安郁沛勃胶囊(Anyu Peibo Capsule)

概要

基本信息

药物类型

中药

别名-

靶点-

作用机制-

治疗领域

其他疾病

在研适应症-

非在研适应症

抑郁症重度抑郁症中度重度抑郁症

原研机构

上海市精神卫生中心（上海市心理咨询培训中心）

在研机构-

非在研机构

苏州颐华生物医药技术有限公司上海颐华生物医药有限公司

上海市精神卫生中心（上海市心理咨询培训中心）

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)无进展

特殊审评-

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关联

7

项与安郁沛勃胶囊相关的临床试验

NCT04210973 / Unknown status临床3期IIT

Efficacy and Safety Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Ⅲ Randomized, Double-Blind, Placebo-Paralleled, Multicenter Clinical Trial

The purpose of this study is to evaluate the efficacy and safety of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression.

开始日期2020-01-23

申办/合作机构

上海市精神卫生中心（上海市心理咨询培训中心）

[+1]

CTR20191740 / Active, not recruiting临床3期

随机、双盲、多中心、安慰剂平行对照，评价安郁沛勃胶囊治疗抑郁症的有效性和安全性的Ⅲ期临床试验

以安慰剂为对照，评价安郁沛勃胶囊治疗抑郁症的有效性和安全性

开始日期2020-01-19

申办/合作机构

苏州颐华生物医药技术有限公司

[+1]

NCT03183505 / Completed临床2期IIT

Safety and Efficacy Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Ⅱb Stratified Randomized, Double-Blind, Placebo-Paralleled, Multicenter Clinical Trial

The purpose of this study is to evaluate the safety and efficacy of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression. And to provide some scientific evidence for protocol designing in following phase Ⅲ clinical trial.

开始日期2017-06-30

申办/合作机构

上海市精神卫生中心（上海市心理咨询培训中心）

[+1]

100 项与安郁沛勃胶囊相关的临床结果

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100 项与安郁沛勃胶囊相关的转化医学

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100 项与安郁沛勃胶囊相关的专利（医药）

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2

项与安郁沛勃胶囊相关的文献（医药）

2023-01-01·Therapeutic Advances in Psychopharmacology

A 6-week, phase IIb, randomized, double-blind, placebo-controlled trial of Anyu Peibo capsules for the treatment of major depressive disorder in adults

Article

作者: Li, Yan ; Yu, Yimin ; He, Shen ; Ding, Xiujuan ; Li, Huafang ; Shen, Yifeng ; Tao, Zhiping ; Lu, Yazhou ; Yin, Jiahui ; Niu, Yajuan ; Li, Lehua ; Fang, Maosheng ; Wang, Xue ; Huang, Jingjing ; Wu, Bin ; Li, Kan

Background: Almost one-third of patients with major depressive disorder (MDD) do not respond to conventional antidepressants, and new treatments for MDD are urgently needed. Objectives: This phase IIb clinical trial was designed to evaluate the efficacy and safety of Anyu Peibo capsules in the treatment of adults with MDD. Design: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. Methods: A total of 172 patients with MDD from nine study centers were randomized (1:1) to receive placebo ( n = 86) or oral Anyu Peibo capsules (0.8 g) twice per day ( n = 86) for 6 weeks. The primary endpoint was the change in the Montgomery Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6, analyzed using an analysis of covariance (ANCOVA) approach with the baseline MADRS score, center effect and center by group interaction as the covariates. Other efficacy endpoints and variables included clinical response and remission rates according to the MADRS and the 17-item Hamilton Depression Rating Scale (HAMD-17) scores, the change in the HAMD-17, Clinical Global Impression – Severity scale and Clinical Global Impression – Improvement scale scores and the reduction in the Hamilton Anxiety Scale from baseline to week 6. Results: The mean baseline MADRS total scores were 29.20 and 29.72 in the Anyu Peibo ( n = 82) and placebo groups ( n = 81), respectively. The least squares mean change in the MADRS score from baseline to week 6 was 16.59 points in the Anyu Peibo group and 14.51 points in the placebo group. Although there were greater reductions in the MADRS score from baseline to week 6 in the Anyu Peibo capsule group compared to the placebo group, the difference did not reach statistical significance (least-squares mean difference, 2.07 points; 95% confidence interval, −0.27 to 4.41; p = 0.0819). The results of sensitivity analyses by ANCOVA with the last observation carried forward method for missing data indicated that the administration of Anyu Peibo capsules may lead to a significant reduction in depressive symptoms compared to the placebo (least-squares mean difference: 3.29 points; 95% confidence interval: 0.64–5.93; p = 0.0152). Furthermore, Anyu Peibo capsules showed significant benefits over placebo when the change in the HAMD-17 score from baseline to week 6 was evaluated as the secondary analysis ( t = 2.01; 95% confidence interval, 0.03–4.23; p = 0.0464). Conclusion: Anyu Peibo capsules may have an effective and safe antidepressant effect, which warrants further research.

