aAtlanta Institute of Medicine & Research, Atlanta, Georgia Departments of bClinical Development cBiostatistics, Forest Research Institute, Jersey City, New Jersey, USA.
Int Clin Psychopharmacol. 2014 Jul;29(4):197-205. doi: 10.1097/YIC.0000000000000033.
Major depressive disorder (MDD) is characterized by increased rates of impaired function and disability. During antidepressant treatment, functional improvement often lags behind symptomatic resolution, and residual impairment is associated with an increased risk for relapse. When evaluating MDD treatments, it is important to assess not only depressive symptoms but also functional outcomes. In this post-hoc analysis, data from five studies were pooled to examine the effect of levomilnacipran extended-release (ER) versus placebo on functional impairment as measured using the Sheehan Disability Scale. The mean change in the Sheehan Disability Scale total score was significantly greater for levomilnacipran ER versus placebo in the overall pooled population, for both sexes, and across all ages. Statistically significantly higher rates of functional response, functional remission, combined (functional and symptomatic) response, and combined remission were achieved with levomilnacipran ER compared with placebo in the pooled population, as well as in the male, female, younger, and middle-aged population subgroups. The levomilnacipran ER group also showed significantly improved functional outcomes versus placebo regardless of baseline depression severity. Similarly, functional impairment was significantly improved and higher functional and combined response and remission rates were achieved with levomilnacipran ER compared with placebo regardless of the baseline level of functional impairment.
重度抑郁症（MDD）的特征是功能受损和残疾的发生率增加。在抗抑郁治疗期间，功能改善往往滞后于症状缓解，残留的损伤与复发风险增加有关。在评估 MDD 治疗方法时，不仅要评估抑郁症状，还要评估功能结果。在这项事后分析中，汇总了五项研究的数据，以评估左米那普仑缓释剂（ER）与安慰剂相比对 Sheehan 残疾量表测量的功能损伤的影响。在总体汇总人群中，左米那普仑 ER 与安慰剂相比，Sheehan 残疾量表总分的平均变化显著更大，无论性别和所有年龄段均如此。在汇总人群以及男性、女性、年轻和中年亚组中，与安慰剂相比，左米那普仑 ER 组达到了更高的功能反应、功能缓解、联合（功能和症状）反应和联合缓解率。与安慰剂相比，左米那普仑 ER 组无论基线抑郁严重程度如何，功能结果均显著改善。同样，无论基线功能损伤水平如何，与安慰剂相比，左米那普仑 ER 均能显著改善功能损伤，并提高功能和联合反应及缓解率。
