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一项测试抗抑郁效果差异起效时间的理想试验。

An ideal trial to test differential onset of antidepressant effect.

作者信息

Leon A C, Blier P, Culpepper L, Gorman J M, Hirschfeld R M, Nierenberg A A, Roose S P, Rosenbaum J F, Stahl S M, Trivedi M H

机构信息

Department of Biostatistics in Psychiatry, Weill Medical College of Cornell University, New York, NY 10021, USA.

出版信息

J Clin Psychiatry. 2001;62 Suppl 4:34-6; discussion 37-40.

PMID:11229787
Abstract

Although various published clinical studies have suggested that some antidepressants may have a more rapid onset of therapeutic effect than others, none of these trials was adequately designed to measure differential time to onset of effect. Thus, existing data do not support claims that one drug reduces the symptoms of depression faster than another. In this article, we propose a study that would be ideal for measuring comparative onset of antidepressant effect. The key features of this ideal trial include (1) a prospective definition of early onset of action, (2) increased frequency of assessment, (3) a data-analytic approach capable of capturing the dynamic nature of symptomatic change, and (4) various strategies to minimize bias and heterogeneity of response.

摘要

尽管各种已发表的临床研究表明,某些抗抑郁药可能比其他药物具有更快的治疗效果起效时间,但这些试验均未进行充分设计以测量不同药物的起效时间差异。因此,现有数据并不支持一种药物比另一种药物能更快减轻抑郁症状的说法。在本文中,我们提出一项研究,该研究将是测量抗抑郁药效果比较起效时间的理想选择。这项理想试验的关键特征包括:(1)对早期起效的前瞻性定义;(2)增加评估频率;(3)一种能够捕捉症状变化动态性质的数据分析方法;以及(4)各种将反应偏差和异质性降至最低的策略。

相似文献

1
An ideal trial to test differential onset of antidepressant effect.一项测试抗抑郁效果差异起效时间的理想试验。
J Clin Psychiatry. 2001;62 Suppl 4:34-6; discussion 37-40.
2
Measuring onset of antidepressant action in clinical trials: an overview of definitions and methodology.
J Clin Psychiatry. 2001;62 Suppl 4:12-6; discussion 37-40.
3
Methodology to measure onset of action.测量起效时间的方法。
J Clin Psychiatry. 2001;62 Suppl 15:18-21.
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Are two antidepressant mechanisms better than one? Issues in clinical trial design and analysis.两种抗抑郁机制是否优于一种?临床试验设计与分析中的问题。
J Clin Psychiatry. 2004;65 Suppl 4:31-6.
5
Introduction: early onset of antidepressant action.引言:抗抑郁作用的早期起效
J Clin Psychiatry. 2001;62 Suppl 4:3.
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ECT and onset of action.电休克治疗与起效时间。
J Clin Psychiatry. 2001;62 Suppl 4:24-6; discussion 37-40.
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Does early improvement triggered by antidepressants predict response/remission? Analysis of data from a naturalistic study on a large sample of inpatients with major depression.抗抑郁药引发的早期改善能否预测疗效/缓解情况?对大量重度抑郁症住院患者的自然主义研究数据进行分析。
J Affect Disord. 2009 Jun;115(3):439-49. doi: 10.1016/j.jad.2008.10.011. Epub 2008 Nov 22.
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Are 2-week trials sufficient to indicate efficacy?为期两周的试验足以表明疗效吗?
Psychopharmacol Bull. 1995;31(1):41-4.
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Severity of depressive symptoms and response to antidepressants and placebo in antidepressant trials.抑郁症状的严重程度以及在抗抑郁药物试验中对抗抑郁药和安慰剂的反应。
J Psychiatr Res. 2005 Mar;39(2):145-50. doi: 10.1016/j.jpsychires.2004.06.005.
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引用本文的文献

1
The Timing of Antidepressant Effects: A Comparison of Diverse Pharmacological and Somatic Treatments.抗抑郁药起效的时间:不同药物治疗和躯体治疗的比较
Pharmaceuticals (Basel). 2010 Jan 6;3(1):19-41. doi: 10.3390/ph3010019.
2
Rapid onset of antidepressant action: a new paradigm in the research and treatment of major depressive disorder.抗抑郁作用的快速起效:重度抑郁症研究与治疗的新范式
J Clin Psychiatry. 2008 Jun;69(6):946-58. doi: 10.4088/jcp.v69n0610.
3
Time course of clinical response to venlafaxine: relevance of plasma level and chirality.
文拉法辛临床反应的时间进程:血药浓度及手性的相关性
Eur J Clin Pharmacol. 2004 Feb;59(12):883-91. doi: 10.1007/s00228-003-0710-3. Epub 2003 Dec 24.