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首页> 外文期刊>The journal of clinical psychiatry >Agomelatine prevents relapse in generalized anxiety disorder: A 6-month randomized, double-blind, placebo-controlled discontinuation study
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Agomelatine prevents relapse in generalized anxiety disorder: A 6-month randomized, double-blind, placebo-controlled discontinuation study

机译：阿戈美拉汀可预防广泛性焦虑症的复发：一项为期6个月的随机，双盲，安慰剂对照停药研究

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Objective: This study evaluated the efficacy and tolerability of agomelatine in the prevention of relapse in patients with generalized anxiety disorder (GAD). Method: Patients with GAD (Hamilton Anxiety Rating Scale [HARS] ≥ 22, with items 1 and 2 ≥ 2, item 1 + 2 ≥ 5; Montgomery-Asberg Depression Rating Scale [MADRS] ≤ 16; and < 20% decrease in HARS total score between screening and baseline) who responded to a 16-week course of agomelatine 25-50 mg/d treatment were randomly assigned to receive continuation treatment with agomelatine (n = 113) or placebo (n = 114) for 26 weeks. The main outcome measure was time to relapse during this maintenance period. The estimated risk of relapse was calculated using the Kaplan-Meier method, and groups were compared using a log-rank test stratified for country. The study was undertaken in 31 clinical centers in Canada, Denmark, Estonia, Finland, Hungary, and Sweden from November 2007 to September 2009. Results: During the 6-month maintenance period, the proportion of patients that relapsed during the double-blind period in the agomelatine group (22 patients, 19.5%) was lower than in the placebo group (35 patients, 30.7%). The risk of relapse over time was significantly lower for patients who continued treatment than for those switched to placebo (P = .046, log-rank test stratified for country). Agomelatine was also superior to placebo in preventing relapse in the subset of more severe patients with baseline HARS total score ≥ 25 and CGI-S score ≥ 5. The tolerability of agomelatine was good throughout the study, and there were no differences in discontinuation symptoms after withdrawal of agomelatine in comparison to maintenance on agomelatine. Conclusions: The present study extends the positive findings of an earlier short-term study of agomelatine in GAD, demonstrating that agomelatine is effective and well-tolerated in the longer-term treatment of this chronic disorder. Trial Registration: www.isrctn.org identifier: ISRCTN38094599.
机译：目的：本研究评估了阿戈美拉汀在预防广泛性焦虑症（GAD）患者复发中的疗效和耐受性。方法：GAD患者（汉密尔顿焦虑量表[HARS]≥22，项目1和2≥2，项目1 + 2≥5;蒙哥马利-阿斯伯格抑郁量表[MADRS]≤16;并且HARS降低<20％接受阿戈美拉汀25-50 mg / d治疗16周疗程的患者被随机分配接受阿戈美拉汀（n = 113）或安慰剂（n = 114）连续治疗26周。主要结果指标是在此维护期内的复发时间。使用Kaplan-Meier方法计算估计的复发风险，并使用针对国家/地区分层的对数秩检验比较各组。该研究于2007年11月至2009年9月在加拿大，丹麦，爱沙尼亚，芬兰，匈牙利和瑞典的31个临床中心进行。结果：在6个月的维持期内，双盲期复发的患者比例阿戈美拉汀组（22例，19.5％）低于安慰剂组（35例，30.7％）。持续治疗的患者随着时间推移复发的风险显着低于转用安慰剂的患者（P = .046，按国家进行对数秩检验）。在基线HARS总得分≥25且CGI-S得分≥5的更严重患者中，Agomelatine在预防复发方面也优于安慰剂。在整个研究中阿戈美拉汀的耐受性良好，并且在停药后的停药症状无差异与维持阿戈美拉汀相比，阿戈美拉汀的退出。结论：本研究扩展了先前对阿戈美拉汀进行GAD短期研究的积极发现，表明阿戈美拉汀在长期治疗这种慢性疾病中有效且耐受性良好。试用注册：www.isrctn.org标识符：ISRCTN38094599。

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