Duloxetine Enteric-coated Tablets Versus Paroxetine in the Treatment of Major Depressive Disorder: A Double-blind, Double-dummy, Randomized Controlled Clinical Trial-Journal of Psychiatry and Brain Science-CSCIED科技核心评价数据库-手机版

Duloxetine Enteric-coated Tablets Versus Paroxetine in the Treatment of Major Depressive Disorder: A Double-blind, Double-dummy, Randomized Controlled Clinical Trial

Duloxetine Enteric-coated Tablets Versus Paroxetine in the Treatment of Major Depressive Disorder: A Double-blind, Double-dummy, Randomized Controlled Clinical Trial

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DOI	10.20900/jpbs.20160006
刊名	Journal of Psychiatry and Brain Science JPBS
年，卷(期)	2016, 1(2)
作者	Jicai Wang,
作者单位	1 Department of Psychiatry, the First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan 650032, China; 2 Institute of Mental Health, The Second Xiangya Hospital of Central South University, Changsha, Hunan Province, China; 3 Baylor College of Medicine, Houston, Texas, USA
Abstract	Objective To evaluate the efficacy and safety of duloxetine enteric coated tablets in patients with depressive disorders. Methods A double-blind, double-dummy, parallel randomized controlled study was carried out for 51 patients who met the DSM-IV criteria of depression and depressed episode. 25 of the total patients were treated with duloxetine (40-60 mg·d-1) and the rest were treated with paroxetine (20mg·d-1) for 8 weeks. Efficacy was then assessed by Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Scale(HAMA), Montgomery Depression Rating Scale (MADRS), Sheehan Disability Scale (SDS), visual analogue scale (VAS-PI) and Clinical Global Impression (CGI). Safety assessments included physical examinations, laboratory evaluations, and electrocardiographic findings of adverse events. Assessment time point were evaluated at baseline and 1,2,4,6,8 weeks after starting treatment. Results After 8 weeks of treatment, the total effective rates of duloxetine group and paroxetine group were 72.0% and 73.1% respectively, with no significant difference (t=0.465, P=0.612). The clinical curing rates of duloxetine group and paroxetine group were 20.0% and 23.1% respectively, with no significant difference (t=0.547, P=0.590). The scores of HAMD17, HAMA, MADRS, SDS, VAS-PI and CGI in both groups decreased significantly, with statistical difference between the baseline and other observation time points (P＜0.001). The adverse event rates of the duloxetine group and paroxetine group were 36.0 %and 34.6% respectively, with no significant difference (P＞0.05). The main adverse events of two groups were dry mouth, nausea, dizziness, and stomach discomfort. Conclusions Duloxetine enteric-coated tablet is an effective antidepressant with less side effects, better safety, and more suitable for the treatment of depression patients.
KeyWord	duloxetine enteric-coated tablet; paroxetine; major depressive disorder; efficacy; safety; randomized controlled trials; double-blinded method
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引用本文

Jicai Wang. Duloxetine Enteric-coated Tablets Versus Paroxetine in the Treatment of Major Depressive Disorder: A Double-blind, Double-dummy, Randomized Controlled Clinical Trial, Journal of Psychiatry and Brain Science. 2016; 1; (2). https://doi.org/10.20900/jpbs.20160006.

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