Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Corentin-Celton, Service de Psychiatrie, Issy-les-Moulineaux, France.
Université Paris Descartes, PRES Sorbonne Paris Cité, Paris, France.
Aging Ment Health. 2021 Feb;25(2):367-377. doi: 10.1080/13607863.2019.1691146. Epub 2019 Nov 14.
Despite evidence of low representativeness of clinical trial results for depression in adults, the generalizability of clinical trial results for late-life depression is unknown. This study sought to quantify the representativeness of pharmacologic and psychotherapy clinical trial results for late-life unipolar depression.
Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a nationally representative sample of 34,653 adults from the United States population. To assess the generalizability of clinical trial results for late-life depression, we applied a standard set of eligibility criteria representative of pharmacologic and psychotherapy clinical trials to all individuals aged 65 years and older in NESARC with a DSM-IV diagnosis of MDE and no lifetime history of mania/hypomania ( = 273) and in a subsample of individuals seeking help for depression ( = 78).
More than four of ten respondents and about two of ten respondents would have been excluded by at least one exclusion criterion in a typical pharmacologic and psychotherapy efficacy trial, respectively. Similar results (i.e.41.1% and 25.9%, respectively) were found in the subsample of individuals seeking help for depression. Excess percentage of exclusion in typical pharmacologic studies was accounted for by the criterion "significant medical condition". We also found that populations typically included in pharmacologic and psychotherapy clinical trials for late-life unipolar depression may substantially differ.
Psychotherapy trial results may be representative of most patients with late-life unipolar depression in routine clinical practice. By contrast, pharmacologic clinical trials may not be readily generalizable to community samples.
尽管有证据表明成人抑郁症临床试验结果代表性不足，但老年人抑郁症临床试验结果的普遍性尚不清楚。本研究旨在量化药物治疗和心理治疗临床试验结果对老年单相抑郁症的代表性。
数据来自 2004-2005 年全国酒精相关情况和流行病学调查（NESARC），这是一项来自美国人群的具有全国代表性的 34653 名成年人的样本。为了评估老年人抑郁症临床试验结果的普遍性，我们将一组药物治疗和心理治疗临床试验代表性的标准纳入标准应用于 NESARC 中所有年龄在 65 岁及以上、符合 DSM-IV 重性抑郁障碍诊断且无躁狂/轻躁狂病史的个体（ = 273）和寻求抑郁治疗的个体的子样本（ = 78）。
在典型的药物和心理治疗疗效试验中，超过十分之四的受访者和十分之二的受访者将被至少一个排除标准排除在外。在寻求抑郁治疗的个体子样本中也发现了类似的结果（分别为 41.1%和 25.9%）。典型药物研究中排除率过高的原因是“严重医疗状况”这一标准。我们还发现，通常纳入老年单相抑郁症药物和心理治疗临床试验的人群可能有很大差异。
心理治疗试验结果可能代表了大多数在常规临床实践中患有老年单相抑郁症的患者。相比之下，药物临床试验可能不易推广到社区样本。
