START Clinic for Mood and Anxiety Disorders, Toronto, ON, Canada; Adler Graduate Professional School, Toronto, ON, Canada; Northern Ontario School of Medicine, Thunder Bay, ON, Canada; Department of Psychology, Lakehead University, Thunder Bay, ON, Canada.
Otsuka Canada Pharmaceutical Inc., Saint-Laurent, QC, Canada.
J Affect Disord. 2022 Nov 1;316:201-208. doi: 10.1016/j.jad.2022.08.021. Epub 2022 Aug 13.
Major depressive disorder (MDD) is a clinically heterogenous condition and its treatment should be individualized according to the presence of particular symptom clusters. The aim of this pooled analysis was to investigate the effects of adjunctive brexpiprazole on different symptom clusters in MDD.
Data were included from four similarly designed, short-term, randomized, double-blind, placebo-controlled studies of adjunctive brexpiprazole in adults with MDD and inadequate response to 2-4 antidepressant treatments (ADTs), including 1 administered by investigators. Mean changes from baseline and Cohen's d effect sizes (ES) versus placebo were determined for the following Montgomery-Åsberg Depression Rating Scale symptom clusters: core, anhedonia, dysphoria, retardation, vegetative, loss of interest, and lassitude.
Over 6 weeks, ADT + brexpiprazole 2 mg (n = 486) showed greater improvement than ADT + placebo (n = 585) for all symptom clusters: core (ES = 0.36; p < 0.0001), anhedonia (ES = 0.43; p < 0.0001), dysphoria (ES = 0.27; p < 0.0001), retardation (ES = 0.32; p < 0.0001), vegetative (ES = 0.29; p < 0.0001), loss of interest (ES = 0.30; p < 0.0001), and lassitude (ES = 0.33; p < 0.0001). Improvements of similar magnitude were observed for ADT + brexpiprazole 2-3 mg (n = 770) versus ADT + placebo (n = 788) (ES = 0.24-0.38; all clusters p < 0.0001). In most cases, improvement over ADT + placebo was observed from Week 1 onwards.
Post hoc analysis with no adjunctive active comparator.
Patients receiving adjunctive brexpiprazole versus adjunctive placebo showed improvements across a range of MDD symptom clusters. Improvements appeared early (generally from Week 1) and were maintained over 6 weeks. These data indicate that adjunctive brexpiprazole may benefit multiple subtypes of patient with MDD and inadequate response to ADTs.
重度抑郁症（MDD）是一种临床表现多样的疾病，其治疗应根据特定症状群的存在进行个体化。本汇总分析旨在探讨辅助布瑞哌唑治疗 MDD 不同症状群的疗效。
纳入四项设计相似的短期、随机、双盲、安慰剂对照研究的数据，纳入标准为：成人 MDD 患者在接受 2-4 种抗抑郁药（ADT）治疗后反应不足，其中 1 种由研究者给予，主要终点为：在基线水平的变化，以及与安慰剂相比的 Cohen's d 效应量（ES）。评估的 Montgomery-Åsberg 抑郁评定量表症状群包括：核心症状群、快感缺失症状群、烦躁症状群、迟滞症状群、植物神经症状群、兴趣丧失症状群和乏力症状群。
在 6 周内，ADT+布瑞哌唑 2mg（n=486）治疗组比 ADT+安慰剂（n=585）治疗组在所有症状群方面均有显著改善：核心症状群（ES=0.36；p<0.0001）、快感缺失症状群（ES=0.43；p<0.0001）、烦躁症状群（ES=0.27；p<0.0001）、迟滞症状群（ES=0.32；p<0.0001）、植物神经症状群（ES=0.29；p<0.0001）、兴趣丧失症状群（ES=0.30；p<0.0001）和乏力症状群（ES=0.33；p<0.0001）。ADT+布瑞哌唑 2-3mg（n=770）治疗组与 ADT+安慰剂（n=788）治疗组相比，也观察到类似程度的改善（ES=0.24-0.38；所有症状群 p<0.0001）。在大多数情况下，与 ADT+安慰剂相比，布瑞哌唑治疗组在第 1 周就开始出现改善。
事后分析，无辅助活性对照。
与接受辅助安慰剂相比，接受辅助布瑞哌唑治疗的患者在 MDD 多个症状群方面都有改善。改善情况出现在早期（通常从第 1 周开始），并在 6 周内持续存在。这些数据表明，辅助布瑞哌唑可能使对 ADT 反应不足的多种 MDD 亚型患者受益。
