Real-world effectiveness and safety of aripiprazole augmentation therapy in patients with major depressive disorder

<b>Aims:</b> Augmentation therapy is an option for patients with major depressive disorder who do respond sufficiently to adequate dosages of selective serotonin reuptake inhibitors or serotonin–norepinephrine reuptake inhibitors, but little is known about application of this strategy in everyday practice. <b>Methods:</b> This prospective, multi-center, observational study investigated the effectiveness and safety of aripiprazole augmentation in Japanese patients with inadequate response to conventional antidepressant therapy in real-world clinical practice. The primary endpoint was mean change in the (Japanese version) Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to study end. Safety was assessed by monitoring adverse events. <b>Results:</b> There were 1103 patients in the safety population and 1090 patients in the effectiveness population. Mean change in the MADRS total score at study end was –14.9 ± 12.3 (<i>p</i> <b>Conclusions:</b> Aripiprazole augmentation therapy appears to be effective and safe in Japanese patients with depression/depressive symptoms treated in everyday clinical practice, taking into account factors associated with achieving remission.

<b>研究目的:</b> 对于足量使用选择性5-羟色胺再摄取抑制剂（selective serotonin reuptake inhibitors）或5-羟色胺-去甲肾上腺素再摄取抑制剂（serotonin–norepinephrine reuptake inhibitors）后获得充分应答的重度抑郁症患者，增效治疗是一种可选方案，但目前对于该策略在日常临床实践中的应用情况尚不清楚。<b>研究方法:</b> 本项前瞻性多中心观察性研究，探讨真实世界临床实践中，阿立哌唑（aripiprazole）增效治疗对常规抗抑郁治疗应答不佳的日本抑郁症患者的有效性与安全性。主要终点为从基线至研究结束时，日文版蒙哥马利-阿斯伯格抑郁评定量表（Montgomery-Åsberg Depression Rating Scale, MADRS）总分的平均变化值。安全性通过监测不良事件进行评估。<b>研究结果:</b> 安全性分析人群共纳入1103例患者，有效性分析人群共纳入1090例患者。研究结束时，蒙哥马利-阿斯伯格抑郁评定量表总分的平均变化值为–14.9 ± 12.3（*p* <）<b>研究结论:</b> 阿立哌唑增效治疗在日常临床实践中接受治疗的日本抑郁症/抑郁症状患者中显示出良好的有效性与安全性，该分析同时纳入了与达到临床缓解相关的影响因素。