在精神药物临床试验中使用安慰剂。
Use of Placebo in Clinical Trials of Psychotropic Medication.
机构信息
1 Associate Professor, Discipline of Psychiatry, Memorial University of Newfoundland, St. John's, Newfoundland.
2 Professor, Section of Psychiatry, Northern Ontario School of Medicine, Lakehead and Laurentian Universities, Thunder Bay and Sudbury, Ontario; Vice-President and Chief of Psychiatry, Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario; Chief Scientist, Thunder Bay Regional Health Research Institute, Thunder Bay, Ontario.
出版信息
Can J Psychiatry. 2018 May;63(5):338-341. doi: 10.1177/0706743717752917.
Abstract
This position paper has been substantially revised by the Canadian Psychiatric Association's Research Committee and approved for republication by the CPA's Board of Directors on March 31, 2017. The original position paper was developed by the Scientific and Research Council and approved by the Board of Directors on October 4, 1996.
摘要
本立场文件由加拿大精神病学协会研究委员会进行了实质性修订，并于 2017 年 3 月 31 日获得该协会董事会的重新发布批准。原始立场文件由科学与研究委员会制定，并于 1996 年 10 月 4 日获得董事会批准。
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本文引用的文献
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Increasing placebo response in antipsychotic drug trials: let's stop the vicious circle.在抗精神病药物试验中提高安慰剂反应：让我们停止恶性循环。
Am J Psychiatry. 2013 Nov;170(11):1232-4. doi: 10.1176/appi.ajp.2013.13081129.
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World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.《世界医学协会赫尔辛基宣言：涉及人类受试者的医学研究伦理原则》
JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053.
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Newer generation antidepressants for depressive disorders in children and adolescents.用于儿童和青少年抑郁症的新一代抗抑郁药。
Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD004851. doi: 10.1002/14651858.CD004851.pub3.
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The placebo arm in clinical studies for treatment of psychiatric disorders: a regulatory dilemma.临床研究中治疗精神障碍的安慰剂对照臂：一个监管困境。
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Exploratory analyses of efficacy data from schizophrenia trials in support of new drug applications submitted to the US Food and Drug Administration.支持向美国食品和药物管理局提交新药申请的精神分裂症试验疗效数据的探索性分析。
J Clin Psychiatry. 2012 Jun;73(6):856-64. doi: 10.4088/JCP.11r07539. Epub 2012 May 15.
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Why has the antidepressant-placebo difference in antidepressant clinical trials diminished over the past three decades?为何在过去的三十年中，抗抑郁药临床试验中的抗抑郁药与安慰剂差异缩小了？
CNS Neurosci Ther. 2010 Aug;16(4):217-26. doi: 10.1111/j.1755-5949.2010.00151.x. Epub 2010 Apr 16.
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Does inclusion of a placebo arm influence response to active antidepressant treatment in randomized controlled trials? Results from pooled and meta-analyses.在随机对照试验中，包含安慰剂组是否会影响对活性抗抑郁药治疗的反应？汇总和荟萃分析的结果。
J Clin Psychiatry. 2010 Mar;71(3):270-9. doi: 10.4088/JCP.08r04516blu. Epub 2010 Jan 26.
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Challenges and regulatory experiences with non-inferiority trial design without placebo arm.无安慰剂对照的非劣效性试验设计面临的挑战及监管经验。
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