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Once-daily duloxetine 60 mg in the treatment of major depressive disorder: Multicenter, double-blind, randomized, paroxetine-controlled, non-inferiority trial in China, Korea, Taiwan and Brazil
Lee, Phil; Shu, Liang; Xu, Xiufeng; Wang, Chuan Yue; Lee, Min Soo; Liu, Chia-Yih; Hong, Jin Pyo; Ruschel, Sandra; Raskin, Joel; Colman, Samuel A.; Harrison, Gavan A.
关键词Asia duloxetine major depressive disorder MDD paroxetine
刊名PSYCHIATRY AND CLINICAL NEUROSCIENCES
2007-06-01
DOI10.1111/j.1440-1819.2007.01666.x
61期:3页:295-307
收录类别SCI ; SSCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Clinical Neurology ; Neurosciences ; Psychiatry
研究领域[WOS]Neurosciences & Neurology ; Psychiatry
关键词[WOS]SEROTONIN REUPTAKE INHIBITORS ; PAINFUL PHYSICAL SYMPTOMS ; PLACEBO-CONTROLLED TRIAL ; PRIMARY-CARE ; REMISSION RATES ; EFFICACY ; SAFETY ; ANTIDEPRESSANTS ; TOLERABILITY ; VENLAFAXINE
英文摘要

The aim of the present paper was to compare the efficacy and safety of duloxetine with paroxetine in the acute treatment of major depressive disorder (MDD). In a randomized, double-blind trial of 8 weeks active treatment, patients with non-psychotic MDD were randomized to duloxetine 60 mg (n = 238) or paroxetine 20 mg (n = 240) once daily. Efficacy was primarily measured on change in the 17-item Hamilton Rating Scale for Depression (HAMD(17)) using a non-inferiority test with a margin of 2.2. Secondary efficacy measures included the HAMD(17) subscales, Hamilton Rating Scale for Anxiety, Clinical Global Impressions-Severity, Patient Global Impressions-Improvement, Somatic Symptoms Inventory and Visual Analog Scales (VAS) for pain. Safety measures included treatment-emergent adverse events (TEAE), vital signs, weight, laboratory analyses and electrocardiograms. Non-inferiority of duloxetine to paroxetine was demonstrated because the upper bound of the confidence interval for mean difference in HAMD(17) change (0.71) was less than the non-inferiority margin. Secondary efficacy end-points did not differ significantly between treatments with the exception of VAS back pain, where the pooled mean was lower in the duloxetine group (17.1) compared with the paroxetine group (20.3, P = 0.048). No significant differences were observed in the number of early discontinuations and overall TEAE. However, significantly greater proportions of patients in the duloxetine group experienced nausea and palpitations. No clinically relevant changes in laboratory values, vital signs, weight or electrocardiograms were observed with either treatment. The present study verifies the utility of duloxetine as an efficacious and safe treatment for both emotional and physical symptoms of MDD in this predominantly Asian patient sample.

语种英语
WOS记录号WOS:000246151600013
引用统计
被引频次:36[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/65324
专题北京大学精神卫生研究所
作者单位1.Eli Lilly, Taipei, Taiwan
2.Chang Gung Mem Hosp Linkou, Tao Yuan, Taiwan
3.Peking Univ, Inst Mental Hlth, Beijing 100871, Peoples R China
4.Capital Med Univ, Beijing Anding Hosp, Beijing, Peoples R China
5.Kunming Med Coll, Affiliate Hosp 1, Kunming, Peoples R China
6.Korea Univ, Coll Med, Dept Psychiat, Seoul 136701, South Korea
7.Asan Med Ctr, Dept Psychiat, Seoul, South Korea
8.Eli Lilly Canada, Lilly Res Labs, Toronto, ON, Canada
9.Eli Lilly, Intercontinental Informat Sci, Sydney, NSW, Australia
推荐引用方式
GB/T 7714
Lee, Phil,Shu, Liang,Xu, Xiufeng,et al. Once-daily duloxetine 60 mg in the treatment of major depressive disorder: Multicenter, double-blind, randomized, paroxetine-controlled, non-inferiority trial in China, Korea, Taiwan and Brazil[J]. PSYCHIATRY AND CLINICAL NEUROSCIENCES,2007,61(3):295-307.
APA Lee, Phil.,Shu, Liang.,Xu, Xiufeng.,Wang, Chuan Yue.,Lee, Min Soo.,...&Harrison, Gavan A..(2007).Once-daily duloxetine 60 mg in the treatment of major depressive disorder: Multicenter, double-blind, randomized, paroxetine-controlled, non-inferiority trial in China, Korea, Taiwan and Brazil.PSYCHIATRY AND CLINICAL NEUROSCIENCES,61(3),295-307.
MLA Lee, Phil,et al."Once-daily duloxetine 60 mg in the treatment of major depressive disorder: Multicenter, double-blind, randomized, paroxetine-controlled, non-inferiority trial in China, Korea, Taiwan and Brazil".PSYCHIATRY AND CLINICAL NEUROSCIENCES 61.3(2007):295-307.
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