Predicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine

Hirofumi Tokuoka,1 Makoto Nishihara,2 Shinji Fujikoshi,3 Aki Yoshikawa,4 Atsushi Kuga1 1Bio-Medicine, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, 2Multidisciplinary Pain Center, Aichi Medical University, Nagakute, Aichi, 3Statistical Science, 4Scientific Communications, Medicines...

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Autores principales:	Tokuoka H, Nishihara M, Fujikoshi S, Yoshikawa A, Kuga A
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	Brief Pain Inventory Montgomery–Asberg Depression Rating Scale pain predictor remission Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/c7f93ed583e34455b232aa2336b95e85
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spelling	oai:doaj.org-article:c7f93ed583e34455b232aa2336b95e852021-12-02T02:00:24ZPredicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine1178-2021https://doaj.org/article/c7f93ed583e34455b232aa2336b95e852017-09-01T00:00:00Zhttps://www.dovepress.com/predicting-treatment-outcomes-of-major-depressive-disorder-by-early-im-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Hirofumi Tokuoka,1 Makoto Nishihara,2 Shinji Fujikoshi,3 Aki Yoshikawa,4 Atsushi Kuga1 1Bio-Medicine, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, 2Multidisciplinary Pain Center, Aichi Medical University, Nagakute, Aichi, 3Statistical Science, 4Scientific Communications, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan Objective: We determined if early improvement in painful physical symptoms (PPS) can be a predictor of remission in the treatment of major depressive disorder (MDD).Methods: We included randomized, double-blind, parallel-group clinical trials of duloxetine (40–60 mg/day) versus placebo for the acute treatment of MDD with associated PPS. Only those studies using the Montgomery–Åsberg Depression Rating Scale (MADRS) and the Brief Pain Inventory – Short Form (BPI-SF) were included. Three studies met all criteria and included male or female outpatients aged ≥18 years who met the diagnostic criteria for MDD, had a MADRS total score ≥20, and had at least moderate pain (BPI-SF average pain score ≥3). Positive predictive values (PPVs) and negative predictive values (NPVs) of early improvement in PPS for remission were analyzed. PPVs were the proportion of patients with remission (MADRS total score ≤10) at week 8 out of patients who experienced early improvement in BPI-SF average pain score (≥30% decrease from baseline at week 1, 2, or 4). NPVs were the proportion of patients without remission (MADRS total score >10) at week 8 out of patients who did not experience early improvement in PPS.Results: Data from 1,320 patients were analyzed (duloxetine N=641 and placebo N=679). The overall remission (MADRS total score ≤10 at week 8) rate for the duloxetine group was significantly higher than the placebo group (38.5% vs 21.8%; P<0.0001). For both treatment groups, PPVs of early improvement in BPI-SF (30% improvement from baseline) were higher than the overall remission rate for all weeks examined (weeks 1, 2, and 4); in general, NPVs of early improvement in BPI-SF for nonremission were higher than the overall nonremission rate.Conclusion: Early improvement in PPS can be a useful clinical indicator of subsequent treatment outcome for MDD patients with associated PPS. Keywords: Brief Pain Inventory, Montgomery–Åsberg Depression Rating Scale, pain, predictor, remissionTokuoka HNishihara MFujikoshi SYoshikawa AKuga ADove Medical PressarticleBrief Pain InventoryMontgomery–Asberg Depression Rating ScalepainpredictorremissionNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 13, Pp 2457-2467 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Brief Pain Inventory Montgomery–Asberg Depression Rating Scale pain predictor remission Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Brief Pain Inventory Montgomery–Asberg Depression Rating Scale pain predictor remission Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Tokuoka H Nishihara M Fujikoshi S Yoshikawa A Kuga A Predicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine
description	Hirofumi Tokuoka,1 Makoto Nishihara,2 Shinji Fujikoshi,3 Aki Yoshikawa,4 Atsushi Kuga1 1Bio-Medicine, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, 2Multidisciplinary Pain Center, Aichi Medical University, Nagakute, Aichi, 3Statistical Science, 4Scientific Communications, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan Objective: We determined if early improvement in painful physical symptoms (PPS) can be a predictor of remission in the treatment of major depressive disorder (MDD).Methods: We included randomized, double-blind, parallel-group clinical trials of duloxetine (40–60 mg/day) versus placebo for the acute treatment of MDD with associated PPS. Only those studies using the Montgomery–Åsberg Depression Rating Scale (MADRS) and the Brief Pain Inventory – Short Form (BPI-SF) were included. Three studies met all criteria and included male or female outpatients aged ≥18 years who met the diagnostic criteria for MDD, had a MADRS total score ≥20, and had at least moderate pain (BPI-SF average pain score ≥3). Positive predictive values (PPVs) and negative predictive values (NPVs) of early improvement in PPS for remission were analyzed. PPVs were the proportion of patients with remission (MADRS total score ≤10) at week 8 out of patients who experienced early improvement in BPI-SF average pain score (≥30% decrease from baseline at week 1, 2, or 4). NPVs were the proportion of patients without remission (MADRS total score >10) at week 8 out of patients who did not experience early improvement in PPS.Results: Data from 1,320 patients were analyzed (duloxetine N=641 and placebo N=679). The overall remission (MADRS total score ≤10 at week 8) rate for the duloxetine group was significantly higher than the placebo group (38.5% vs 21.8%; P<0.0001). For both treatment groups, PPVs of early improvement in BPI-SF (30% improvement from baseline) were higher than the overall remission rate for all weeks examined (weeks 1, 2, and 4); in general, NPVs of early improvement in BPI-SF for nonremission were higher than the overall nonremission rate.Conclusion: Early improvement in PPS can be a useful clinical indicator of subsequent treatment outcome for MDD patients with associated PPS. Keywords: Brief Pain Inventory, Montgomery–Åsberg Depression Rating Scale, pain, predictor, remission
format	article
author	Tokuoka H Nishihara M Fujikoshi S Yoshikawa A Kuga A
author_facet	Tokuoka H Nishihara M Fujikoshi S Yoshikawa A Kuga A
author_sort	Tokuoka H
title	Predicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine
title_short	Predicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine
title_full	Predicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine
title_fullStr	Predicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine
title_full_unstemmed	Predicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine
title_sort	predicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/c7f93ed583e34455b232aa2336b95e85
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Predicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine

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