Exclusion criteria used in antidepressant efficacy trials - Consistency across studies and representativeness of samples included
Exclusion criteria used in antidepressant efficacy trials - Consistency across studies and representativeness of samples included
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DOI：
10.1097/01.nmd.0000110279.23893.82
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发表时间：
2004-02-01
影响因子：
1.9
通讯作者：
Posternak, MA
中科院分区：
文献类型：
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作者：
Zimmerman, M;Chelminski, I;Posternak, MA
用于选择受试者参与抗抑郁药疗效试验（Aesthetic）的入选和排除标准因研究而异。尚不清楚不同的排除标准集对接受ARF治疗的受试者的代表性有多大影响。在本研究中，我们将最近发表的39项Ablation中使用的入选和排除标准应用于常规临床实践中评价的患者，以评价Ablation中治疗样本的代表性范围和程度。近600例DSM-IV重性抑郁障碍（MDD）或双相抑郁症患者接受了全面的诊断评估。应用AET中使用的入选和排除标准，以确定我们样本中有多少患者符合申请每项AET的条件。在596名抑郁症患者中，大约有六分之一的人被排除在疗效试验之外，因为他们患有双相或精神病性抑郁症亚型。在其余503例非精神病性单相MDD门诊患者中，排除率范围为0%至95.0%（平均= 65.8%）。因此，研究结果表明，有很大的变异性，在普遍性的ARADIX，虽然，在一般情况下，受试者在ARADIX治疗的MDD在以社区为基础的精神科门诊实践中只代表少数患者。
The inclusion and exclusion criteria used to select subjects for participation in antidepressant efficacy trials (AETs) vary from study to study. It is unknown how much impact different sets of exclusion criteria have on the representativeness of subjects treated in AETs. In the present study, we applied the inclusion and exclusion criteria used in 39 recently published AETs to patients evaluated in routine clinical practice to evaluate the range and extent of the representativeness of samples treated in AETs. Nearly 600 patients with DSM-IV major depressive disorder (MDD) or bipolar depression underwent a thorough diagnostic evaluation. Inclusion and exclusion criteria used in AETs were applied to determine how many patients from our sample would have qualified for each AET had they applied. Approximately one sixth of the 596 depressed patients would have been excluded from an efficacy trial because they had a bipolar or psychotic subtype of depression. In the remaining 503 outpatients with nonpsychotic, unipolar MDD, the rates of exclusion ranged from 0% to 95.0% (mean = 65.8%). Thus, the findings suggest that there is much variability in the generalizability of AETs, although, in general, subjects treated in AETs represent only a minority of patients treated for MDD in a community-based psychiatry outpatient practice.