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MADRS 快感缺失因子评分的最小临床有意义变化:在伴有重性抑郁障碍的患者中,使用沃替西汀进行开放性研究的汇总分析。

Minimal clinically important change in the MADRS anhedonia factor score: A pooled analysis of open-label studies with vortioxetine in patients with major depressive disorder.

机构信息

University of Toronto, Toronto, ON, Canada; Brain and Cognition Discovery Foundation, Toronto, Canada.

H. Lundbeck A/S, Valby, Denmark.

出版信息

J Affect Disord. 2024 Oct 15;363:430-435. doi: 10.1016/j.jad.2024.07.070. Epub 2024 Jul 18.

DOI:10.1016/j.jad.2024.07.070
PMID:39032712
Abstract

BACKGROUND

It is previously reported that the Montgomery-Åsberg Depression Rating Scale (MADRS) anhedonia factor score is correlated with scales assessing function in patients with major depressive disorder (MDD).

METHODS

This was an analysis of a database including 5 long-term, extension studies of prior controlled trials, which evaluated the effects of open-label, maintenance treatment with vortioxetine (5-20 mg/day over 1-year) in adults with MDD. We assessed the association of changes in MADRS anhedonia factor scores with changes in the Clinical Global Impression of Severity (CGI-S), Sheehan Disability scale (SDS), and the SF-36. A minimal clinically important change (MCIC) for MADRS anhedonia factor scores was determined using the CGI-S as anchor.

RESULTS

In patients who had completed the prior controlled studies, MADRS anhedonia factor scores continued to improve over 1-year of maintenance treatment (mean ± SE change from baseline of -6.2 ± 0.2 at Month 12). Change in MADRS anhedonia factors score correlated with change in CGI-S (Week 4, r = 0.71), SDS (Week 24 r = 0.60) and SF-36 domains (Week 24 r = -0.19 to -0.61) scores. Using a 1 level improvement on CGI-S as anchor, the MCIC for MADRS anhedonia factor scores versus baseline were - 4.6 at Week 4, -5.5 at Week 24, and - 5.3 at Week 52.

LIMITATIONS

Neither the MADRS scale, nor the primary studies, were specifically designed to assess anhedonia.

CONCLUSIONS

These open-label data suggest that patients treated with vortioxetine continued to show clinically relevant improvements in their anhedonia over 1-year of maintenance therapy. Improvements in anhedonia correlated with improvements in measures of functioning and quality of life.

摘要

背景

先前有报道称,蒙哥马利-阿斯伯格抑郁评定量表(MADRS)的快感缺失因子评分与评估重度抑郁症(MDD)患者功能的量表相关。

方法

这是对包括五项先前对照试验的长期扩展研究数据库的分析,该分析评估了在 MDD 成人中,采用维拉唑汀(5-20mg/天,为期 1 年)进行开放标签、维持治疗的效果。我们评估了 MADRS 快感缺失因子评分的变化与临床总体印象严重程度(CGI-S)、Sheehan 残疾量表(SDS)和 SF-36 评分变化之间的相关性。使用 CGI-S 作为锚定物,确定 MADRS 快感缺失因子评分的最小临床重要变化(MCIC)。

结果

在完成先前对照研究的患者中,MADRS 快感缺失因子评分在 1 年的维持治疗中持续改善(从基线到第 12 个月的平均±SE 变化为-6.2±0.2)。MADRS 快感缺失因子评分的变化与 CGI-S(第 4 周,r=0.71)、SDS(第 24 周,r=0.60)和 SF-36 各领域评分(第 24 周 r=-0.19 至-0.61)的变化相关。使用 CGI-S 改善 1 级作为锚定物,与基线相比,MADRS 快感缺失因子评分的 MCIC 在第 4 周为-4.6,第 24 周为-5.5,第 52 周为-5.3。

局限性

无论是 MADRS 量表还是主要研究,都没有专门设计用于评估快感缺失。

结论

这些开放标签数据表明,接受维拉唑汀治疗的患者在 1 年的维持治疗中,快感缺失持续出现有临床意义的改善。快感缺失的改善与功能和生活质量测量的改善相关。

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