Leucht Stefan, Fennema Hein, Engel Rolf R, Kaspers-Janssen Marion, Lepping Peter, Szegedi Armin
Department of Psychiatry and Psychotherapy, Technische Universität München, Klinikum rechts der Isar, Ismaningerstr 22, 81675 München, Germany.
Janssen Pharmaceutical, Belgium.
J Affect Disord. 2017 Mar 1;210:287-293. doi: 10.1016/j.jad.2016.12.041. Epub 2016 Dec 29.
Little is known about the clinical relevance of the Montgomery Asberg Depression Rating Scale (MADRS) total scores. It is unclear how total scores translate into clinical severity, or how commonly used measures for response (reduction from baseline of ≥50% in the total score) translate into clinical relevance. Moreover, MADRS based definitions of remission vary.
We therefore compared: a/ the MADRS total score with the Clinical Global Impression - Severity Score (CGI-S) b/ the percentage and absolute change in the MADRS total scores with Clinical Global Impression - Improvement (CGI-I); c/ the absolute and percentage change in the MADRS total scores with CGI-S absolute change. The method used was equipercentile linking of MADRS and CGI ratings from 22 drug trials in patients with Major Depressive Disorder (MDD) (n=3288).
Our results confirm the validity of the commonly used measures for response in MDD trials: a CGI-I score of 2 ('much improved') corresponded to a percentage MADRS reduction from baseline of 48-57%, and a CGI-I score of 1 ('very much improved') to a reduction of 80-84%. If a state of almost complete absence of symptoms were required for a definition of remission, a MADRS total score would be <8, because such scores corresponded to a CGI-S score of 2 ('borderline mentally ill').
Although our analysis is based on a large number of patients, the original trials were not specifically designed to examine our research question.
The results might contribute to a better understanding and improved interpretation of clinical trial results in MDD.
蒙哥马利-阿斯伯格抑郁评定量表（MADRS）总分的临床相关性鲜为人知。目前尚不清楚总分如何转化为临床严重程度，或者常用的反应测量指标（总分较基线降低≥50%）如何转化为临床相关性。此外，基于MADRS的缓解定义各不相同。
因此，我们比较了：a/MADRS总分与临床总体印象-严重程度量表（CGI-S）；b/MADRS总分的百分比变化和绝对变化与临床总体印象-改善量表（CGI-I）；c/MADRS总分的绝对变化和百分比变化与CGI-S绝对变化。所采用的方法是对22项针对重度抑郁症（MDD）患者的药物试验（n=3288）中的MADRS和CGI评分进行等百分位链接。
我们的结果证实了MDD试验中常用反应测量指标的有效性：CGI-I评分为2（‘明显改善’）对应MADRS总分较基线降低48 - 57%，CGI-I评分为1（‘非常明显改善’）对应降低80 - 84%。如果缓解定义要求几乎完全没有症状，MADRS总分应<8，因为这样的分数对应CGI-S评分为2（‘边缘性精神疾病’）。
尽管我们的分析基于大量患者，但原始试验并非专门设计用于检验我们的研究问题。
这些结果可能有助于更好地理解和解释MDD临床试验结果。
