Han Changsu, Wang Sheng-Min, Kwak Kyung-Phil, Won Wang-Yeon, Lee HwaYoung, Chang Chia Ming, Tang Tze Chun, Pae Chi-Un
Department of Psychiatry, College of Medicine, Korea University, Seoul, South Korea.
Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, South Korea.
J Psychiatr Res. 2015 Jul-Aug;66-67:84-94. doi: 10.1016/j.jpsychires.2015.04.020. Epub 2015 May 5.
No study has directly compared the efficacy and tolerability of aripiprazole augmentation (AA) and antidepressant switching (SW) in patients with major depressive disorder (MDD). This is the first 6-week, randomized, rater-blinded, direct comparison study between AA and SW in outpatients. An inadequate response to antidepressants was defined as a total score ≥ 14 on the Hamilton Depression Rating Scale-item 17 (HDRS-17) despite adequate antidepressant dosage for at least 6 weeks in the current depressive episode. The primary endpoint was change in the total score of the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to the end of treatment. Secondary efficacy measures included the response and remission rates as priori defined at the end of treatment: changes in total scores of the HDRS-17, Iowa Fatigue Scale (IFS), and Sheehan Disability Scale (SDS) from baseline to the end of treatment and the proportion of patients who scored 1 or 2 on the Clinical Global Impression-Improvement Score (CGI-I) at the end of treatment. Tolerability was assessed with the Barnes Akathisia Rating Scale (BARS) and Arizona Sexual dysfunction scale (ASEX), and the numbers of adverse events were compared between the two groups. A total of 101 patients were randomized to either AA (n = 52) or SW (n = 49). The mean change in the MADRS score from baseline was significantly higher in the AA, with a difference in magnitude of -8.7 (p < 0.0001). The intergroup difference was first evident in week 2. The numbers of responders (p = 0.0086) and remitters (p = 0.0005) were also significantly higher in the AA (60% and 54%, respectively) compared with the SW (32.6% and 19.6%, respectively). On most secondary endpoints, AA showed better clinical outcomes compared to SW. The tolerability profiles were comparable between the two groups. Overall, AA yielded potentially beneficial clinical outcomes compared to SW. Given the methodological shortcomings of the present study, adequately powered, more rigorously controlled clinical trials are strongly warranted to confirm the present findings.
尚无研究直接比较阿立哌唑增效治疗（AA）与抗抑郁药换药治疗（SW）对重度抑郁症（MDD）患者的疗效和耐受性。这是第一项针对门诊患者进行的为期6周的、随机、评估者盲法的AA与SW的直接比较研究。对当前抑郁发作期至少6周给予足够剂量抗抑郁药治疗后，汉密尔顿抑郁量表第17项（HDRS-17）总分≥14分被定义为对抗抑郁药反应不足。主要终点是蒙哥马利-Åsberg抑郁量表（MADRS）总分从基线到治疗结束的变化。次要疗效指标包括治疗结束时预先定义的缓解率和有效率：HDRS-17、爱荷华疲劳量表（IFS）和希恩功能障碍量表（SDS）总分从基线到治疗结束的变化，以及治疗结束时临床总体印象改善量表（CGI-I）评分为1或2的患者比例。用巴恩斯静坐不能评定量表（BARS）和亚利桑那性功能障碍量表（ASEX）评估耐受性，并比较两组不良事件的数量。总共101例患者被随机分为AA组（n = 52）或SW组（n = 49）。AA组MADRS评分从基线的平均变化显著更高，幅度差异为-8.7（p < 0.0001）。组间差异在第2周首次显现。AA组的有效者（p = 0.0086）和缓解者（p = 0.0005）数量也显著高于SW组（分别为60%和54%）与SW组（分别为32.6%和19.6%）。在大多数次要终点上，与SW组相比，AA组显示出更好的临床结果。两组的耐受性概况相当。总体而言，与SW组相比，AA组产生了潜在有益的临床结果。鉴于本研究的方法学缺陷，强烈需要进行有足够效力、更严格对照的临床试验来证实本研究结果。
