Trintellix tablets
儿科标签批准日期
2021/1/22 0:00:00
特定指示/秒
Major Depressive Disorder
标签更改摘要
- Safety and effectiveness have not been established in pediatric patients for the treatment of MDD.
- Efficacy was not established in an 8-week, randomized, double-blind, placebo-controlled, active-reference study in 615 pediatric patients 12 to 17 years of age with MDD.
- The primary efficacy endpoint was change from double-blind baseline to Week 8 on the Children’s Depression Rating Scale-Revised version. The effect of treatment with vortioxetine was not significantly different from placebo.
- In this age group, adverse reactions were generally similar to those reported in adults.
- Antidepressants, such as vortioxetine, increase the risk of suicidal thoughts and behaviors in pediatric patients.
- Information about false positive result in urine immunoassays for methadone was added to labeling.
- The terms "headache," "hyperhidrosis," and "hyperprolactinemia" were added to the Adverse Reactions Postmarketing Experience section.
- Information on adverse reactions, and clinical trial.
研究年龄
7 YEARS - 17 YEARS
7 YEARS - 17 YEARS
7 YEARS - 18 YEARS
7 YEARS - 11 YEARS
12 YEARS - 17 YEARS
学习类型
Pharmacokinetic,Tolerability
Safety
Safety
Safety
Efficacy,Safety,Tolerability
研究设计
Multicenter,Open-Label,Prospective
Multicenter,Open-Label,Long-term
Multicenter,Open-Label,Long-term
Multicenter,Randomized,Active Comparator,Placebo,Double-Blind,Parallel Group
Multicenter,Randomized,Active Comparator,Placebo,Double-Blind,Parallel Group
西班牙裔拉美裔/拉丁裔总计
N/A
N/A
N/A
N/A
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非西班牙裔/非拉丁裔总人数
N/A
N/A
N/A
N/A
N/A
总数#种族不明
N/A
N/A
N/A
N/A
N/A
夏威夷或太平洋岛民总数
0
N/A
N/A
N/A
0
美洲印第安人/阿拉斯加本地人总数
0
N/A
N/A
N/A
0
国家
United States,Germany
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N/A
N/A
United States,Bulgaria,Canada,Colombia,Estonia,France,Germany,Hungary,Italy,Korea, Republic of,Latvia,Mexico,Poland,Russian Federation,Serbia,South Africa,Spain,Ukraine,United Kingdom