Efficacy and Safety of Lumateperone for Bipolar Depression and Schizophrenia: A Systematic Review and Meta-Analysis.

IF 4.5 2区 医学 Q1 CLINICAL NEUROLOGY International Journal of Neuropsychopharmacology Pub Date : 2024-11-02 DOI:10.1093/ijnp/pyae052
Hanrui Peng, Kewen Yan, Shouhuan Liu, Xin Li, Xin Wang, Pu Peng, Xueyi Li, Min Wu, Huixue Xu, Qiuxia Wu, Tieqiao Liu, Zejun Li
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Abstract

Objective: This study aimed to evaluate the efficacy and safety of lumateperone in treating bipolar disorder and schizophrenia.

Methods: A comprehensive literature search was conducted across multiple databases and websites from inception to July 16, 2024, to identify both published and unpublished randomized controlled trials (RCTs). Meta-analyses were performed using random-effects or fixed-effects models depending on statistical heterogeneity. Relative risks (RRs) or standardized mean differences (SMDs) with 95% confidence intervals (CIs) were used to summarize the effects.

Results: Out of 931 records screened, seven RCTs (four focusing on bipolar depression and three on schizophrenia) were eligible for inclusion. Lumateperone was efficacious in reducing depressive symptoms in bipolar depression (SMDs = -0.36, 95% CI: -0.59 to -0.13). In treating schizophrenia, lumateperone exhibited a lower combined SMD of -0.14 (95% CI: -0.27 to 0, P = 0.051, I² = 49.6%), showing no significant difference from the placebo group, although the p-value approached significance. The lumateperone group showed significantly higher response rates compared to placebo in both bipolar depression (RRs = 1.27, 95% CI: 1.07 to 1.51) and schizophrenia (RRs = 1.44, 95% CI: 1.12 to 1.86). Common treatment-emergent adverse events included somnolence, dry mouth, dizziness, nausea, and headache (RRs = 1.30 to 3.29). Importantly, lumateperone did not significantly increase extrapyramidal symptoms (EPS, RRs = 1.46, 95% CI: 0.84 to 2.53).

Conclusions: Lumateperone is effective in treating bipolar depression but does not significantly reduce symptom severity in schizophrenia. It has a favorable safety and tolerability profile. However, caution is warranted in interpreting these findings due to the limited number of studies included.

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鲁马培龙治疗双相抑郁症和精神分裂症的疗效和安全性:系统回顾与元分析》。
研究目的本研究旨在评估鲁米培酮治疗双相情感障碍和精神分裂症的疗效和安全性:方法:我们在多个数据库和网站上进行了全面的文献检索,检索时间从开始到2024年7月16日,以确定已发表和未发表的随机对照试验(RCT)。根据统计异质性,采用随机效应或固定效应模型进行元分析。采用相对风险(RRs)或标准化平均差(SMDs)及 95% 置信区间(CIs)来总结疗效:在筛选出的 931 条记录中,有 7 项研究符合纳入条件(其中 4 项针对双相抑郁症,3 项针对精神分裂症)。鲁马培龙对减少双相抑郁症患者的抑郁症状有疗效(SMD = -0.36,95% CI:-0.59 至 -0.13)。在治疗精神分裂症方面,鲁马培龙的综合SMD较低,为-0.14(95% CI:-0.27至0,P = 0.051,I² = 49.6%),与安慰剂组无显著差异,但P值接近显著。在双相抑郁症(RRs = 1.27,95% CI:1.07 至 1.51)和精神分裂症(RRs = 1.44,95% CI:1.12 至 1.86)方面,鲁马培龙组的应答率明显高于安慰剂组。常见的治疗突发不良事件包括嗜睡、口干、头晕、恶心和头痛(RRs = 1.30 至 3.29)。重要的是,鲁马培龙不会明显增加锥体外系症状(EPS,RRs = 1.46,95% CI:0.84 至 2.53):结论:鲁马培龙能有效治疗双相抑郁症,但不能明显减轻精神分裂症的症状严重程度。它具有良好的安全性和耐受性。然而,由于纳入的研究数量有限,在解释这些研究结果时需要谨慎。
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来源期刊
CiteScore
8.40
自引率
2.10%
发文量
230
审稿时长
4-8 weeks
期刊介绍: The central focus of the journal is on research that advances understanding of existing and new neuropsychopharmacological agents including their mode of action and clinical application or provides insights into the biological basis of psychiatric disorders and thereby advances their pharmacological treatment. Such research may derive from the full spectrum of biological and psychological fields of inquiry encompassing classical and novel techniques in neuropsychopharmacology as well as strategies such as neuroimaging, genetics, psychoneuroendocrinology and neuropsychology.
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Efficacy and Safety of Lumateperone for Bipolar Depression and Schizophrenia: A Systematic Review and Meta-Analysis. Risk of cognitive decline among patients with dengue virus infection: A systematic review. Behavioral and neurophysiological signatures of cognitive control in humans and rats. Correction to: Identification of Phosphodiesterase-7A (PDE7A) as a Novel Target for Reducing Ethanol Consumption in Mice. Epigenome-Wide DNA Methylation in Unipolar Depression - Predictive Biomarker of Antidepressant Treatment Response?
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