通用名称

vilazodone hydrochloride

儿科标签批准日期

2020/1/31 0:00:00

特定指示/秒

Major depressive disorder (MDD)

标签更改摘要

- Safety and effectiveness have not been established in pediatric patients for the treatment of MDD. - Efficacy was not demonstrated in two adequate and well controlled, 8-week studies including a total of 1002 pediatric patients ages 7 - years to 17 years of age with MDD. The following adverse reactions were reported in at least 5% of pediatric patients treated with - VIIBRYD and occurred at a rate at least twice that for pediatric patients receiving placebo: nausea, vomiting, diarrhea, abdominal - pain/discomfort, and dizziness. - Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients

治疗类别

N/A

立法类型

PREA + BPCA

产品说明书链接

书号

3.0 2.0 1.0

研究年龄

7 YEARS - 17 YEARS 7 YEARS - 17 YEARS 12 YEARS - 17 YEARS

学习类型

Safety Efficacy,Safety,Pharmacokinetic Efficacy,Safety,Pharmacokinetic

研究设计

Open-Label,Phase 3,Non-Randomized,Long-term Multicenter,Randomized,Active Comparator,Placebo,Double-Blind,Parallel Group Multicenter,Randomized,Placebo,Double-Blind,Parallel Group

登记的患者

N/A 473 529

患者分析

330 470 526

中心的数量

N/A 55 56

国家数量

2 2 1

西班牙裔拉美裔/拉丁裔总计

N/A 64 62

非西班牙裔/非拉丁裔总人数

N/A 406 464

总数#种族不明

N/A 0 0

亚裔学生总数

N/A 7 9

黑人总数

N/A 145 142

白人总数

N/A 299 346

夏威夷或太平洋岛民总数

N/A 3 0

美洲印第安人/阿拉斯加本地人总数

N/A 0 8

其他种族总计

N/A 15 21

未知种族总数

N/A 1 0

国家

United States,Canada United States,Canada United States