2021-12-01·Trials4区 · 医学

The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial

4区 · 医学

ArticleOA

作者: Li, Yan ; Chen, Wu ; Jiang, Yi ; Zheng, Qingshan ; Li, Huafang ; Shen, Yifeng ; Huang, Jingjing ; Yu, Yimin

AbstractBackgroundMajor depressive disorder is the second leading cause of years lost to disability worldwide. Anyu Peibo Capsule has been shown to be effective and safe in phase II trials.MethodsThis clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group, phase III trial of Anyu Peibo Capsule in China. The aim is to test whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcomes in adults (aged 18 to 65 years) with MDD. Patients will receive an 8-week treatment of Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change from baseline in the total score for the Montgomery-Asberg Depression Rating Scale at the end of the 8-week treatment.DiscussionThe trial aims to provide pivotal evidence for the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder.Trial registration

ClinicalTrials.gov

NCT04210973. Registered on December 26, 2019

1

项与安郁沛勃胶囊相关的新闻（医药）

2022-09-20

·国家药品监督管理局政务服务门户

2022年09月20日药品通知件待领取信息发布

序号受理号药品名称申请人签发日期1CXZB2200004国安郁沛勃胶囊苏州颐华生物医药技术股份有限公司2022年09月16日2CYHB2150675国阿司匹林肠溶片桂林南药股份有限公司2022年09月16日3CYHB2150748国阿司匹林肠溶片乐普恒久远药业有限公司2022年09月16日4CYHB2151075国依托泊苷注射液齐鲁制药（海南）有限公司2022年09月16日5CYHB2201082国布洛芬混悬液上海强生制药有限公司2022年09月16日6CYHS1401431唑来膦酸注射液石药集团欧意药业有限公司2022年09月16日7CYHS2000897国注射用阿扎胞苷健进制药有限公司2022年09月16日8CYHS2101904国赖氨洛芬注射液四川维奥制药有限公司2022年09月16日9CYHS2200572国盐酸鲁拉西酮片丽珠集团丽珠制药厂2022年09月16日10CYZB2101713国蒺藜皂苷胶囊长白山制药股份有限公司2022年09月16日11CYZB2101714国蒺藜皂苷提取物长白山制药股份有限公司2022年09月16日12CYZB2101835国牛黄上清丸河南省广康药业有限公司2022年09月16日13JYHB2240001国玻璃酸钠注射液明治制果药业株式会社；广东明治医药有限公司2022年09月15日

100 项与安郁沛勃胶囊相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
重度抑郁症	临床3期	中国	上海市精神卫生中心（上海市心理咨询培训中心）	2020-01-23
中度重度抑郁症	临床3期	中国	上海市精神卫生中心（上海市心理咨询培训中心）	2020-01-23
抑郁症	临床3期	中国	苏州颐华生物医药技术有限公司	2015-03-25
抑郁症	临床3期	中国	上海颐华生物医药有限公司	2015-03-25