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首页> 外文期刊>The journal of clinical psychiatry >Extended release quetiapine fumarate monotherapy in major depressive disorder: a placebo- and duloxetine-controlled study.
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Extended release quetiapine fumarate monotherapy in major depressive disorder: a placebo- and duloxetine-controlled study.

机译：缓释喹硫平富马酸酯单药治疗主要抑郁症：安慰剂和度洛西汀对照研究。

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OBJECTIVE: To evaluate the efficacy and tolerability of once-daily extended release quetiapine fumarate (quetiapine XR) as monotherapy treatment for major depressive disorder (MDD). METHOD: This 8-week (6-week active-treatment, randomized phase; 2-week posttreatment drug-discontinuation/tapering phase), multicenter, double-blind, randomized, parallel-group, placebo- and active-controlled, phase 3 study was conducted between April 2006 and May 2007. In total, 612 patients with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)-defined MDD were randomly assigned to quetiapine XR 150 mg/day or 300 mg/day, duloxetine 60 mg/day (active control), or placebo. The primary endpoint was the change from baseline to week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. RESULTS: At week 6, both doses of quetiapine XR (p < .001) and duloxetine (p < .01) significantly reduced mean MADRS total score versus placebo. A significant reduction was seen at week 1 with quetiapine XR 150 mg/day and 300 mg/day versus placebo (p < .01), but not with duloxetine. Response rates (>or= 50% reduction in MADRS total score) at week 6 were significantly higher for both doses of quetiapine XR (p < .01) and duloxetine (p < .05) versus placebo. Remission rates (MADRS score
机译：目的：评估每日一次缓释富马酸喹硫平（喹硫平XR）作为单药治疗重大抑郁症（MDD）的疗效和耐受性。方法：这8周（6周积极治疗，随机阶段; 2周治疗后停药/渐减阶段），多中心，双盲，随机，平行组，安慰剂和主动控制的3期研究在2006年4月至2007年5月之间进行。总共将612例精神疾病诊断和统计手册，第四版（DSM-IV）定义的MDD患者随机分配至喹硫平XR 150 mg /天或300 mg /天，度洛西汀60毫克/天（主动对照）或安慰剂。主要终点是蒙哥马利-阿斯伯格抑郁量表（MADRS）总分从基线到第6周的变化。结果：在第6周，喹硫平XR（p <.001）和度洛西汀（p <.01）的剂量均较安慰剂显着降低了平均MADRS总评分。与安慰剂相比，喹硫平XR 150 mg / day和300 mg / day在第1周时观察到显着降低（p <.01），但度洛西汀则没有。与安慰剂相比，喹硫平XR（p <.01）和度洛西汀（p <.05）的剂量在第6周的缓解率（或MADRS总评分降低50％以上）显着更高。与安慰剂相比，喹硫平XR 300 mg /天和度洛西汀的缓解率（MADRS得分<或= 8）显着更高（p <.05），但喹硫平XR 150 mg / day的缓解率则没有。汉密尔顿抑郁量表，焦虑量汉密尔顿量表和临床总体印象-疾病严重程度总分和临床总体印象-改善分数为1或2（“大大改善”）的患者比例得到显着改善两种剂量的喹硫平XR和度洛西汀与安慰剂比较。报告的最常见不良事件为喹硫平XR出现口干，镇静和嗜睡感，度洛西汀引起恶心，头痛，头晕和口干。结论：喹硫平XR单一疗法（150 mg /天和300 mg /天）在治疗MDD患者中有效，安全性和耐受性与喹硫平XR的已知特征一致，并在第1周出现症状改善。试验注册：clinicaltrials.gov标识符：NCT00321490。

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