Massachusetts General Hospital, Harvard Medical School, 15 Parkman Street, WACC#812, Boston, MA 02114, USA.
Eur Arch Psychiatry Clin Neurosci. 2011 Apr;261(3):147-56. doi: 10.1007/s00406-010-0149-3. Epub 2010 Sep 22.
The purpose of this analysis was to explore the potential role of anxious MDD as a treatment predictor and moderator in major depressive disorder (MDD) using a large escitalopram clinical trial dataset. Individual patient-level data from 13 double-blinded, randomized, controlled trials in patients with MDD were pooled. Both univariate, last observation carried forward (LOCF) analyses and repeated measurements analyses without imputation (MMRM) were carried out for change in symptom scores, response and remission rates. Of 3,919 patients, 48.0% were classified as having anxious MDD depression (HAMD) somatization/anxiety subscale score ≥7 at baseline. Patients with anxious MDD were less likely to report symptom improvement on some outcome measures than patients without anxious MDD (predictor analysis). Specifically, the difference in response rates for patients with vs. patients without anxious MDD according to the MADRS (55.6% vs. 57.7%, respectively) was not statistically different. However, the difference in remission rates for patients with versus without anxious MDD according to the MADRS (37.6% vs. 44.1%, respectively) was statistically significant. Escitalopram was more effective than placebo, and as effective as the SSRIs and SNRIs, in the treatment of anxious MDD. The present analysis provides some evidence that the presence of an anxious MDD subtype is a predictor of poor response. There was no difference in the response to treatment of patients with or without anxious MDD to escitalopram, SSRIs, or SNRIs. The present analysis did not support the notion that SNRIs are more effective than escitalopram in the treatment of anxious MDD, nor was there evidence to support treatment moderating effects for anxious MDD.
本分析旨在使用大型依地普仑临床研究数据集，探讨焦虑型 MDD 在重度抑郁症（MDD）中的潜在治疗预测和调节作用。对 MDD 患者进行的 13 项双盲、随机、对照试验的个体患者水平数据进行了汇总。采用单变量、末次观察结转（LOCF）分析和未插补的重复测量分析（MMRM）对症状评分、反应和缓解率的变化进行分析。在 3919 例患者中，48.0%的患者在基线时存在焦虑型 MDD 抑郁（HAMD）躯体化/焦虑亚量表评分≥7。与无焦虑 MDD 的患者相比，有焦虑 MDD 的患者在某些结局测量指标上改善的可能性更小（预测分析）。具体来说，根据 MADRS，有焦虑 MDD 患者与无焦虑 MDD 患者的反应率差异（分别为 55.6%和 57.7%）无统计学意义。然而，根据 MADRS，有焦虑 MDD 患者与无焦虑 MDD 患者的缓解率差异（分别为 37.6%和 44.1%）具有统计学意义。依地普仑治疗焦虑型 MDD 的疗效优于安慰剂，与 SSRIs 和 SNRIs 相当。本分析提供了一些证据表明，存在焦虑型 MDD 亚型是反应不佳的预测因素。有或无焦虑 MDD 的患者对依地普仑、SSRIs 或 SNRIs 的治疗反应无差异。本分析不支持 SNRIs 在治疗焦虑型 MDD 方面比依地普仑更有效的观点，也没有证据支持焦虑型 MDD 的治疗调节作用。
