Bremner J D
Bremner Research Institute, Olympia, WA 98502, USA.
J Clin Psychiatry. 1995 Nov;56(11):519-25.
A 6-week, double-blind, dose titration study was performed to evaluate efficacy and safety of the new antidepressant Org 3770 in comparison with amitriptyline and placebo.
One hundred fifty outpatients of both sexes, 18 years and older, with a DSM-III diagnosis of major depressive episode, were randomly assigned to 6 weeks of treatment with Org 3770, amitriptyline, or placebo.
At baseline, mean 17-item Hamilton Rating Scale for Depression (HAM-D) scores of all treatment groups were higher than 25, thus indicating that a large proportion of severely depressed patients entered the study. The overall mean daily doses were 22 mg/day for Org 3770, 133 mg/day for amitriptyline, and 4.9 capsules/day for placebo. The majority of times assessments were made, both active drugs produced significantly greater improvements than placebo on all efficacy variables (17-item HAM-D, Montgomery-Asberg Depression Rating Scale, Clinical Global Impressions, and Zung Self-Rating Depression Scale). After 6 weeks of treatment, significantly greater (p < or = .05) proportions of patients in both active treatment groups (70% in the Org 3770- and 58% in the amitriptyline-treatment groups) than in the placebo-treatment group (33%) were HAM-D responders. Org 3770 was well tolerated in this study; dry mouth and somnolence were the only adverse experiences that occurred significantly more frequently with Org 3770- than with placebo-treated patients. By contrast, treatment with amitriptyline was related to significantly higher rates of dry mouth, constipation, and dyspepsia as compared with both Org 3770 and placebo, and significantly higher rates of somnolence as compared with placebo.
In this study, Org 3770 was as effective as amitriptyline in the treatment of major depression, with advantages regarding improvements of depressed mood (HAM-D Item 1), responder rates, and safety.
开展了一项为期6周的双盲剂量滴定研究，以评估新型抗抑郁药Org 3770与阿米替林及安慰剂相比的疗效和安全性。
150名年龄在18岁及以上、被诊断为DSM-III重度抑郁发作的门诊患者，随机分配接受为期6周的Org 3770、阿米替林或安慰剂治疗。
在基线时，所有治疗组的17项汉密尔顿抑郁评定量表（HAM-D）平均得分均高于25分，这表明很大比例的重度抑郁患者进入了该研究。Org 3770的总体日均剂量为22毫克/天，阿米替林为133毫克/天，安慰剂为4.9粒胶囊/天。在大多数评估时间点，两种活性药物在所有疗效变量（17项HAM-D、蒙哥马利-阿斯伯格抑郁评定量表、临床总体印象和zung自评抑郁量表）上的改善均显著优于安慰剂。治疗6周后，两个活性治疗组（Org 3770治疗组为70%，阿米替林治疗组为58%）中HAM-D反应者的比例显著高于安慰剂治疗组（33%）（p≤0.05）。在本研究中，Org 3770耐受性良好；口干和嗜睡是仅有的在接受Org 3770治疗的患者中比接受安慰剂治疗的患者更频繁出现的不良体验。相比之下，与Org 3770和安慰剂相比，阿米替林治疗导致口干、便秘和消化不良的发生率显著更高，与安慰剂相比，嗜睡发生率显著更高。
在本研究中，Org 3770在治疗重度抑郁症方面与阿米替林同样有效，在改善抑郁情绪（HAM-D第1项）、反应率和安全性方面具有优势。
