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首页> 外文期刊>Neuropsychiatric Disease and Treatment >Adjunctive brexpiprazole in patients with major depressive disorder and anxiety symptoms: post hoc analyses of three placebo-controlled studies
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Adjunctive brexpiprazole in patients with major depressive disorder and anxiety symptoms: post hoc analyses of three placebo-controlled studies

机译：患有严重抑郁症和焦虑症状的患者使用辅助性brexpiprazole：三项安慰剂对照研究的事后分析

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Objective: Episodes of major depressive disorder (MDD) characterized by high levels of anxiety symptoms are less likely to respond to some forms of antidepressant treatment (ADT). This report examines the effects of adjunctive brexpiprazole on depressive symptoms among patients with MDD and anxiety symptoms. Materials and methods: This was a post hoc analysis of 1,171 patients from the 6-week, randomized, double-blind phases of three studies in adults with MDD and inadequate response to ADTs (NCT01360645, NCT01360632, NCT02196506). Data were pooled for brexpiprazole 2–3?mg/day and for placebo (adjunct to ADT). Montgomery–?sberg Depression Rating Scale Total score changes were assessed in subgroups of patients with and without anxious distress (based on proxies for the Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition criteria) and anxious depression (defined as a Hamilton Depression Rating Scale Anxiety/somatization factor score of ≥7). Safety was assessed by the incidence of treatment-emergent adverse events (TEAEs). Results: Benefits were seen for adjunctive brexpiprazole (compared with adjunctive placebo) in both anxiety definition subgroups. For patients with anxious distress, the least squares mean difference (95% CI) at week 6 was -3.00 (-4.29, -1.71; P 0.0001) and, for those without anxious distress, was -1.38 (-2.71, -0.05; P =0.043). For patients with anxious depression, the difference was -2.19 (-3.60, -0.78; P =0.0023), compared with -2.34 (-3.58, -1.10; P =0.0002) for those without anxious depression. The most common TEAEs among patients with anxiety symptoms receiving ADT + brexpiprazole were akathisia, headache, restlessness, somnolence, and weight increase. There were no clinically meaningful differences in the rates of these TEAEs according to the presence or absence of anxiety symptoms. Conclusion: Adjunctive brexpiprazole 2–3 mg/day may be efficacious in reducing depressive symptoms, and was well tolerated, in patients with clinically relevant anxiety symptoms.
机译：目的：以高度焦虑症状为特征的重性抑郁症（MDD）发作对某些形式的抗抑郁治疗（ADT）反应的可能性较小。本报告探讨了辅助性布雷普拉唑对MDD和焦虑症患者抑郁症状的影响。材料和方法：这是一项对三项研究的1,171名患者进行的事后分析，这些研究来自于6周，随机，双盲的3项成人MDD且对ADTs反应不良的研究（NCT01360645，NCT01360632，NCT02196506）。汇总了2-3毫克/天的brexpiprazole和安慰剂（与ADT一起使用）的数据。蒙哥马利–？sberg抑郁量表对患有和不患有焦虑困扰（根据《精神障碍诊断和统计手册》第五版的标准）和焦虑抑郁症（定义为汉密尔顿抑郁量表）的患者亚组评估总分变化焦虑/躯体化因子得分≥7）。通过治疗紧急不良事件（TEAE）的发生率评估安全性。结果：在两个焦虑症定义亚组中均观察到了辅助性布立哌唑（与辅助性安慰剂相比）的获益。对于焦虑困扰的患者，第6周的最小二乘均方差（95％CI）为-3.00（-4.29，-1.71; P <0.0001），而对于那些没有焦虑困扰的患者，其最小均方差为-1.38（-2.71，-0.05 ; P ＝ 0.043）。对于焦虑抑郁症患者，差异为-2.19（-3.60，-0.78; P = 0.0023），而对于没有焦虑抑郁症的患者，差异为-2.34（-3.58，-1.10; P = 0.0002）。在接受ADT + brexpiprazole治疗的焦虑症患者中，最常见的TEAE是静坐不全，头痛，躁动不安，嗜睡和体重增加。根据是否存在焦虑症状，这些TEAE的发生率在临床上没有有意义的差异。结论：对于临床相关焦虑症状患者，辅助使用brexpiprazole 2-3 mg / day可能有效减轻抑郁症状，并且耐受性良好。

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