Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study
Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study
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阿立哌唑每月一次作为 I 型双相情感障碍的维持治疗：一项为期 52 周的多中心开放标签研究
DOI：
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发表时间：
2018
影响因子：
4
通讯作者：
Hiroaki Kawasaki
中科院分区：
文献类型：
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作者：
J. Calabrese;N. Jin;Brian Johnson;P. Such;R. Baker;J. Madera;P. Hertel;Jocelyn Ottinger;J. Amatniek;Hiroaki Kawasaki
背景：长效可注射抗精神病药物阿立哌唑每月一次(AOM 400)，最近被批准用于双相I型障碍(BP-I)的维持治疗。本研究的目的是评价AOM 400作为BP-I长期维持治疗的安全性、耐受性和有效性。方法本开放的多中心研究通过评估安全性和耐受性(主要目标)和疗效(次要目标)来评价AOM 400作为BP-I维持治疗的有效性。这项研究从一项证实AOM 400在维持治疗BP-I中的疗效的随机、安慰剂对照临床试验中招募了AOM 400-初治(“新手”)患者以及有AOM 400经验(“翻转”)的BP-I患者。《临床精神病学杂志》78：324-331,2017)。安全性变量包括治疗紧急不良事件(TEAE)和导致研究中断的TEAE的频率和严重程度。通过在整个维持阶段保持稳定的患者比例以及与基线的平均变化进行评估，包括青年躁狂评定量表(YMRS)、蒙哥马利-阿斯伯格抑郁量表(Montgomery-Asberg)和双相情感障碍临床总体印象-疾病严重程度量表(CGI-BP-S)总分。结果在464例进入维持期的患者中，379例(82%)进入维持期，85例(18%)进入转换期。TEAE在新发患者中比翻转患者更常见。因TEAES而停用的总比率为10.3%(48/464)。在研究期间，YMRS和CGI-BP-S总分的改善保持不变，绝大多数(87.0%)和翻转(97.6%)患者在最后一次访问期间保持稳定。总体而言，在维持阶段对抢救药物的需求很小(<； 10%的患者)。患者的满意度很高，新手和翻身患者都认为AOM 400的副作用负担比以前的药物有很大改善。结论AOM 400是安全、有效的，并且对有BP-I长期维持治疗经验的AOM 400患者都有很好的耐受性。试验注册诊所Trials.gov，NCT01710709
BackgroundThe long-acting injectable antipsychotic aripiprazole once-monthly 400 mg (AOM 400) was recently approved for maintenance treatment of bipolar I disorder (BP-I). The purpose of this study was to evaluate the safety, tolerability, and efficacy of AOM 400 as long-term maintenance treatment for BP-I.MethodsThis open-label multicenter study evaluated the effectiveness of AOM 400 as maintenance treatment for BP-I by assessing safety and tolerability (primary objective) and efficacy (secondary objective). The study enrolled AOM 400-naive (“de novo”) patients as well as AOM 400-experienced (“rollover”) patients with BP-I from a lead-in randomized, placebo-controlled clinical trial that demonstrated the efficacy of AOM 400 in the maintenance treatment of BP-I (Calabrese et al. in J Clin Psychiatry 78:324–331, 2017). Safety variables included frequency and severity of treatment-emergent adverse events (TEAEs) and TEAEs resulting in study discontinuation. Efficacy was assessed by the proportion of patients maintaining stability throughout the maintenance phase, as well as mean changes from baseline in Young Mania Rating Scale (YMRS), Montgomery–Asberg Depression Rating Scale, and Clinical Global Impressions for Bipolar Disorder–Severity of Illness Scale (CGI-BP-S) total scores. Patient acceptability and tolerability of treatment was assessed using the Patient Satisfaction with Medication Questionnaire-Modified.ResultsOf 464 patients entering the maintenance phase, 379 (82%) were de novo and 85 (18%) were rollover. TEAEs were more common in de novo than rollover patients. The overall discontinuation rate due to TEAEs was 10.3% (48/464). Improvements in YMRS and CGI-BP-S total scores were maintained during the study, and the vast majority of both de novo (87.0%) and rollover (97.6%) patients maintained stability through their last visit. Overall, the need for rescue medication during the maintenance phase was minimal (< 10% of patients). Patient satisfaction levels were high, with both de novo and rollover patients rating the side effect burden of AOM 400 as greatly improved relative to previous medications.ConclusionAOM 400 was safe, effective, and well tolerated by both de novo and AOM 400-experienced patients with BP-I for long-term maintenance treatment.Trial registration ClinicalTrials.gov, NCT01710709