Syed Alveena Batool, Brašić James Robert
Liaquat University of Medical & Health Sciences, Jamshoro, Sindh, Pakistan.
Section of High Resolution Brain Positron Emission Tomography Imaging, Division of Nuclear Medicine and Molecular Imaging, The Russell H. Morgan Department of Radiology and Radiological Science, The Johns Hopkins University School of Medicine, 1101 Saint Paul Street, Unit 1107, Baltimore, MD 21202-2664, USA.
Ther Adv Psychopharmacol. 2021 Jul 31;11:20451253211034019. doi: 10.1177/20451253211034019. eCollection 2021.
Schizophrenia is a devastating mental disorder resulting in marked morbidity and mortality despite the optimal use of all currently available interventions. For this reason, the release of lumateperone (Captyla), also known as ITI-007, an orally administered, atypical antipsychotic provided a welcome novel tool for clinicians to utilize precision medicine to tailor an optimal treatment plan to the specific needs of each person with schizophrenia. To generate a foundation for clinicians to assess the risks and benefits of lumateperone in relation to other interventions for schizophrenia, we conducted a search of items for 'ITI-007' and 'lumateperone' on PubMed, ScienceDirect, Web of Science, Google Scholar, and www.clinicaltrials.gov. We present a critical evaluation of the limited information about lumateperone for schizophrenia, its use approved by the US Food and Drug Administration. Lumateperone merits consideration for patients with treatment-resistant schizophrenia and for patients with schizophrenia who are vulnerable to developing metabolic dysfunction and movement disorders. On the other hand, lumateperone should not be used for (a) women who are pregnant or breastfeeding, children, adolescents, and elderly patients with dementia-related psychosis, (b) patients who are at risk for cerebrovascular diseases, (c) patients who use inducers and moderate or strong inhibitors of the cytochrome P450-3A4 (CYP3A4) isozyme, and (d) patients who use alcohol and other sedating agents. Clinical trials from multiple centers without financial conflicts of interest to market lumateperone are needed to directly compare and contrast lumateperone and other antipsychotic agents to generate trustworthy evidence to be assessed objectively by clinicians treating patients with schizophrenia. Future investigations will provide the foundations to identify the evidence for comprehensive evaluations of the role of lumateperone in the treatment of people with schizophrenia and other conditions.
精神分裂症是一种极具破坏性的精神障碍，尽管目前已充分利用了所有可用的干预措施，但仍会导致显著的发病率和死亡率。因此，鲁马西酮（Captyla，也称为ITI-007）的推出，这是一种口服非典型抗精神病药物，为临床医生提供了一种受欢迎的新型工具，可利用精准医学为每位精神分裂症患者量身定制最佳治疗方案。为了为临床医生评估鲁马西酮相对于其他精神分裂症干预措施的风险和益处奠定基础，我们在PubMed、ScienceDirect、科学网、谷歌学术和www.clinicaltrials.gov上搜索了“ITI-007”和“鲁马西酮”的相关条目。我们对关于鲁马西酮治疗精神分裂症的有限信息进行了批判性评估，其已获美国食品药品监督管理局批准使用。对于难治性精神分裂症患者以及易发生代谢功能障碍和运动障碍的精神分裂症患者，鲁马西酮值得考虑。另一方面，鲁马西酮不应用于以下人群：（a）孕妇或哺乳期妇女、儿童、青少年以及患有痴呆相关精神病的老年患者；（b）有脑血管疾病风险的患者；（c）使用细胞色素P450-3A4（CYP3A4）同工酶诱导剂以及中度或强效抑制剂的患者；（d）使用酒精和其他镇静剂的患者。需要多个无经济利益冲突的中心开展临床试验来推广鲁马西酮，以便直接比较和对比鲁马西酮与其他抗精神病药物，从而产生可供治疗精神分裂症患者的临床医生客观评估的可靠证据。未来的研究将为确定全面评估鲁马西酮在治疗精神分裂症患者及其他病症中的作用的证据奠定基础。
