Nasser Azmi F, Henderson David C, Fava Maurizio, Fudala Paul J, Twumasi-Ankrah Philip, Kouassi Alex, Heidbreder Christian
From the *Global Research & Development, Indivior, Inc, Richmond, VA; †Schizophrenia Clinical and Research Program/Chester M. Pierce, MD Division of Global Psychiatry, Massachusetts General Hospital; ‡Department of Psychiatry, Harvard School of Public Health, Harvard Medical School; §Division of Clinical Research/Department of Psychiatry/Clinical Trials Network and Institute, Massachusetts General Hospital; and ∥Department of Psychiatry, Harvard Medical School, Boston, MA.
J Clin Psychopharmacol. 2016 Apr;36(2):130-40. doi: 10.1097/JCP.0000000000000479.
RBP-7000 is a sustained-release formulation of risperidone for the treatment of schizophrenia, designed to be administered by once-monthly subcutaneous injection using the ATRIGEL delivery system. This study assessed the efficacy, safety, and tolerability of RBP-7000 compared with placebo in subjects with acute exacerbation of schizophrenia. Inpatients were randomly assigned to 8 weeks of double-blind treatment with subcutaneous 90 or 120 mg of RBP-7000 or placebo. Efficacy was evaluated using a mixed-model repeated-measures analysis of the change from baseline (the last nonmissing value before the first dose of RBP-7000 or placebo on day 1) to end of the study in Positive and Negative Syndrome Scale (PANSS) total score (primary efficacy measure) and Clinical Global Impression-Severity score (secondary efficacy measure). The least-squares means from the repeated-measures analysis for the change from baseline in the PANSS total scores for placebo was -9.219 (SE, 1.2162). RBP-7000 produced statistically and clinically significant differences in mean reductions from baseline in PANSS total scores (90-mg RBP-7000 compared with placebo, -6.148 [-9.982 to -2.314], P = 0.0004; 120-mg RBP-7000 compared with placebo, -7.237 [-11.045 to -3.429], P < 0.0001) and significantly improved Clinical Global Impression-Severity scores (90-mg RBP-7000 compared with placebo, -0.350 [-0.557 to -0.143], P = 0.0002; 120-mg RBP-7000 compared with placebo, -0.396 [-0.602 to -0.190], P < 0.0001). Both RBP-7000 dosages were generally well tolerated. The most frequently reported treatment-emergent adverse events in RBP-7000 groups compared with placebo were somnolence, weight gain, and akathisia. The overall incidence of extrapyramidal syndrome-related effects was low and similar across groups. RBP-7000 may provide a new, long-acting alternative treatment for use in adults with acute schizophrenia.
RBP - 7000是一种用于治疗精神分裂症的利培酮缓释制剂，设计通过使用ATRIGEL给药系统每月进行一次皮下注射给药。本研究评估了RBP - 7000与安慰剂相比在精神分裂症急性加重患者中的疗效、安全性和耐受性。住院患者被随机分配接受为期8周的双盲治疗，皮下注射90或120毫克RBP - 7000或安慰剂。使用混合模型重复测量分析评估疗效，该分析从基线（第1天首次注射RBP - 7000或安慰剂前的最后一个非缺失值）到研究结束时的阳性和阴性症状量表（PANSS）总分（主要疗效指标）和临床总体印象-严重程度评分（次要疗效指标）的变化。安慰剂组PANSS总分从基线变化的重复测量分析的最小二乘均值为-9.219（标准误，1.2162）。RBP - 7000在PANSS总分从基线的平均降低方面产生了统计学和临床显著差异（90毫克RBP - 7000与安慰剂相比，-6.148 [-9.982至-2.314]，P = 0.0004；120毫克RBP - 7000与安慰剂相比，-7.237 [-11.045至-3.429]，P < 0.0001），并显著改善了临床总体印象-严重程度评分（90毫克RBP - 7000与安慰剂相比，-0.350 [-0.557至-0.143]，P = 0.0002；120毫克RBP - 7000与安慰剂相比，-0.396 [-0.602至-0.190]，P < 0.0001）。两种RBP - 7000剂量总体耐受性良好。与安慰剂相比，RBP - 7000组最常报告的治疗中出现的不良事件是嗜睡、体重增加和静坐不能。锥体外系综合征相关效应的总体发生率较低且各组相似。RBP - 7000可能为成年急性精神分裂症患者提供一种新的长效替代治疗方法。
