Changes in energy during treatment of depression: an analysis of duloxetine in double‐blind placebo‐controlled trials. Issue 10 (16th May 2015)

• Record Type: Journal Article
• Authors: Harada, E.; Kato, M.; Fujikoshi, S.; Wohlreich, M. M.; Berggren, L.; Tokuoka, H.
• Is Part Of: International journal of clinical practice. Volume 69:Issue 10(2015)
• Page Start: 1139
• Page End: 1148
• Publication Date: 2015-05-16
• Subjects: Clinical medicine -- Periodicals; Medicine -- Periodicals; 610.5
• DOI: 10.1111/ijcp.12658
• Languages: English
• ISSNs: 1368-5031

Abstract

<abstract abstract-type="main" id="ijcp12658-abs-0001"> <title>Summary</title> <sec id="ijcp12658-sec-0001" sec-type="section"> <title>Aims</title> <p>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).</p> </sec> <sec id="ijcp12658-sec-0002" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="ijcp12658-sec-0003" sec-type="section"> <title>Results</title> <p>Patients treated with duloxetine (<italic>N</italic> = 1522) experienced statistically significantly (p<italic> </italic>≤<italic> </italic>0.05) greater reductions in HAM‐D retardation subscale scores vs. placebo (<italic>N</italic> = 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.</p> </sec> <sec id="ijcp12658-sec-0004" sec-type="section"> <title>Discussion</title> <p>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.</p> </sec> <sec id="ijcp12658-sec-0005" sec-type="section"> <title>Conclusions</title> <p>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.</p> </sec> <sec id="ijcp12658-sec-0105" sec-type="section"> <title>Clinical trials registration</title> <p>ClinicalTrials.gov. Study Identifiers: NCT00036335; NCT00073411; NCT00406848 and NCT00536471. Studies HMAQa, HMAQb, HMATa, HMATb, HMBHa and HMBHb predate the registration requirement.</p> </sec> <sec id="ijcp12658-sec-0106" sec-type="section"> <title>Data posting</title> <p>ClinicalTrials.gov. Study Identifiers: NCT00406848; NCT00536471.</p> </sec> </abstract>