Efficacy and Safety of Lurasidone in Children and Adolescents With Bipolar I Depression: A Double-Blind, Placebo-Controlled Study
Efficacy and Safety of Lurasidone in Children and Adolescents With Bipolar I Depression: A Double-Blind, Placebo-Controlled Study
复制标题
DOI：
10.1016/j.jaac.2017.10.006
复制
发表时间：
2017-12-01
影响因子：
13.3
通讯作者：
Loebel, Antony
中科院分区：
文献类型：
--
作者：
DelBello, Melissa P.;Goldman, Robert;Loebel, Antony
目的：评估鲁拉西酮在儿童和青少年双相抑郁症中的疗效和安全性。方法：将10至17岁的DSM-5诊断为双相I型抑郁症的患者随机分配至6周双盲治疗组，接受灵活剂量的鲁拉西酮20至80 mg/天。主要终点是儿童抑郁评定量表修订版（CDRS-R）总评分从基线至第6周的变化，通过混合模型重复测量分析进行评价。（n = 175;平均年龄14.2岁;平均剂量33.6 mg/天）或安慰剂（n = 172;平均年龄14.3岁）。第6周时，与安慰剂相比，鲁拉西酮治疗与CDRS-R总分的统计学显著性改善相关（-21.0 vs-15.3; p < .0001;效应量0.45）。鲁拉西酮还与临床总体印象双相抑郁严重程度评分（关键次要指标）以及焦虑、生活质量和整体功能指标的统计学显著性改善相关。鲁拉西酮组的研究完成率为92.0%，安慰剂组为89.7%;两组因不良事件而停药的发生率相同（1.7%）。鲁拉西酮最常见的2起不良事件为恶心和嗜睡。鲁拉西酮治疗对体重和代谢参数的影响很小。结论：在这项安慰剂对照研究中，鲁拉西酮单药治疗（剂量范围为20 - 80 mg/天）可显著减轻双相抑郁儿童和青少年的抑郁症状。鲁拉西酮耐受性良好，对体重和代谢参数的影响极小。
Objective: To evaluate the efficacy and safety of lurasidone in children and adolescents with bipolar depression.Method: Patients 10 to 17 years old with a DSM-5 diagnosis of bipolar I depression were randomized to 6 weeks of double-blind treatment with flexible doses of lurasidone 20 to 80 mg/day. The primary endpoint was change from baseline to week 6 in the Children's Depression Rating Scale-Revised (CDRS-R) total score, evaluated by a mixed-model repeated-measures analysis.Results: A total of 347 patients were randomized and received at least 1 dose of lurasidone (n = 175; mean age 14.2 years; mean dose 33.6 mg/day) or placebo (n = 172; mean age 14.3 years). At week 6, treatment with lurasidone was associated with statistically significant improvement compared with placebo in CDRS-R total score (-21.0 versus-15.3; p < .0001; effect size 0.45). Lurasidone also was associated with statistically significant improvement in the Clinical Global Impression Bipolar Severity depression score (key secondary measure) and in measures of anxiety, quality of life, and global functioning. Study completion rates were 92.0% in the lurasidone group and 89.7% in the placebo group; discontinuation rates due to adverse events were the same for the 2 groups (1.7%). The 2 most common adverse events on lurasidone were nausea and somnolence. Treatment with lurasidone was associated with few effects on weight and metabolic parameters.Conclusion: In this placebo-controlled study, mono therapy with lurasidone, in the dose range of 20 to 80 mg/day, significantly decreased depressive symptoms in children and adolescents with bipolar depression. Lurasidone was well tolerated, with minimal effects on weight and metabolic parameters.