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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

Authors Kuga A, Otsubo T, Tsuji T, Hayashi S, Imagawa H, Fujikoshi S, Escobar R

Received 21 November 2018

Accepted for publication 25 February 2019

Published 5 April 2019 Volume 2019:15 Pages 809—817


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Roger Pinder

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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