Background: This study is a pre-registration trial of generic duloxetine that was approved by the China Food and Drug Administration (approval number: 2006L01603).
Aims: Compare the treatment efficacy and safety of generic duloxetine to that of paroxetine in patients with major depressive disorders (MDD).
Methods: This was a double-dummy, double-blind, multicenter, positive drug (paroxetine), parallel randomized controlled clinical trial. The 299 patients with MDD recruited for the study were randomly assigned to use duloxetine (n=149; 40-60 mg/d) or paroxetine (n=150; 20 mg/d) for 8 weeks. The Hamilton Depression rating scale (HAMD-17) was administered at baseline and 1, 2, 4, 6, and 8 weeks after starting treatment. Remission was defined as a HAMD-17 score below 8 at the end of the trial, and treatment effectiveness was defined as a decrease in baseline HAMD-17 score of at least 50% by the end of the trial. Safety was assessed based on the reported prevalence and severity of side effects and changes in laboratory and electrocardiographic findings. Three patients in the duloxetine group dropped out before starting medication, so results were analyzed using a modified intention-to-treat (ITT) method with 146 in the experimental group and 150 in the control group.
Results: Both groups experienced 29 dropouts during the 8-week trial. HAMD-17 scores decreased significantly from baseline throughout the trial in both groups. Based on the ITT analysis, at the end of the trial there was no significant difference between the duloxetine group and the paroxetine group in effectiveness (67.1% v. 71.3%, X(2)=0.62 p=0.433), remission rate (41.1% v. 51.3%, X(2)=3.12, p=0.077), or in the incidence of side effects (56.8% v. 54.7%, X(2)=0.14, p=0.705).
Conclusions: Generic duloxetine is as effective and safe as paroxetine in the acute treatment of patients with MDD who seek care at psychiatric outpatient departments in China.
背景: 本研究是经国家食品药品监督管理总局批准的仿制度洛西汀注册前试验（批准号：2006L01603）。.
目的: 比较仿制度洛西汀和帕罗西汀治疗抑郁症患者的疗效和安全性。.
方法: 这是一项双盲双安慰剂 (double dummy)、多中心、有效药物（帕罗西汀）平行随机对照临床试验。将纳入的299 例抑郁症患者随机分组，使用度洛西汀 (n=149; 40-60 mg/d) 或帕罗西汀 (n=150; 20 mg/d) 连续治疗 8 周。在基线和开始治疗后的第 1、2、4、6 和8周使用汉密尔顿抑郁量表(Hamilton Depression rating scale, HAMD-17) 评估。缓解的定义为研究终点 HAMD-17评分低于8分，治疗有效的定义为研究终点HAMD-17得分较基线至少降低了50%。根据报告的不良反应的发生率、严重程度以及实验室检查结果、心电图结果的变化来评估安全性。度洛西汀组中有三例患者在开始用药前退出，采用修正的意向治疗分析 (intention-to-treat, ITT) 方法以比较研究组 146 例患者和对照组150例患者的研究结果。.
结果: 在8周的研究期间两组有均29例患者脱落。与基线比，两组HAMD-17评分在整个试验过程中均显著降低。根据 ITT分析，研究终点时度洛西汀组和帕罗西汀组在疗效方面差异无统计学意义 (67.1% v. 71.3%, X2=0.62, p=0.433)，缓解率 (41.1% v. 51.3%, X2=3.12, p=0.077)及不良作用发生率 56.8% v. 54.7%, X2=0.14, p=0.705) 等方面的差异也无统计学意义。.
结论: 对于在国内精神科门诊就医的抑郁症患者而言，急性期使用仿制度洛西汀与使用帕罗西汀同样安全有效。.
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Keywords: China; duloxetine; efficacy; major depressive disorder; paroxetine; randomized controlled trial; safety.