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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Main Authors: Kuga A, Otsubo T, Tsuji T, Hayashi S, Imagawa H, Fujikoshi S, Escobar R
Format: Article
Language:English
Published: Dove Medical Press 2019-04-01
Series:Neuropsychiatric Disease and Treatment
Subjects:
Online Access:https://www.dovepress.com/analysis-of-ham-d-scores-and-working-ability-in-an-observational-study-peer-reviewed-article-NDT
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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
collection DOAJ
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
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spelling doaj.art-6b44c57f580c4bd19320fce47f0e7f682022-12-21T23:37:05ZengDove Medical PressNeuropsychiatric Disease and Treatment1178-20212019-04-01Volume 1580981744937Analysis 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 monotherapyKuga AOtsubo TTsuji THayashi SImagawa HFujikoshi SEscobar RAtsushi 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, remissionhttps://www.dovepress.com/analysis-of-ham-d-scores-and-working-ability-in-an-observational-study-peer-reviewed-article-NDTmajor depressive disorderpainful physical symptomsHAM-Dworking abilityduloxetine
spellingShingle 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
Neuropsychiatric Disease and Treatment
major depressive disorder
painful physical symptoms
HAM-D
working ability
duloxetine
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_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_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_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
topic major depressive disorder
painful physical symptoms
HAM-D
working ability
duloxetine
url https://www.dovepress.com/analysis-of-ham-d-scores-and-working-ability-in-an-observational-study-peer-reviewed-article-NDT
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