Harada E, Kato M, Fujikoshi S, Wohlreich M M, Berggren L, Tokuoka H
Medical Science, Eli Lilly Japan K.K., Hyogo, Japan.
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.
Int J Clin Pract. 2015 Oct;69(10):1139-48. doi: 10.1111/ijcp.12658. Epub 2015 May 16.
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).
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.
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.
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.
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.
ClinicalTrials.gov. Study Identifiers: NCT00036335; NCT00073411; NCT00406848 and NCT00536471. Studies HMAQa, HMAQb, HMATa, HMATb, HMBHa and HMBHb predate the registration requirement.
ClinicalTrials.gov. Study Identifiers: NCT00406848; NCT00536471.
本研究旨在评估与安慰剂相比，度洛西汀在改善重度抑郁症（MDD）患者精力方面的速度和效果。
分析了10项随机、双盲、安慰剂对照临床试验的数据，这些试验比较了度洛西汀（40 - 60毫克/天）与安慰剂在诊断为MDD的患者中的疗效。采用混合模型重复测量分析评估从第1周到第8周汉密尔顿抑郁量表（HAM-D）迟缓分量表评分（项目1 - 抑郁情绪、项目7 - 工作和活动、项目8 - 迟缓以及项目14 - 生殖系统症状）相对于基线的变化。计算预测分析的阳性预测值和阴性预测值。
在治疗的第1周开始至第8周，接受度洛西汀治疗的患者（N = 1522）与接受安慰剂治疗的患者（N = 1180）相比，HAM-D迟缓分量表评分在统计学上有显著更大幅度的降低（p≤0.05）。在第1周时HAM-D迟缓分量表评分有早期精力改善（降低≥20%）的患者中，48%在第8周达到缓解（HAM-D总分≤7）；在第2周和第4周有早期精力改善的患者中，分别有48%和46%在第8周达到缓解。
我们证明，度洛西汀治疗能迅速改善低精力症状，且随着治疗时间延长改善程度增加。早在开始度洛西汀治疗1周后，低精力的改善可作为终点缓解的预测指标。
度洛西汀治疗可改善MDD患者的精力，迟缓方面的早期反应可作为终点缓解的适度预测指标。
ClinicalTrials.gov。研究标识符：NCT00036335；NCT00073411；NCT00406848和NCT00536471。研究HMAQa、HMAQb、HMATa、HMATb、HMBHa和HMBHb早于注册要求。
ClinicalTrials.gov。研究标识符：NCT00406848；NCT00536471。
