Neuroscience and Imaging Department, University of Chieti, Chieti, Italy.
J Biol Regul Homeost Agents. 2011 Jan-Mar;25(1):109-14.
Despite a wide range of available antidepressants, the effect of the treatment is often suboptimal and there is a need for more effective and better tolerated drugs. Unlike other antidepressants, agomelatine represents a new approach to depression with an innovative mechanism of action. It is an agonist of melatoninergic receptors MT1 and MT2 and a selective antagonist of 5-HT2c receptors. In this open-label 8-week study we aimed to investigate the efficacy of agomelatine on depressive symptoms in patients with major depression. Secondary endpoints were the effect of agomelatine on anhedonia. Thirty major depressive patients received a flexible dose (25-50 mg; per os, daily) of agomelatine. Depressive (Hamilton Depression Scale) and anxious (Hamilton Anxiety Scale) symptoms, anhedonia (Snaith Hamilton Rating Scale), and sleep quality (Leeds Sleep Evaluation Questionnaire) were assessed. Twenty-four patients (80%) completed 8 weeks of treatment. Significant improvements were seen at all visits on the HAM-D (p<.05), HAM-A(p<.01), SHAPS (p<.05), LSEQ (p<.05). Nine subjects (30%) were responders and 5 (17%) remitters at week 1; 18 (60%) were remitters by the end of the trial. There was no serious adverse event. No aminotrasferase elevations were noted. In line with previous studies, in which agomelatine was associated with early clinical improvement, this study also provides evidence of an early response and the findings of improvements in depression scores. Moreover, this is the first study where agomelatine was effective in the treatment of anhedonia. Additional trials are needed to delineate the place of agomelatine in the contemporary pharmacotherapy for depressive disorders.
尽管有多种可用的抗抑郁药，但治疗效果往往并不理想，因此需要更有效且耐受性更好的药物。与其他抗抑郁药不同，阿戈美拉汀代表了一种治疗抑郁症的新方法，具有创新的作用机制。它是褪黑素能受体 MT1 和 MT2 的激动剂，5-HT2c 受体的选择性拮抗剂。在这项开放标签的 8 周研究中，我们旨在研究阿戈美拉汀治疗重性抑郁症患者抑郁症状的疗效。次要终点是阿戈美拉汀对快感缺失的影响。30 名重性抑郁症患者接受了阿戈美拉汀的灵活剂量（25-50mg；口服，每日）治疗。评估了抑郁（汉密尔顿抑郁量表）和焦虑（汉密尔顿焦虑量表）症状、快感缺失（Snaith 汉密尔顿评分量表）和睡眠质量（利兹睡眠评估问卷）。24 名患者（80%）完成了 8 周的治疗。在所有就诊时，HAM-D（p<.05）、HAM-A（p<.01）、SHAPS（p<.05）和 LSEQ（p<.05）均有显著改善。第 1 周时有 9 名患者（30%）有反应，5 名患者（17%）有缓解；试验结束时有 18 名患者（60%）有缓解。没有严重不良事件。没有氨基转移酶升高。与之前的研究一致，阿戈美拉汀与早期临床改善相关，本研究也提供了早期反应的证据，以及抑郁评分改善的结果。此外，这是第一项证明阿戈美拉汀在治疗快感缺失方面有效的研究。需要进一步的试验来确定阿戈美拉汀在当代抗抑郁药物治疗中的地位。
