Zuranolone治疗14天对产后抑郁症患者HAMD-17量表评分的改善:来自SKYLARK研究的结果[j]

K. Deligiannidis, Amy Bullock, M. Kotecha, Sigui Li, B. Maximos, Theresa Vera
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引用次数: 0

摘要

产后抑郁症(PPD)是一种严重的围产期并发症。SKYLARK(3期,随机,双盲,安慰剂对照试验[NCT04442503])评估了zuranolone(一种神经活性类固醇阳性变构调节剂,可调节突触和突触外GABA(A)受体)在成年PPD患者中的作用。主要终点是第15天HAMD-17总分的基线变化(CFB)。舒诺酮总体耐受良好。HAMD-17可以分为几个子量表,这些子量表对HAMD-17量表中的特定项目进行分组,测量抑郁症表现的不同方面。在这里,我们展示了来自SKYLARK的HAMD-17亚尺度数据。方法:年龄在18-45岁的重度PPD (HAMD 17总分≥26)患者按1:1的比例随机分为口服、每日一次、50mg的祖拉诺酮或安慰剂,疗程14天。次要终点是HAMD-17亚量表(核心抑郁、焦虑、Bech-6、Maier)评分的第15天CFB。对重复测量的子量表分别采用混合效应模型进行分析。已获得机构审查委员会的批准。结果:195例患者(曲那诺酮,98例;安慰剂,97例)被随机分配,接受研究药物,并有有效的基线和一个或多个基线后疗效评估。在第15天,接受为期14天的唑诺酮治疗的患者与安慰剂相比,在所有HAMD-17亚量表上都显示出名义上的显著改善(最小二乘平均[SE] CFB治疗差异:核心抑郁症,−5.9 [2.4],P= 0.0151;焦虑,−5.7 [2.3],P= 0.0123;Bech-6,−8.6 [3.0],P= 0.0040;Maier,−7.6 [2.6],P=.0041)。从第3天开始观察到所有亚量表的改善。结论:在SKYLARK试验中,祖拉诺酮与PPD患者抑郁和焦虑症状的快速改善相关,支持其作为PPD潜在的口服、速效治疗选择的发展。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Improvement in HAMD-17 Subscale Scores With 14-Day Treatment Course of Zuranolone in Postpartum Depression: Results From the SKYLARK Study [ID: 1372313]
INTRODUCTION: Postpartum depression (PPD) is a serious perinatal complication. SKYLARK (phase 3, randomized, double-blind, placebo-controlled trial [NCT04442503]) evaluated zuranolone, an investigational, neuroactive steroid positive allosteric modulator of both synaptic and extrasynaptic GABA(A) receptors, in adult patients with PPD. The primary endpoint, change from baseline (CFB) in HAMD-17 total score at day 15, was met. Zuranolone was generally well tolerated. The HAMD-17 can be divided into subscales that group specific items from the HAMD-17 scale that measure different aspects of depression presentation. Here, we present HAMD-17 subscale data from SKYLARK. METHODS: Patients aged 18–45 years with severe PPD (HAMD 17 total score ≥26) were randomized 1:1 to oral, once-daily zuranolone 50 mg or placebo for 14 days. The secondary endpoint was day 15 CFB in HAMD-17 subscale (Core Depression, Anxiety, Bech-6, Maier) scores. Subscales were analyzed separately by a mixed-effects model for repeated measures. Institutional review board approval was obtained. RESULTS: One hundred ninety-five patients (zuranolone, 98; placebo, 97) were randomized, received study drug, and had valid baseline and one or more post-baseline efficacy assessments. At day 15, patients receiving a 14-day treatment course of zuranolone showed nominally significant improvements across all HAMD-17 subscales versus placebo (least squares mean [SE] CFB treatment difference: Core Depression, −5.9 [2.4], P=.0151; Anxiety, −5.7 [2.3], P=.0123; Bech-6, −8.6 [3.0], P=.0040; Maier, −7.6 [2.6], P=.0041). Improvement in all subscales was observed starting at day 3. CONCLUSION: In SKYLARK, zuranolone was associated with rapid improvement in depressive and anxiety symptoms in patients with PPD across multiple domains, supporting its development as a potential oral, rapid-acting treatment option for PPD.
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