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心理健康临床试验中是否存在优先级转变?

Is There a Priority Shift in Mental Health Clinical Trials?

作者信息

Anand Vibha, Ghosh Soumya, Anand Amit

机构信息

IBM T.J. Watson Research Center, Cambridge, MA, USA.

Center for Behavioral Health, Cleveland Clinic, Cleveland, OH, USA.

出版信息

Stud Health Technol Inform. 2017;245:280-284.

PMID:29295099
Abstract

Mental health is the largest cost driver of healthcare. ClinicalTrials.gov is a web-based registry of trials conducted in human participants worldwide and serves as an important resource for both practice and research. We use the registry and dynamic topic modeling (DTM) methods to discover hidden topics and their evolution over last 17 years in trials in bipolar disorders. Our model suggests a "priority shift" from drugs to device and among populations studied in mental health trials. For example, transcranial magnetic stimulation for treatment resistant depression (TMS for TRD) trials have increased (χ = 52.99, p < 0.001, n = 187) while standardized drug safety and efficacy trials have remained constant (χ = 0.72, p = 0.39, n = 101) and more trials focused on pediatric and adolescents (χ = 2.98, p = 0.08, n = 133) may have been conducted since FDAAA 2007. We also derive unique data-driven insights in the discovered topic areas in this model based study.

摘要

心理健康是医疗保健中最大的成本驱动因素。ClinicalTrials.gov是一个基于网络的全球人体试验注册库,是实践和研究的重要资源。我们使用该注册库和动态主题建模(DTM)方法来发现双相情感障碍试验中隐藏的主题及其在过去17年中的演变。我们的模型表明,在心理健康试验所研究的人群中,出现了从药物到设备的“优先级转移”。例如,治疗难治性抑郁症的经颅磁刺激(TRD的TMS)试验有所增加(χ = 52.99,p < 0.001,n = 187),而标准化药物安全性和有效性试验保持不变(χ = 0.72,p = 0.39,n = 101),并且自2007年《食品和药物管理局修正法案》(FDAAA)以来,可能开展了更多针对儿童和青少年的试验(χ = 2.98,p = 0.08,n = 133)。在这项基于模型的研究中,我们还在发现的主题领域中获得了独特的数据驱动见解。

相似文献

1
Is There a Priority Shift in Mental Health Clinical Trials?心理健康临床试验中是否存在优先级转变?
Stud Health Technol Inform. 2017;245:280-284.
2
Controversy: Repetitive transcranial magnetic stimulation or transcranial direct current stimulation shows efficacy in treating psychiatric diseases (depression, mania, schizophrenia, obsessive-complusive disorder, panic, posttraumatic stress disorder).争议:重复经颅磁刺激或经颅直流电刺激在治疗精神疾病(抑郁症、躁狂症、精神分裂症、强迫症、惊恐症、创伤后应激障碍)方面显示出疗效。
Brain Stimul. 2009 Jan;2(1):14-21. doi: 10.1016/j.brs.2008.06.001. Epub 2008 Jun 27.
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Med J Aust. 2019 Nov;211 Suppl 9:S3-S46. doi: 10.5694/mja2.50383.
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Methodological issues and controversies in clinical trials with child and adolescent patients with bipolar disorder: report of a consensus conference.双相情感障碍儿童和青少年患者临床试验中的方法学问题与争议:共识会议报告
J Child Adolesc Psychopharmacol. 2003 Spring;13(1):13-27. doi: 10.1089/104454603321666162.
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The Effects of Transcranial Magnetic Stimulation on Cognitive Functioning in Bipolar Depression: A Systematic Review.经颅磁刺激对双相抑郁症认知功能的影响:一项系统评价。
Psychiatr Danub. 2022 Sep;34(Suppl 8):179-188.
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Clinical Trials.Gov: A Topical Analyses.临床试验.gov:专题分析
AMIA Jt Summits Transl Sci Proc. 2017 Jul 26;2017:37-47. eCollection 2017.
7
Trends in US pediatric mental health clinical trials: An analysis of ClinicalTrials.gov from 2007-2018.美国儿科心理健康临床试验趋势:对 2007 年至 2018 年 ClinicalTrials.gov 的分析。
PLoS One. 2021 Apr 1;16(4):e0248898. doi: 10.1371/journal.pone.0248898. eCollection 2021.
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Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study.FDAAA 前后支持 FDA 批准神经精神药物的临床试验的注册、结果报告和发表偏倚:一项回顾性队列研究
Trials. 2018 Oct 23;19(1):581. doi: 10.1186/s13063-018-2957-0.
9
Repetitive transcranial magnetic stimulation: perspectives for application in the treatment of bipolar and unipolar disorders.重复经颅磁刺激:用于治疗双相情感障碍和单相情感障碍的应用前景
Bipolar Disord. 1999 Dec;1(2):73-80. doi: 10.1034/j.1399-5618.1999.010203.x.
10
ECNP consensus meeting. Bipolar depression. Nice, March 2007.欧洲神经精神药理学会共识会议。双相抑郁症。英国尼斯,2007年3月。
Eur Neuropsychopharmacol. 2008 Jul;18(7):535-49. doi: 10.1016/j.euroneuro.2008.03.003. Epub 2008 May 23.

引用本文的文献

1
Trends in US pediatric mental health clinical trials: An analysis of ClinicalTrials.gov from 2007-2018.美国儿科心理健康临床试验趋势:对 2007 年至 2018 年 ClinicalTrials.gov 的分析。
PLoS One. 2021 Apr 1;16(4):e0248898. doi: 10.1371/journal.pone.0248898. eCollection 2021.
2
Trends in mental health clinical research: Characterizing the ClinicalTrials.gov registry from 2007-2018.精神健康临床研究趋势:2007 年至 2018 年临床研究.gov 注册库的特征描述。
PLoS One. 2020 Jun 5;15(6):e0233996. doi: 10.1371/journal.pone.0233996. eCollection 2020.