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      Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials

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          Abstract

          Aims

          The aim of this study was to assess how quickly and effectively duloxetine improves energy compared with placebo in patients with major depressive disorder (MDD).

          Methods

          Data from 10 randomised, double-blind, placebo-controlled clinical trials examining duloxetine (40–60 mg/day) vs. placebo in patients diagnosed with MDD were analysed. Change from baseline at Week 1 through Week 8 in Hamilton Depression Rating Scale (HAM-D) retardation subscale score (Item 1 – depressed mood, Item 7 – work and activities, Item 8 – retardation and Item 14 – genital symptoms) was assessed with mixed model repeated measures analysis. Positive predictive values and negative predictive values were calculated for predictor analysis.

          Results

          Patients treated with duloxetine ( N = 1522) experienced statistically significantly (p   0.05) greater reductions in HAM-D retardation subscale scores vs. placebo ( N = 1180) starting at Week 1 throughout Week 8 of treatment. Of the patients with early energy improvement (≥ 20% reduction in HAM-D retardation subscale scores) at Week 1, 48% achieved remission (HAM-D total score ≤ 7) at Week 8; 48% and 46% of patients who experienced early energy improvement at Weeks 2 and 4, respectively, achieved remission at Week 8.

          Discussion

          We demonstrated that treatment with duloxetine, quickly and with increasing magnitude over treatment time, improves low energy symptoms. As early as 1 week after starting treatment with duloxetine, improvement of low energy may serve as a predictor of remission at end-point.

          Conclusions

          Treatment with duloxetine improves energy in patients with MDD and early response in retardation may serve as a modest predictor of remission at end-point.

          Clinical trials registration

          ClinicalTrials.gov. Study Identifiers: NCT00036335; NCT00073411; NCT00406848 and NCT00536471. Studies HMAQa, HMAQb, HMATa, HMATb, HMBHa and HMBHb predate the registration requirement.

          Data posting

          ClinicalTrials.gov. Study Identifiers: NCT00406848; NCT00536471.

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          Most cited references30

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          Core symptoms of major depressive disorder: relevance to diagnosis and treatment

          The construct of major depressive disorder makes no etiological assumptions about populations with diverse symptom clusters. “Depressed mood” and “loss of interest or pleasure in nearly all activities” are core features of a major depressive episode, though a strong case can be made to pay increasing attention to symptoms of fatigue, sleep disturbance, anxiety, and neurocognitive and sexual dysfunction in the diagnosis and evaluation of treatment outcome. Mood, guilt, work, and interest, as well as psychic anxiety, are consistently identified across validated subscales of the Hamilton Depression Rating Scale as prevalent and sensitive to change with existing treatments. A major limitation of these antidepressant therapies is their narrow spectrum of action. While the core “mood and interest” symptoms have been the main focus of attention, the associated symptoms listed above are often unaffected or exacerbated by current treatments. Careful clinical evaluation should address all of these dimensions, recognizing that improvement may occur sooner in some symptoms (eg, mood) compared with others (eg, sleep disturbance).
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            Antidepressants and brain monoaminergic systems: a dimensional approach to understanding their behavioural effects in depression and anxiety disorders.

            There is extensive comorbidity between depression and anxiety disorders. Dimensional psychiatric and psychometric approaches have suggested that dysregulation of a limited number of behavioural dimensions that cut across diagnostic categories can account for both the shared and unique symptoms of depression and anxiety disorders. Such an approach recognizes that anxiety, the emotional response to stress, is a key element of depression as well as the defining feature of anxiety disorders, and many antidepressants appear to be effective in the treatment of anxiety disorders as well as depression. Therefore, the pharmacological actions of these drugs must account for their efficacy in both. Brain noradrenergic and serotonergic systems, and perhaps to a more limited extent the dopaminergic system, regulate or modulate many of the same behavioural dimensions (e.g. negative or positive affect) that are affected in depression and anxiety disorders, and that are ameliorated by drug treatment. Whereas much recent research has focused on the regulatory effects of antidepressants on synaptic function and cellular proteins, less emphasis has been placed on monoaminergic regulation at a more global systemic level, or how such systemic alterations in monoaminergic function might alleviate the behavioural, cognitive, emotional and physiological manifestations of depression and anxiety disorders. In this review, we discuss how chronic antidepressant treatment might regulate the tonic activity and/or phasic reactivity of brain monoaminergic systems to account for their ability to effectively modify the behavioural dimensions underlying improvement in both depression and anxiety disorders.
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              Residual symptoms in depressed outpatients who respond by 50% but do not remit to antidepressant medication.

