Channing Jonathan, Mitchell Mary, Cortese Samuele
1 Leigh House Hospital , Winchester, United Kingdom .
2 Center for Innovation in Mental Health , Academic Unit of Psychology.
J Child Adolesc Psychopharmacol. 2018 Sep;28(7):428-436. doi: 10.1089/cap.2018.0046. Epub 2018 Jul 13.
To perform a systematic review of studies of lurasidone in children and/or adolescents and to present a case report aimed to add further insights into its use in clinical practice with youth.
We searched the following databases for empirical studies, of any design, focusing on the pharmacokinetics, efficacy, or safety of lurasidone in children and/or adolescents: Pubmed (Medline), OVID (PsycInfo, EMBASE+EMBASE classic, OVID Medline), Web of Knowledge, and ClinicalTrials.gov (last search January 23, 2018).
From a pool of 301 potentially relevant references, we retained 12 pertinent studies (reported in 28 references), including 1 pharmacokinetics study, 1 double blind randomized controlled trial (RCT) for bipolar depression (BD) with 1 related interim analysis study of its extension phase and 1 related external posterior predictive check study, 1 double blind RCT for schizophrenia with 3 related interim analyses of its extension phase, 1 RCT and 1 case report for autism spectrum disorder, and 2 open-label studies focusing on a variety of disorders. Overall, these studies show that lurasidone is significantly more efficacious than placebo, with moderate effect sizes, and is well tolerated for BD and schizophrenia in youth. Published studies in youth have in general used doses up to 80 mg/day. Our case report suggests that high doses of lurasidone (148 mg/day) were well tolerated and might have contributed to substantial functional improvement in a 14-year old girl with psychosis and a previous history of anorexia nervosa, who had not responded to previous antipsychotics (olanzapine, risperidone, aripiprazole).
There is increasing evidence that lurasidone may be moderately effective and well tolerated for the treatment of BD and psychosis in youth and may have procognitive effects. Our case report suggests that future RCTs should assess the efficacy and tolerability of high doses (>80 mg/day) of lurasidone in youth.
对有关鲁拉西酮治疗儿童和/或青少年的研究进行系统综述，并呈现一份病例报告，旨在为其在青少年临床实践中的应用提供更多见解。
我们检索了以下数据库，以查找关于鲁拉西酮在儿童和/或青少年中的药代动力学、疗效或安全性的任何设计的实证研究：PubMed（Medline）、OVID（PsycInfo、EMBASE + EMBASE经典版、OVID Medline）、Web of Knowledge和ClinicalTrials.gov（最后一次检索于2018年1月23日）。
从301篇潜在相关参考文献中，我们保留了12项相关研究（发表于28篇参考文献中），包括1项药代动力学研究、1项针对双相抑郁（BD）的双盲随机对照试验（RCT）及其延长期的1项相关中期分析研究和1项相关外部事后预测检验研究、1项针对精神分裂症的双盲RCT及其延长期的3项相关中期分析、1项针对自闭症谱系障碍的RCT和1项病例报告，以及2项针对多种疾病的开放标签研究。总体而言，这些研究表明，鲁拉西酮比安慰剂显著更有效，效应大小适中，并且在青少年中对BD和精神分裂症耐受性良好。青少年已发表的研究一般使用剂量高达80毫克/天。我们的病例报告表明，高剂量的鲁拉西酮（148毫克/天）耐受性良好，可能有助于一名患有精神病且有神经性厌食症病史、对先前抗精神病药物（奥氮平、利培酮、阿立哌唑）无反应的14岁女孩在功能上有显著改善。
越来越多的证据表明，鲁拉西酮在治疗青少年BD和精神病方面可能具有中等疗效且耐受性良好，并且可能具有促认知作用。我们的病例报告表明，未来的RCT应评估高剂量（>80毫克/天）鲁拉西酮在青少年中的疗效和耐受性。
