Duloxetine in the treatment of major depressive disorder: A double-blind clinical trial
Duloxetine in the treatment of major depressive disorder: A double-blind clinical trial
复制标题
DOI：
10.4088/jcp.v63n0309
复制
发表时间：
2002-03-01
影响因子：
5.3
通讯作者：
Demitrack, MA
中科院分区：
文献类型：
--
作者：
Goldstein, DJ;Mallinckrodt, C;Demitrack, MA
背景：盐酸度洛西汀是一种5-羟色胺和去甲肾上腺素的双重再摄取抑制剂，对其治疗抑郁症的疗效和安全性/耐受性进行了评估。方法：在一项为期8周的多中心、双盲、安慰剂对照研究中，173例DSM-IV重度抑郁症患者被随机分配到安慰剂组(N=70)、度洛西汀组(N=70)或氟西汀组(N=70)，每日1次，每次20次。33例。度洛西汀的剂量在前3周强制滴定方案从40毫克(20毫克，每天2次)滴定。至120毫克/天(60毫克，每天一次)。患者被要求有临床总体印象(CGI)-疾病严重程度量表至少中等严重程度(大于或等于4)和17项汉密尔顿抑郁量表(HAM-D-17)总分至少15分。患者在过去一年内不能有任何当前除严重抑郁障碍以外的DSM-IV轴心I诊断，或任何焦虑障碍作为主要诊断，不包括特定的恐惧症。一次疗效评定为HAM-D-17总分，二次评定包括蒙哥马利-阿斯伯格抑郁量表、CGI-疾病严重程度和CGI-改善程度、患者总体改善印象，通过记录停药率和治疗紧急不良事件的发生率以及生命体征和实验室分析来评估安全性。结果：度洛西汀在HAM-D-17的变化方面优于安慰剂(p=.009)。度洛西汀的估计有效率和缓解率分别为%和56%，而氟西汀分别为52%和30%，安慰剂分别为48%和32%。度洛西汀在主要和大部分次要结果指标上均优于氟西汀。总体而言，度洛西汀耐受性良好；76%的患者达到了最大剂量，与安慰剂组相比，度洛西汀治疗患者报告的副反应中仅有失眠和乏力的频率更高(p<；0.05)。结论：这些数据表明度洛西汀治疗重度抑郁障碍有效，耐受性好，安全性好。
Background: Duloxetine hydrochloride, a dual reuptake inhibitor of serotonin and norepinephrine, was evaluated for therapeutic efficacy and safety/tolerability in the treatment of major depression.Method: In an 8-week multicenter, double-blind, placebo-controlled study, 173 patients (aged 18-65 years) with DSM-IV major depressive disorder were randomly allocated to receive placebo (N = 70), duloxetine (N = 70), or fluoxetine, 20 trig q.d. (N = 33). Duloxetine dose was titrated in the first 3 weeks in a forced-titration regimen from 40 mg (20 mg b.i.d.) to 120 mg/day (60 mg b.i.d.). Patients were required to have a Clinical Global Impressions (CGI)-Severity of Illness scale score of at least moderate severity (greater than or equal to 4) and a 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score of at least 15. Patients could not have had any current primary DSM-IV Axis I diagnosis other than major depressive disorder, or any anxiety disorder as a primary diagnosis within the past year, excluding specific phobias. The primary efficacy measurement was the HAM-D-17 total score, and secondary measures included the Montgomery-Asberg Depression Rating Scale, CGI-Severity of Illness and CGI-Improvement, and Patient Global Impression of Improvement, Safety was evaluated by recording the occurrence of discontinuation rates and treatment-emergent adverse events and by measurement of vital signs and laboratory analytes.Results: Duloxetine was superior to placebo in change on the HAM-D-17 (p = .009). Estimated probabilities of response and remission were 64% and 56%, respectively, for duloxetine, compared with 52% and 30% for fluoxetine and 48% and 32% for placebo. Duloxetine was numerically superior to fluoxetine on the primary and most of the secondary outcome measures. In general, duloxetine was well tolerated; 76% of patients achieved the maximum dose, and insomnia and asthenia were the only adverse events reported statistically significantly (p < .05) more frequently by duloxetine-treated patients compared with placebo-treated patients.Conclusion: These data indicate that duloxetine is efficacious for the treatment of major depressive disorder and is well tolerated and safe.