Casey D E, Laubmeier K K, Eudicone J M, Marcus R, Berman R M, Rahman Z, Sheehan J
Department of Psychiatry, Oregon Health & Science University, Portland, OR, USA.
Int J Clin Pract. 2014 Nov;68(11):1301-8. doi: 10.1111/ijcp.12480. Epub 2014 Sep 6.
The efficacy of adjunctive aripiprazole in patients with major depressive disorder (MDD) with no improvement after 8 weeks of prior antidepressant monotherapy has not been evaluated.
A post hoc analysis of three similarly designed, randomised, double-blind, placebo-controlled, phase III studies was conducted investigating the efficacy and safety of aripiprazole adjunctive to standard antidepressant treatment (ADT) in MDD patients with a prior inadequate response to one to three ADTs. Minimal improvement to antidepressant monotherapy was defined as a Clinical Global Impressions - Improvement (CGI-I) score of 3 and non-improvement as a CGI-I of 4 at weeks 6 and 8 of antidepressant monotherapy.
The end-point response rate for ADT minimal improvers receiving adjunctive aripiprazole was 38.8% vs. 26.6% for adjunctive placebo (p < 0.05; number needed to treat [NNT] = 9 [95% confidence interval: 4.8-27.7]), and for ADT non-improvers receiving adjunctive aripiprazole was 24.0% vs. 10.3% for adjunctive placebo (p < 0.05; NNT = 8 [95% confidence interval: 4.4-21.5]). ADT minimal improvers and non-improvers demonstrated significant improvements in response vs. ADT alone as early as after 1 and 2 weeks of adjunctive treatment, respectively. The end-point remission rate for ADT minimal improvers receiving adjunctive aripiprazole was 34.2% vs. 21.0% for adjunctive placebo (p < 0.05; NNT = 8), and for ADT non-improvers receiving adjunctive aripiprazole was 16.0% vs. 5.9% for adjunctive placebo (p < 0.05; NNT = 10). The most common adverse events for ADT minimal improvers and non-improvers receiving adjunctive aripiprazole were akathisia, restlessness and insomnia.
Patients with minimal or no improvement after 8 weeks of antidepressant monotherapy significantly benefited from adjunctive aripiprazole treatment, supporting the efficacy of this treatment for MDD patients with all levels of response to ADT.
对于在接受8周抗抑郁药单药治疗后无改善的重度抑郁症（MDD）患者，阿立哌唑辅助治疗的疗效尚未得到评估。
对三项设计相似的随机、双盲、安慰剂对照的III期研究进行事后分析，调查阿立哌唑辅助标准抗抑郁治疗（ADT）对之前对一至三种ADT反应不足的MDD患者的疗效和安全性。抗抑郁药单药治疗的最小改善定义为在抗抑郁药单药治疗第6周和第8周时临床总体印象-改善（CGI-I）评分为3，无改善定义为CGI-I评分为4。
接受阿立哌唑辅助治疗的ADT最小改善者的终点缓解率为38.8%，而接受辅助安慰剂治疗的为26.6%（p<0.05；治疗所需人数[NNT]=9[95%置信区间：4.8-27.7]）；接受阿立哌唑辅助治疗的ADT无改善者的终点缓解率为24.0%，而接受辅助安慰剂治疗的为10.3%（p<0.05；NNT=8[95%置信区间：4.4-21.5]）。ADT最小改善者和无改善者分别在辅助治疗1周和2周后与单纯ADT相比，反应有显著改善。接受阿立哌唑辅助治疗的ADT最小改善者的终点缓解率为34.2%，而接受辅助安慰剂治疗的为21.0%（p<0.05；NNT=8）；接受阿立哌唑辅助治疗的ADT无改善者的终点缓解率为16.0%，而接受辅助安慰剂治疗的为5.9%（p<0.05；NNT=10）。接受阿立哌唑辅助治疗的ADT最小改善者和无改善者最常见的不良事件是静坐不能、烦躁不安和失眠。
抗抑郁药单药治疗8周后改善最小或无改善的患者从阿立哌唑辅助治疗中显著获益，支持该治疗对所有ADT反应水平的MDD患者的疗效。
