Peters-Strickland Timothy, Baker Ross A, Such Pedro, Zhang Peter, Madera Jessica J
Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
Neuropsychiatr Dis Treat. 2019 Jun 24;15:1659-1669. doi: 10.2147/NDT.S198241. eCollection 2019.
To evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena) on personal and social functioning in patients with schizophrenia in both the acute treatment and maintenance therapy settings.
Post hoc analyses were conducted on data from Study 291 (NCT01663532), a 12-week, randomized, double-blind, placebo-controlled trial conducted in patients who were experiencing an acute psychotic episode, and Study 248 (NCT00731549), a 52-week open-label extension of two randomized, controlled trials of AOM 400 as maintenance therapy. Assessment of functioning was made using the Personal and Social Performance (PSP) scale. In Study 291, results were stratified by age (≤35 years or >35 years).
In Study 291, 340 patients were included in the analysis (n=168 randomized to AOM 400 [n=49 aged ≤35 years, n=119 aged >35 years]; n=172 randomized to placebo [n=54 aged ≤35 years, n=118 aged >35 years]). In Study 248, 1,081 patients entered the open-label maintenance phase and 858 completed the study. In Study 291, AOM 400, compared with placebo, resulted in a significant increase (improvement) in PSP scores based on LSM (SE) changes from baseline to Week 12 in patients aged ≤35 years (20.6 [1.9] for AOM 400 vs 9.5 [2.4] for placebo; =0.001) and a numerically (but not significantly) larger increase in PSP scores in patients aged >35 years (16.1 [1.7] for AOM 400 vs 12.5 [1.9] for placebo; =0.093). Improvements in both age groups met criteria for a minimally important clinical difference (7-10 points). In Study 248, AOM 400 resulted in either numerical improvements (increases) from baseline in PSP total score or maintenance of stable baseline values throughout the study.
AOM 400 was effective in improving personal and social functioning during acute treatment and maintaining function during long-term treatment.
评估每月一次服用400mg阿立哌唑（AOM 400；阿立哌唑长效注射剂）对精神分裂症患者在急性治疗期和维持治疗期个人及社会功能的影响。
对研究291（NCT01663532）和研究248（NCT00731549）的数据进行事后分析。研究291是一项为期12周的随机、双盲、安慰剂对照试验，纳入正经历急性精神病发作的患者；研究248是AOM 400作为维持治疗的两项随机对照试验的52周开放标签扩展试验。使用个人和社会表现（PSP）量表评估功能。在研究291中，结果按年龄（≤35岁或>35岁）分层。
在研究291中，340例患者纳入分析（n = 168随机分配至AOM 400组[n = 49例年龄≤35岁，n = 119例年龄>年龄35岁]；n = 172随机分配至安慰剂组[n = 54例年龄≤35岁，n = 118例年龄>35岁]）。在研究248中，1081例患者进入开放标签维持期，858例完成研究。在研究291中，与安慰剂相比，AOM 400使年龄≤35岁患者从基线到第12周基于LSM（SE）变化的PSP评分显著增加（改善）（AOM 400为20.6[1.9]，安慰剂为9.5[2.4]；P = 0.001），年龄>35岁患者的PSP评分增加幅度在数值上更大（但无显著差异）（AOM 400为16.1[1.7]，安慰剂为12.5[1.9]；P = 0.093）。两个年龄组的改善均达到最小重要临床差异标准（7 - 10分）。在研究248中，AOM 400导致PSP总分从基线有数值上的改善（增加）或在整个研究期间维持稳定的基线值。
AOM 400在急性治疗期间有效改善个人和社会功能，并在长期治疗期间维持功能。
