiechers IR, Wood AE. Effect of Pharmacogenomic Testing for Drug-Gene Interactions on Medication Selection and Remission of Symptoms in Major Depressive Disorder: The PRIME Care Randomized Clinical Trial. JAMA. 2022 Jul 12;328(2):151-161. doi: 10.1001/jama.2022.9805.
- Ziobrowski HN, Cui R, Ross EL, Liu H, Puac-Polanco V, Turner B, Leung LB, Bossarte RM, Bryant C, Pigeon WR, Oslin DW, Post EP, Zaslavsky AM, Zubizarreta JR, Nierenberg AA, Luedtke A, Kennedy CJ, Kessler RC. Development of a model to predict psychotherapy response for depression among Veterans. Psychol Med. 2023 Jun;53(8):3591-3600. doi: 10.1017/S0033291722000228. Epub 2022 Feb 11.
- Na PJ, De Angelis F, Nichter B, Wendt FR, Krystal JH, Southwick SM, Levey DF, Gelernter J, Polimanti R, Pietrzak RH. Psychosocial moderators of polygenic risk for suicidal ideation: Results from a 7-year population-based, prospective cohort study of U.S. veterans. Mol Psychiatry. 2022 Feb;27(2):1068-1074. doi: 10.1038/s41380-021-01352-2. Epub 2021 Nov 2.
- Tamman AJF, Wendt FR, Pathak GA, Krystal JH, Southwick SM, Sippel LM, Gelernter J, Polimanti R, Pietrzak RH. Attachment Style Moderates Polygenic Risk for Incident Posttraumatic Stress in U.S. Military Veterans: A 7-Year, Nationally Representative, Prospective Cohort Study. Biol Psychiatry. 2022 Apr 1;91(7):637-646. doi: 10.1016/j.biopsych.2021.09.025. Epub 2021 Oct 6.
- Montalvo-Ortiz JL, Gelernter J, Cheng Z, Girgenti MJ, Xu K, Zhang X, Gopalan S, Zhou H, Duman RS, Southwick SM, Krystal JH; Traumatic Stress Brain Research Study Group; Pietrzak RH. Epigenome-wide association study of posttraumatic stress disorder identifies novel loci in U.S. military veterans. Transl Psychiatry. 2022 Feb 17;12(1):65. doi: 10.1038/s41398-022-01822-3.
- Verma A, Huffman JE, Gao L, Minnier J, Wu WC, Cho K, Ho YL, Gorman BR, Pyarajan S, Rajeevan N, Garcon H, Joseph J, McGeary JE, Suzuki A, Reaven PD, Wan ES, Lynch JA, Petersen JM, Meigs JB, Freiberg MS, Gatsby E, Lynch KE, Zekavat SM, Natarajan P, Dalal S, Jhala DN, Arjomandi M, Bonomo RA, Thompson TK, Pathak GA, Zhou JJ, Donskey CJ, Madduri RK, Wells QS, Gelernter J, Huang RDL, Polimanti R, Chang KM, Liao KP, Tsao PS, Sun YV, Wilson PWF, O'Donnell CJ, Hung AM, Gaziano JM, Hauger RL, Iyengar SK, Luoh SW; VA Million Veteran Program COVID-19 Science Initiative. Association of Kidney Comorbidities and Acute Kidney Failure With Unfavorable Outcomes After COVID-19 in Individuals With the Sickle Cell Trait. JAMA Intern Med. 2022 Aug 1;182(8):796-804. doi: 10.1001/jamainternmed.2022.2141.
- Na PJ, Montalvo-Ortiz JL, Nagamatsu ST, Southwick SM, Krystal JH, Gelernter J, Pietrzak RH. Association of Symptoms of Posttraumatic Stress Disorder and GrimAge, an Epigenetic Marker of Mortality Risk, in US Military Veterans. J Clin Psychiatry. 2022 Jul 6;83(4):21br14309. doi: 10.4088/JCP.21br14309. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月15日
初级完成 (实际的)
2021年10月30日
研究完成 (实际的)
2022年3月31日
研究注册日期
首次提交
2017年5月26日
首先提交符合 QC 标准的
2017年5月26日
首次发布 (实际的)
2017年5月31日
研究记录更新
最后更新发布 (实际的)
2024年5月28日
上次提交的符合 QC 标准的更新
2024年5月23日
最后验证
2024年5月1日
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药物和器械信息、研究文件
研究美国 FDA 监管的药品
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在美国制造并从美国出口的产品
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药理学测试的临床试验
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National... 和其他合作者完全的
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National University of Ireland, Galway, IrelandHealth Research Board, Ireland完全的
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PATHUnited States Agency for International Development (USAID); Kintampo Health Research Centre,...完全的
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Rijnstate HospitalRadboud University Medical Center完全的