Brintellix (vortioxetine) tablets
Brintellix (vortioxetine) tablets 沃替西汀片
The FDA has approved Brintellix (vortioxetine; Takeda and Lundbeck) for the treatment of adults with major depressive disorder.
This approval was based on a comprehensive global clinical trial program which included six positive 6–8 week short-term studies, including one study in the elderly.
RELATED: Psychiatric Disorders Resource Center
月30日，美国食品药品管理局（FDA）批准Brintellix（Vortioxetine）用于治疗成人重型抑郁症。
重型抑郁症（MDD）的主要特征为心境改变及其他一系列的症状，对患者的工作能力、睡眠、学习、饮食及享受当下的快乐产生困扰。抑郁症状可在一生中多次复发，但部分患者也可能仅经历一次。MDD的其它体征和症状包括对日常活动失去兴趣、体重或饮食发生明显变化、失眠或嗜睡、坐立不安/来回走动（激越）、疲劳、罪恶感或无价值感、思维迟缓、注意受损、自杀未遂或自杀想法。并非所有MDD患者均经历相同的症状。
“重型抑郁症具有致残性，使人不能正常工作，”FDA药物评价与研究中心精神病学产品部门代理主任、医学博士Mitchel lMathis称，“鉴于药物对个体的影响不同，所以抗抑郁治疗选择的多样化是很重要的。”
在6项临床研究中，MDD成人患者被随机给予Brintellix或安慰剂，这6项临床研究证实Brintellix可有效抗抑郁。另有一项临床研究显示，Brintellix降低了患者治疗后复发的可能性。这些研究在美国及其它国家完成。
据临床试验报道，Brintellix最常见的副作用包括恶心、便秘及呕吐。Brintellix片剂可供使用的规格有5mg、10mg、15mg和20mg。
Brintellix与其它抗抑郁药均有黑框警告及用药指南，以提醒患者和医生，这些抗抑郁药在初始治疗期间可能增加儿童、青少年及18至24岁青壮年自杀观念及行为的风险；而研究显示，24岁以上成年人的自杀风险似乎没有增加，而65岁及以上年龄成年患者的该风险或降低。开始抗抑郁治疗时，应严密监测患者的病情恶化及自杀行为。
Brintellix由武田制药与灵北制药共同上市销售。
The primary efficacy measure was the mean change from baseline to endpoint in the Hamilton Depression Scale (HAMD-24) total score in two short-term studies, including the elderly study, and the Montgomery-Asberg Depression Rating Scale (MADRS) total score in the other studies.
In addition, the program included a positive 24–64 week long-term maintenance study in which Brintellix treatment resulted in a statistically significant longer time to recurrence of depressive episodes (defined as a MADRS total score ≥22 or as judged by the investigator) compared to placebo.
The mechanism by which vortioxetine exerts its antidepressant effects is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin.
Vortioxetine is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. The contribution of these activities to the antidepressant effect of vortioxetine has not been established.
