Department of Psychiatry, University Health Network, Toronto, Ontario, Canada.
CNS Drugs. 2010 Jun;24(6):479-99. doi: 10.2165/11534420-000000000-00000.
To demonstrate the clinical effectiveness of an antidepressant drug requires evidence beyond short- and long-term efficacy, including a favourable adverse-effect profile and sustained treatment adherence. Under these conditions, patients should experience enhanced social and functional outcomes. The novel antidepressant agomelatine, a melatonergic MT(1)/MT(2) receptor agonist with serotonin 5-HT(2C) receptor antagonist activity, displays antidepressant efficacy with a favourable adverse-effect profile that is associated with good patient adherence. Specifically, agomelatine has demonstrated significant short-term (6-8 weeks) and sustained (6 months) antidepressant efficacy relative to placebo, as well as evidence of relapse prevention (up to 10 months). In head-to-head comparative studies with venlafaxine and sertraline, there was evidence of early (at 1-2 weeks) and sustained (at 6 months) advantages for agomelatine. In addition to evidence of early efficacy, agomelatine also restored disturbed sleep-wake patterns early in treatment. There was no evidence of antidepressant-induced sexual dysfunction, weight gain or discontinuation-emergent symptoms. Agomelatine has demonstrated a range of properties that suggest it could offer advantages over current treatments for major depressive disorder, although further comparative trials are still required, as is evidence from real-world clinical practice.
要证明一种抗抑郁药物的临床疗效，需要超出短期和长期疗效的证据，包括有利的不良反应谱和持续的治疗依从性。在这些条件下，患者应该经历增强的社会和功能结果。新型抗抑郁药阿戈美拉汀是一种具有褪黑素能 MT(1)/MT(2)受体激动作用和 5-羟色胺 5-HT(2C)受体拮抗作用的药物，具有抗抑郁疗效和有利的不良反应谱，与良好的患者依从性相关。具体来说，阿戈美拉汀显示出相对于安慰剂的显著短期（6-8 周）和持续（6 个月）抗抑郁疗效，以及预防复发的证据（长达 10 个月）。在与文拉法辛和舍曲林的头对头比较研究中，阿戈美拉汀显示出早期（1-2 周）和持续（6 个月）的优势。除了早期疗效的证据外，阿戈美拉汀还能在治疗早期恢复紊乱的睡眠-觉醒模式。没有抗抑郁药引起的性功能障碍、体重增加或停药后出现症状的证据。阿戈美拉汀表现出一系列特性，表明它可能优于目前治疗主要抑郁症的药物，尽管仍需要进一步的比较试验，以及来自真实临床实践的证据。
