Abstract
Background:This study was designed to assess clinical and functional outcomes associated with switching to duloxetine treatment in patients with major depressive disorder (MDD) experiencing emotional and painful physical symptoms in their current episode.Methods:In this 8-week, multinational, multicentre, single-arm, open-label clinical trial, 242 MDD patients were switched to duloxetine 60 mg/day after selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) treatment. The primary analysis compared mean change from baseline in Brief Pain Inventory – Modified Short Form (BPI-SF) interference score between initial responders [≥ 50% reduction from baseline on the 17-item Hamilton Depression Rating Scale (HAMD17) Maier subscale] and initial non-responders after 4 weeks. Initial responders continued with duloxetine 60 mg/day. Initial non-responders received duloxetine 120 mg/day for the remaining 4 weeks. Depression, pain, anxiety and functional outcomes were also compared after 8 weeks.Results:BPI-SF interference decreased from baseline in initial responders (n = 108) and initial non-responders (n = 85) after 4 weeks of duloxetine treatment, with greater reductions in initial responders [BPI-SF mean difference in reduction: 1.01 (95% CI 0.42–1.61); p < 0.001]. Reductions in pain interference favouring initial responders were also apparent after 8 weeks [0.68 (95% CI: 0.03–1.33); p = 0.042]. Depression, pain, anxiety and function improved over 8 weeks across patient groups.Conclusions:Elements of core mood and pain are important residual symptoms following poor treatment response in MDD. Early improvement in these symptoms after switching to duloxetine indicated an increased chance of functional recovery.
Highlights
Major depressive disorder (MDD) is a chronic, disabling condition encompassing emotional, behavioural and physical symptoms that impact considerably upon patients [1,2]
This study explores the clinical course and functional outcomes of depressed patients, experiencing emotional and painful physical symptoms, who are switched to duloxetine treatment
Patient disposition Of the 242 patients enrolled in the 4-week acute therapy phase, 206 completed this initial treatment period
Summary
Major depressive disorder (MDD) is a chronic, disabling condition encompassing emotional, behavioural and physical symptoms that impact considerably upon patients [1,2]. Treatment for MDD aims to achieve complete remission of depressive symptoms and facilitate a return to normal functioning. Antidepressant medications, selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SNRIs), are widely used as first-line treatment options for MDD. Suboptimal response to antidepressant medication is common; up to 35% of patients treated in routine clinical practice have an inadequate response to first-line therapy [3] and only a third of patients may achieve clinical remission criteria [4,5]. Failure to achieve full remission of MDD is associated with a high risk of chronic symptoms and impaired quality of life [6,7,8] and physicians routinely switch antidepressant medications to improve clinical response [9]. Identifying key response attributes that enhance earlier recognition of patients who benefit from switching antidepressants would be of value
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