Correll Christoph U, Litman Robert E, Filts Yuriy, Llaudó Jordi, Naber Dieter, Torres Ferran, Martínez Javier
Department of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, NY, USA.
Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
NPJ Schizophr. 2020 Nov 25;6(1):37. doi: 10.1038/s41537-020-00127-y.
To evaluate the efficacy and safety of Risperidone ISM against placebo in patients with acute exacerbation of schizophrenia. A multicenter, randomized, double-blind, placebo-controlled study was conducted between June 2017 and December 2018 (NCT03160521). Eligible patients received once-monthly intramuscular injections of Risperidone ISM (75 or 100 mg) or placebo for 12 weeks. The primary efficacy outcome was change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 12. The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) score. Altogether, 438 patients were randomized (1:1:1) and 390 included in the modified ITT efficacy set. The PANSS total score (mean difference, 95% CI) improved significantly from baseline to day 85 with Risperidone ISM 75 and 100 mg, with placebo-adjusted differences of -13.0 (95% CI, -17.3 to -8.8); (p < 0.0001), and -13.3 (-17.6 to -8.9); (p < 0.0001), respectively. Significantly improved mean changes were also obtained for CGI-S score from baseline to day 85 for both doses of Risperidone ISM compared with placebo -0.7 (-1.0 to -0.5); p < 0.0001, for both doses. The statistically significant improvement for both efficacy outcomes were observed as early as 8 days after first injection. The most frequently reported treatment-emergent adverse events were increased blood prolactin (7.8%), headache (7.3%), hyperprolactinemia (5%), and weight increase (4.8%). Neither new nor unexpected relevant safety information was recorded. Risperidone ISM provided rapid and progressive reduction of symptoms in patients with acutely exacerbated schizophrenia without need of oral risperidone supplementation or loading doses. Both doses were safe and well tolerated.
评估利培酮长效注射剂（Risperidone ISM）对比安慰剂治疗精神分裂症急性加重期患者的疗效和安全性。于2017年6月至2018年12月开展了一项多中心、随机、双盲、安慰剂对照研究（NCT03160521）。符合条件的患者每月接受一次肌肉注射利培酮长效注射剂（75或100毫克）或安慰剂，为期12周。主要疗效指标是从基线至第12周阳性和阴性症状量表（PANSS）总分的变化。关键次要疗效指标是临床总体印象-疾病严重程度量表（CGI-S）评分相对于基线的变化。总共438例患者被随机分组（1:1:1），390例纳入改良意向性治疗疗效集。利培酮长效注射剂75毫克和100毫克组从基线至第85天PANSS总分（平均差值，95%置信区间）均显著改善，与安慰剂调整后的差值分别为-13.0（95%置信区间，-17.3至-8.8）；（p＜0.0001），以及-13.3（-17.6至-8.9）；（p＜0.0001）。与安慰剂相比，两种剂量的利培酮长效注射剂从基线至第85天CGI-S评分的平均变化也显著改善，两种剂量均为-0.7（-1.0至-0.5）；p＜0.0001。在首次注射后8天就观察到两种疗效指标的统计学显著改善。最常报告的治疗中出现的不良事件为血催乳素升高（7.8%）、头痛（7.3%）、高催乳素血症（5%）和体重增加（4.8%）。未记录到新的或意外的相关安全信息。利培酮长效注射剂可使精神分裂症急性加重期患者的症状迅速且逐步减轻，无需补充口服利培酮或给予负荷剂量。两种剂量均安全且耐受性良好。
