Duloxetine 60 mg once daily dosing versus placebo in the acute treatment of major depression
Duloxetine 60 mg once daily dosing versus placebo in the acute treatment of major depression
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DOI：
10.1016/s0022-3956(02)00060-2
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发表时间：
2002-11-01
影响因子：
4.8
通讯作者：
Demitrack, MA
中科院分区：
文献类型：
--
作者：
Detke, MJ;Lu, YL;Demitrack, MA
现有的重度抑郁症（MDD）疗法要么疗效有限，要么耐受性差。本研究检查了度洛西汀的作用。一种有效且平衡的血清素 (5-HT) 和去甲肾上腺素 (NE) 双重再摄取抑制剂，适用于 MDD 患者。在这项为期 9 周、多中心、双盲、平行组临床试验中，MDD 成年患者 (N = 267) 被随机分配接受度洛西汀（60 毫克/天）或安慰剂治疗。使用 17 项汉密尔顿抑郁评定量表 (HAMD(17)) 评估疗效。疼痛视觉模拟量表 (VAS)。临床严重程度总体印象 (CGI-S)、患者改善总体印象 (PGI-I)。和抑郁生活质量量表（QLDS）。通过评估停药率来评估安全性。不良事件发生率、生命体征和实验室测试。在 9 周治疗结束时，与安慰剂相比，度洛西汀（60 mg QD）显着降低了 HAMD(17) 总分。预计缓解和缓解的概率分别为 65% 和 43%。度洛西汀则分别为 42% 和 28%。安慰剂。度洛西汀还可以减轻整体疼痛、背痛。肩部疼痛和清醒时疼痛的时间明显多于安慰剂。全球改进措施。与安慰剂相比，度洛西汀显着改善了 PGI-I 和 QLDS。度洛西汀治疗的患者 (12.5%) 因不良事件而停药的频率高于安慰剂治疗的患者 (4.3%)。恶心。度洛西汀比安慰剂更容易出现干燥月、头晕和便秘，没有显着的高血压发生率，也没有其他安全问题。度洛西汀 60 毫克每日一次似乎是治疗 MDD 的安全有效的方法。 (C) 2002 Elsevier Science Ltd. 保留所有权利。
Existing therapies for major depressive disorder (MDD) have either limited efficacy and, or poor tolerability. The present Study examined the effects of duloxetine. a potent and balanced dual reuptake inhibitor of serotonin (5-HT) and norepinephrine (NE), in patients with MDD. Adult patients (N = 267) with MDD were randomly assigned to receive duloxetine (60 mg/day) or placebo in this 9-week, multi-center, double-blind, parallel-group clinical trial. Efficacy as evaluated using the 17-item Hamilton Depression Rating Scale (HAMD(17)). Visual Analog Scales (VAS) for pain. Clinical Global Impression of Severity (CGI-S), Patient's Global Impression of Improvement (PGI-I). and Quality of Life in Depression Scale (QLDS). Safety was evaluated by assessing discontinuation rates. adverse event rates, vital signs, and laboratory tests. Duloxetine (60 mg QD) significantly reduced the HAMD(17) total score compared with placebo at the end of 9-week therapy. Estimated probabilities of response and remission,were 65 and 43%. respectively, for duloxetine compared with 42 and 28%. for placebo. Duloxetine also reduced overall pain, back pain. shoulder pain and time in pain while awake significantly more than placebo. Global measures of improvement. including PGI-I and QLDS, were significantly improved by duloxetine compared with placebo. Discontinuations due to adverse events were more frequent for duloxetine-treated patients (12.5 %) than for placebo-treated patients (4.3%). Nausea. dry month, dizziness, and constipation were more frequent for duloxetine than placebo, There was no significant incidence of hypertension, nor an other safety issues. Duloxetine 60 mg administered once daily appears to be a safe and effective treatment for MDD. (C) 2002 Elsevier Science Ltd. All rights reserved.