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功能评估简短测试(FAST):接受抗抑郁治疗的重度抑郁症患者的临床有意义反应阈值。

The Functioning Assessment Short Test (FAST): Clinically meaningful response threshold in patients with major depressive disorder receiving antidepressant treatment.

机构信息

H. Lundbeck A/S, Valby, Denmark.

H. Lundbeck A/S, Valby, Denmark.

出版信息

J Affect Disord. 2024 Oct 15;363:634-642. doi: 10.1016/j.jad.2024.07.018. Epub 2024 Jul 15.

Abstract

BACKGROUND

Functional impairment is common in patients with major depressive disorder (MDD). The Functioning Assessment Short Test (FAST) provides a detailed clinician-rated assessment of functioning across multiple aspects of daily life. This study aimed to establish clinically relevant response thresholds for the FAST in patients with MDD receiving antidepressant treatment.

METHODS

Data were derived from three 8-week clinical trials of antidepressant therapy in patients with MDD that included assessment of functioning using the FAST as a pre-specified endpoint. The minimal clinically important difference (MCID) and threshold for response in terms of change in FAST total score were determined using anchor-based methods.

RESULTS

After 8 weeks of antidepressant treatment, the mean reduction in FAST total score in patients considered clinically minimally improved (Clinical Global Impression-Improvement [CGI-I] score of 3) was 7-9 points (20 % reduction). The threshold for functional response (reduction in FAST total score from baseline in patients with a CGI-I score of ≤2 at week 8) was 16-19 points (50 % reduction). The threshold for functional response was higher in patients with MDD and comorbid generalized anxiety disorder than in those with MDD alone (mean reduction in FAST total score at 8 weeks: 26 points [63 %]).

LIMITATIONS

Short-term studies.

CONCLUSIONS

These results provide further validation of the FAST for assessing functioning in patients with MDD. In patients with MDD, the suggested MCID for FAST total score is 7-9 points and the proposed threshold for response is a reduction from baseline of approximately 50 %.

摘要

背景

在患有重度抑郁症(MDD)的患者中,功能障碍很常见。功能评估简短测试(FAST)提供了对日常生活多个方面的功能进行详细的临床评估。本研究旨在为接受抗抑郁治疗的 MDD 患者建立 FAST 的临床相关反应阈值。

方法

数据来自三项为期 8 周的抗抑郁治疗临床试验,这些试验包括使用 FAST 作为预先指定的终点评估功能。使用基于锚定的方法确定 FAST 总分变化的最小临床重要差异(MCID)和反应阈值。

结果

在 8 周的抗抑郁治疗后,被认为临床轻度改善的患者(临床总体印象改善量表 [CGI-I] 评分为 3)的 FAST 总分平均降低 7-9 分(20%的降低)。功能反应的阈值(8 周时 CGI-I 评分≤2 的患者 FAST 总分从基线的降低)为 16-19 分(50%的降低)。与仅患有 MDD 的患者相比,患有 MDD 和共患广泛性焦虑症的患者的功能反应阈值更高(8 周时 FAST 总分的平均降低:26 分[63%])。

局限性

短期研究。

结论

这些结果进一步验证了 FAST 用于评估 MDD 患者的功能。在 MDD 患者中,FAST 总分的建议 MCID 为 7-9 分,建议的反应阈值为基线降低约 50%。

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