Analysis of HAM-D scores and working ability in an observational study of Japanese patients with major depressive disorder and painful physical symptoms treated with duloxetine or SSRI monotherapy

Atsushi Kuga,1,* Tempei Otsubo,2,* Toshinaga Tsuji,3 Shinji Hayashi,3 Hideyuki Imagawa,1 Shinji Fujikoshi,1 Rodrigo Escobar4 1Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan; 2Department of Psychiatry, Tokyo Women’s Medical University, Medical Center East, Tokyo, Japan...

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Autores principales:	Kuga A, Otsubo T, Tsuji T, Hayashi S, Imagawa H, Fujikoshi S, Escobar R
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	major depressive disorder painful physical symptoms HAM-D working ability duloxetine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/6b44c57f580c4bd19320fce47f0e7f68
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spelling	oai:doaj.org-article:6b44c57f580c4bd19320fce47f0e7f682021-12-02T09:58:13ZAnalysis of HAM-D scores and working ability in an observational study of Japanese patients with major depressive disorder and painful physical symptoms treated with duloxetine or SSRI monotherapy1178-2021https://doaj.org/article/6b44c57f580c4bd19320fce47f0e7f682019-04-01T00:00:00Zhttps://www.dovepress.com/analysis-of-ham-d-scores-and-working-ability-in-an-observational-study-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Atsushi Kuga,1,* Tempei Otsubo,2,* Toshinaga Tsuji,3 Shinji Hayashi,3 Hideyuki Imagawa,1 Shinji Fujikoshi,1 Rodrigo Escobar4 1Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan; 2Department of Psychiatry, Tokyo Women’s Medical University, Medical Center East, Tokyo, Japan; 3Medical Affairs Department, Shionogi & Co., Ltd., Osaka, Japan; 4Bio-Medicines Global Team, Eli Lilly and Company, Madrid, Spain *These authors contributed equally to this work Objective: To investigate the relationship between Hamilton Depression Rating Scale (HAM-D) score and psychiatrists’ judgment of working ability in patients with major depressive disorder (MDD) and painful physical symptoms.Methods: This was a prospective, observational, 12-week study in patients who received duloxetine or a selective serotonin reuptake inhibitor. Patients were ≥20 years old, resided in Japan, and had at least moderate depression (Quick Inventory of Depressive Symptomatology ≥16) and at least moderate painful physical symptoms (Brief Pain Inventory-Short Form average pain ≥3). The main outcome in this post-hoc analysis was the HAM-D17 cutoff best corresponding with patients’ working ability according to the investigator’s judgment. Area under the receiver-operator curve was used to determine the time point with the strongest relationship between HAM-D17 and working ability. The optimal HAM-D17 cutoff was determined based on the maximum of sensitivity (true positive rate) minus ([1 minus specificity] [true negative rate]). For the evaluation of binary data, a mixed effects model with repeated measures analysis was used.Results: For the estimation of the HAM-D17 cutoff, the area under the receiver-operator curve was maximal at 12 weeks, when a HAM-D17 score of 6 resulted in the best correspondence with working ability in the combined study population. At 12 weeks, a HAM-D17 score of 6 also resulted in the maximum predictive ability in each of the two treatment groups separately. For predicted working ability at 12 weeks, 52.7% of duloxetine-treated patients achieved the HAM-D17 cutoff of ≤6, whereas 48.5% of SSRIs-treated patients achieved HAM-D17 ≤6 (P=0.477).Conclusion: In this study of patients with major depressive disorder and painful physical symptoms, a HAM-D17 score ≤6 corresponded best with patients’ working ability. This finding is consistent with previous studies showing that a HAM-D17 cutoff of ≤7 may overestimate functional recovery from MDD. Keywords: functional recovery, reinstatement, remissionKuga AOtsubo TTsuji THayashi SImagawa HFujikoshi SEscobar RDove Medical Pressarticlemajor depressive disorderpainful physical symptomsHAM-Dworking abilityduloxetineNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 15, Pp 809-817 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	major depressive disorder painful physical symptoms HAM-D working ability duloxetine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	major depressive disorder painful physical symptoms HAM-D working ability duloxetine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Kuga A Otsubo T Tsuji T Hayashi S Imagawa H Fujikoshi S Escobar R Analysis of HAM-D scores and working ability in an observational study of Japanese patients with major depressive disorder and painful physical symptoms treated with duloxetine or SSRI monotherapy
