Evidence map›Paper›PMID 34479619›Full record

ArticleTrials2021

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.

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

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04210973 (Efficacy and Safety Study of Anyu Peibo in the Treatment of Major Depressive Disorder), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04210973 phase3unknown statusnot on this map

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

TypeinterventionalSponsorShanghai Mental Health CenterRan2020 to 2021Enrolled266ConditionsMajor Depressive DisorderArmsAnyu Peibo, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Jingjing HuangShanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, 200030, People's Republic of China.
Yimin YuShanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, 200030, People's Republic of China.
Yi JiangSu Zhou YiHua Biotechnology Co. Ltd., Suzhou, People's Republic of China.
Wu ChenSu Zhou YiHua Biotechnology Co. Ltd., Suzhou, People's Republic of China.
Yan LiShanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, 200030, People's Republic of China.
Yifeng ShenShanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, 200030, People's Republic of China.
Qingshan ZhengShanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Huafang LiShanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai, 200030, People's Republic of China. lihuafang3@163.com.ORCID http://orcid.org/0000-0003-3965-969X

Funding

China National Major Project for IND 2018ZX09734-005Shanghai Clinical Research Center for Mental Health 19MC1911100
6 · The paper itself

Abstract

backgroundMajor 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. DISCUSSION: The trial aims to provide pivotal evidence for the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder.

trial registrationClinicalTrials.gov NCT04210973 . Registered on December 26, 2019.

Indexed as

Major Depressive DisorderAdultChinaDouble-Blind MethodHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeAnyu Peibo CapsuleDepressionRandomized controlled trials

Identifiers

PMID34479619
PMCPMC8414707

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.