2014年1月23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。
BRINTELLIX (vortioxetine)片，为口服使用
美国初次批准：2013
适应证和用途
BRINTELLIX是适用为重度抑郁症(MDD)的治疗。
剂量和给药方法
（1）推荐开始剂量是10mg口服给予每天1次不受食物影响
（2）当耐受剂量应增加至20mg/day。
（3）对不能耐受较高剂量患者考虑5mg/day。
（4）BRINTELLIX可突然停药。 但是，建议如可能完全终止前1周15 mg/day或20mg/day剂量减低至10 mg/day。
（5）在已知CYP2D6代谢差患者中最大推荐剂量为10mg/day。
剂型和规格
可得到5mg，10mg，15mg,和20mg立即释放BRINTELLIX片。
禁忌证
（1）对vortioxetine或BRINTELLIX制剂任何组分超敏性。
（2）单胺氧化酶抑制剂(MAOIs)：不要意向使用MAOIs与BRINTELLIX或停止用BRINTELLIX治疗21天内治疗精神疾病。在一种MAOI停止14天内不要意向使用BRINTELLIX治疗精神疾病。此外，正在用利奈唑胺[linezolid]或静脉亚甲蓝[methylene blue]治疗患者不要开始BRINTELLIX (4)。
（1）用5-HT能抗抑郁药(SSRIs，SNRIs，和其他)，包括用BRINTELLIX，两者当单独用，但尤其是当与其他5-HT能药物共同给药时曾报道5-HT综合证(包括曲坦类药物[triptans]，三环类抗抑郁药[tricyclic antidepressants]，芬太尼[fentanyl]，锂[lithium]，曲马多[tramadol]，色氨酸，丁螺环酮[buspirone]，和圣约翰草[St. John's Wort])。如果出现这种症状，终止BRINTELLIX和开始支持治疗。如果临床上想要BRINTELLIX与其他5-HT药物的同时使用，患者应注意对5-HT综合证潜在风险增加，尤其是治疗开始和剂量增加期间。
（2）用5-HT能抗抑郁药治疗(SSRIs，SNRIs，和其他)可能增加异常出血的风险。当BRINTELLIX与非甾体抗炎药(NSAIDs)，阿司匹林[aspirin]，或影响凝血其他药物共同给药时患者应谨慎注意关于出血风险增加。
（3）抗抑郁药治疗可出现躁狂/轻躁狂的激活。筛选躁郁症患者。
（4）与抗利尿激素不适当分泌综合证(SIADH)可能伴发低钠血症
不良反应
最常见不良反应(发生率 ≥5%和至少安慰剂率的2倍)是：恶心，便秘和呕吐(6)。
报告怀疑不良反应，联系Takeda Pharmaceuticals电话1-877-TAKEDA-7(1-877-825-3327)或FDA电话1¬800-FDA-1088或www.fda.gov/medwatch.
药物相互作用
（1）CYP2D6的强抑制剂：当强CYP2D6抑制剂(如，安非他酮[bupropion]，氟西汀[fluoxetine]，帕罗西汀[paroxetine]，或奎尼丁[quinidine])被共同给药减低BRINTELLIX剂量一半(2.6和7.3)。
（2）强CYP诱导剂：当一种强CYP诱导剂(如，利福平[rifampin]，卡马西平[carbamazepine]，或苯妥英钠[phenytoin])被共同给药共14天以上考虑增加BRINTELLIX剂量。最大推荐剂量不应超过原剂量3倍。
特殊人群中使用
（1）妊娠：根据动物资料，BRINTELLIX可能致胎儿危害。
（2）哺乳母亲：终止BRINTELLIX或终止哺乳。
Are allergic to vortioxetine or any of the ingredients in BRINTELLIX Take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid; do not take an MAOI within 21 days of stopping BRINTELLIX; do not start BRINTELLIX if you stopped taking an MAOI in the last 14 days BRINTELLIX may cause serious side effects including: Serotonin Syndrome: A potentially life-threatening problem that can happen when medicines such as BRINTELLIX are taken with certain other medicines.
Symptoms may include agitation, hallucinations, coma or other changes in mental status; problems controlling movements or muscle twitching, stiffness or tightness; fast heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting or diarrhea.
Abnormal bleeding or bruising: BRINTELLIX and other serotonergic antidepressant
medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin. Manic episode: Symptoms may include greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual. Low salt (sodium) levels in the blood: Symptoms may include headache; difficulty concentrating, memory changes or confusion; weakness and unsteadiness on your feet and in severe or sudden cases hallucinations, fainting, seizures or coma. If not treated, severe low sodium levels can cause death. Before starting BRINTELLIX, tell your healthcare provider if you have or had liver problems, seizures or convulsions, bipolar disorder (manic depression) or mania, low salt (sodium) levels in your blood, bleeding problems, drink alcohol, have any other medical conditions
or if you are pregnant, nursing, plan to become pregnant, or plan to nurse. BRINTELLIX and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together. Tell your healthcare provider if you plan on or are taking any other prescription and non-prescription medicines, vitamins and herbal supplements including medicines for migraine headaches, such as triptans; medicines used to treat mood, anxiety, psychotic or thought disorders such as tricyclics, lithium, SSRIs, SNRIs, bupropion, buspirone or antipsychotics; MAOIs including linezolid (a specific antibiotic); over-the-counter supplements such as
tryptophan or St. John's wort; and the following medicines: aspirin, NSAIDs, warfarin (Coumadin®, Jantoven®), diuretics, rifampicin, carbamazepine, phenytoin, quinidine, tramadol or fentanyl. Common side effects of BRINTELLIX include: nausea, constipation or vomiting. These are not all the possible side effects of BRINTELLIX.
Do not start or stop taking BRINTELLIX without talking to your healthcare provider first.
Suddenly stopping BRINTELLIX when you take higher doses may cause you to have side effects including headache, stiff muscles, mood swings, sudden outbursts or anger,
dizziness or feeling lightheaded, or runny nose. Until you know how BRINTELLIX affects you, do not drive, operate heavy machinery or engage in other dangerous activities. Avoid drinking alcohol while taking BRINTELLIX. Talk to your healthcare provider.