description	Atsushi Kuga,1,* Tempei Otsubo,2,* Toshinaga Tsuji,3 Shinji Hayashi,3 Hideyuki Imagawa,1 Shinji Fujikoshi,1 Rodrigo Escobar4 1Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan; 2Department of Psychiatry, Tokyo Women’s Medical University, Medical Center East, Tokyo, Japan; 3Medical Affairs Department, Shionogi & Co., Ltd., Osaka, Japan; 4Bio-Medicines Global Team, Eli Lilly and Company, Madrid, Spain *These authors contributed equally to this work Objective: To investigate the relationship between Hamilton Depression Rating Scale (HAM-D) score and psychiatrists’ judgment of working ability in patients with major depressive disorder (MDD) and painful physical symptoms.Methods: This was a prospective, observational, 12-week study in patients who received duloxetine or a selective serotonin reuptake inhibitor. Patients were ≥20 years old, resided in Japan, and had at least moderate depression (Quick Inventory of Depressive Symptomatology ≥16) and at least moderate painful physical symptoms (Brief Pain Inventory-Short Form average pain ≥3). The main outcome in this post-hoc analysis was the HAM-D17 cutoff best corresponding with patients’ working ability according to the investigator’s judgment. Area under the receiver-operator curve was used to determine the time point with the strongest relationship between HAM-D17 and working ability. The optimal HAM-D17 cutoff was determined based on the maximum of sensitivity (true positive rate) minus ([1 minus specificity] [true negative rate]). For the evaluation of binary data, a mixed effects model with repeated measures analysis was used.Results: For the estimation of the HAM-D17 cutoff, the area under the receiver-operator curve was maximal at 12 weeks, when a HAM-D17 score of 6 resulted in the best correspondence with working ability in the combined study population. At 12 weeks, a HAM-D17 score of 6 also resulted in the maximum predictive ability in each of the two treatment groups separately. For predicted working ability at 12 weeks, 52.7% of duloxetine-treated patients achieved the HAM-D17 cutoff of ≤6, whereas 48.5% of SSRIs-treated patients achieved HAM-D17 ≤6 (P=0.477).Conclusion: In this study of patients with major depressive disorder and painful physical symptoms, a HAM-D17 score ≤6 corresponded best with patients’ working ability. This finding is consistent with previous studies showing that a HAM-D17 cutoff of ≤7 may overestimate functional recovery from MDD. Keywords: functional recovery, reinstatement, remission
format	article
author	Kuga A Otsubo T Tsuji T Hayashi S Imagawa H Fujikoshi S Escobar R
author_facet	Kuga A Otsubo T Tsuji T Hayashi S Imagawa H Fujikoshi S Escobar R
author_sort	Kuga A
title	Analysis of HAM-D scores and working ability in an observational study of Japanese patients with major depressive disorder and painful physical symptoms treated with duloxetine or SSRI monotherapy
title_short	Analysis of HAM-D scores and working ability in an observational study of Japanese patients with major depressive disorder and painful physical symptoms treated with duloxetine or SSRI monotherapy
title_full	Analysis of HAM-D scores and working ability in an observational study of Japanese patients with major depressive disorder and painful physical symptoms treated with duloxetine or SSRI monotherapy
title_fullStr	Analysis of HAM-D scores and working ability in an observational study of Japanese patients with major depressive disorder and painful physical symptoms treated with duloxetine or SSRI monotherapy
title_full_unstemmed	Analysis of HAM-D scores and working ability in an observational study of Japanese patients with major depressive disorder and painful physical symptoms treated with duloxetine or SSRI monotherapy
title_sort	analysis of ham-d scores and working ability in an observational study of japanese patients with major depressive disorder and painful physical symptoms treated with duloxetine or ssri monotherapy
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/6b44c57f580c4bd19320fce47f0e7f68
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Analysis of HAM-D scores and working ability in an observational study of Japanese patients with major depressive disorder and painful physical symptoms treated with duloxetine or SSRI monotherapy

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