              Little is known about the quantity or quality of residual depressive symptoms in patients with major depressive disorder (MDD) who have responded but not remitted with antidepressant treatment. This report describes the residual symptom domains and individual depressive symptoms in a large representative sample of outpatients with nonpsychotic MDD who responded without remitting after up to 12 weeks of citalopram treatment in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Response was defined as 50% or greater reduction in baseline 16-item Quick Inventory of Depressive Symptomatology--Self-Report (QIDS-SR₁₆) by treatment exit, and remission as a final QIDS-SR₁₆ of less than 6. Residual symptom domains and individual symptoms were based on the QIDS-SR₁₆ and classified as either persisting from baseline or emerging during treatment. Most responders who did not remit endorsed approximately 5 residual symptom domains and 6 to 7 residual depressive symptoms. The most common domains were insomnia (94.6%), sad mood (70.8%), and decreased concentration (69.6%). The most common individual symptoms were midnocturnal insomnia (79.0%), sad mood (70.8%), and decreased concentration/decision making (69.6%). The most common treatment-emergent symptoms were midnocturnal insomnia (51.4%) and decreased general interest (40.0%). The most common persistent symptoms were midnocturnal insomnia (81.6%), sad mood (70.8%), and decreased concentration/decision making (70.6%). Suicidal ideation was the least common treatment-emergent symptom (0.7%) and the least common persistent residual symptom (17.1%). These findings suggest that depressed outpatients who respond by 50% without remitting to citalopram treatment have a broad range of residual symptoms. Individualized treatments are warranted to specifically address each patient's residual depressive symptoms.
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                Author and article information

                Journal
                Int J Clin Pract
                Int. J. Clin. Pract
                ijcp
                International Journal of Clinical Practice
                John Wiley & Sons, Ltd (Chichester, UK )
                1368-5031
                1742-1241
                October 2015
                16 May 2015
                : 69
                : 10
                : 1139-1148
                Affiliations
                [1 ]Medical Science, Eli Lilly Japan K.K. Hyogo, Japan
                [2 ]Department of Neuropsychiatry, Kansai Medical University Osaka, Japan
                [3 ]Statistical Science, Eli Lilly Japan K.K. Hyogo, Japan
                [4 ]Neuroscience, Eli Lilly and Company Indianapolis, IN, USA
                [5 ]Global Statistical Sciences, Eli Lilly and Company Bad Homburg, Germany
                Author notes
                Correspondence to: , Hirofumi Tokuoka, Lilly Research Laboratories Japan, Eli Lilly Japan K.K., 6510086, Kobe, Japan, Tel.: + 81 3 5574 9234, Fax: +81 3 5574 9979, Email: tokuoka_hirofumi@ 123456lilly.com

                DisclosuresDrs Eiji Harada, Shinji Fujikoshi and Hirofumi Tokuoka are employees of Eli Lilly Japan K.K., and may own Eli Lilly stock. Dr Madelaine M. Wohlreich is an employee of Eli Lilly and Company, and may own Eli Lilly stock. Ms. Lovisa Berggren is contractor working for Eli Lilly and Company. Dr Masaki Kato has received grants from SENSHIN Medical Research Foundation and Grant-in-Aid for Scientific Research (KAKENHI), and consultant fees, and/or speaker’s honoraria from Otsuka, Dainippon-Sumitomo Pharma, Glaxo Smith Klein, Meiji-Seika Pharma, MSD, Ono Pharmaceutical, Eli Lilly and Company, Pfizer, and Shionogi & CO.LTD.

                Article
                10.1111/ijcp.12658
                4682452
                25980552
                f29a7c22-1b7a-4949-8670-19b6ee288689
                © 2015 Eli Lilly Japan K.K. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

                History
                : September 2014
                : March 2015
                Categories
                Psychiatry

                Medicine
                Medicine

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