背景:先前有报道称,蒙哥马利-奥斯贝格抑郁量表(MADRS)快感缺失因子评分与评估重度抑郁障碍(MDD)患者功能的量表相关。
方法:这是对一个数据库的分析,包括5个长期,先前对照试验的扩展研究,评估了开放标签的效果,成人MDD患者使用沃替西汀维持治疗(1年内5-20mg/天)。我们评估了MADRS快感缺失因子评分的变化与严重程度临床总体印象(CGI-S)变化的相关性,Sheehan残疾量表(SDS),和SF-36。使用CGI-S作为锚点确定MADRS快感缺乏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维持治疗的1年中持续改善(第12个月时从基线的-6.2±0.2的平均±SE变化)。MADRS快感缺失因子得分的变化与CGI-S的变化相关(第4周,r=0.71),SDS(第24周r=0.60)和SF-36结构域(第24周r=-0.19至-0.61)得分。使用CGI-S上的1级改进作为锚,与基线相比,MADRS快感缺失因子得分的MCIC在第4周为-4.6,在第24周为-5.5,在第52周为-5.3.
结论:MADRS量表,也不是主要研究,是专门用来评估快感缺乏的。
结论:这些开放标签数据表明,接受沃替西汀治疗的患者在维持治疗1年后,快感缺失继续表现出临床相关的改善。快感缺乏症的改善与功能和生活质量的改善有关。
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.
CONCLUSIONS: 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.