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

被引：1
作者：
Huang, Jingjing [1 ]
Yu, Yimin [1 ]
Jiang, Yi [2 ]
Chen, Wu [2 ]
Li, Yan [1 ]
Shen, Yifeng [1 ]
Zheng, Qingshan [3 ]
Li, Huafang [1 ]
机构：
[1] Shanghai Jiao Tong Univ, Shanghai Mental Hlth Ctr, Sch Med, 600 Wan Ping Nan Rd, Shanghai 200030, Peoples R China
[2] Su Zhou YiHua Biotechnol Co Ltd, Suzhou, Peoples R China
[3] Shanghai Univ Tradit Chinese Med, Shanghai, Peoples R China
来源：
TRIALS | 2021年 / 22卷 / 01期
关键词：
Depression; Anyu Peibo Capsule; Randomized controlled trials; MEDICINAL-PLANTS; GLOBAL IMPRESSION; SCALE; ANTIDEPRESSANT;
D O I：
10.1186/s13063-021-05550-9
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
Background: Major 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. Methods: This 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.
引用
收藏
页数：9
相关论文
共 50 条
  • [31] Efficacy and Safety of Cariprazine as Adjunctive Therapy in Major Depressive Disorder: A Double-blind, Placebo-controlled Study
    Fava, Maurizio
    Durgam, Suresh
    Mergel, Victor
    Earley, Willie
    Nemeth, Gyoergy
    Laszlovszky, Istvan
    [J]. NEUROPSYCHOPHARMACOLOGY, 2014, 39 : S352 - S353
  • [32] A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder
    Alvarez, Enric
    Perez, Victor
    Dragheim, Marianne
    Loft, Henrik
    Artigas, Francesc
    [J]. INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY, 2012, 15 (05) : 589 - 600
  • [33] Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in major depressive disorder: A placebo-controlled, randomized study
    Bortnick, Brian
    El-Khalili, Nizar
    Banov, Michael
    Adson, David
    Datto, Catherine
    Raines, Shane
    Earley, Willie
    Eriksson, Hans
    [J]. JOURNAL OF AFFECTIVE DISORDERS, 2011, 128 (1-2) : 83 - 94
  • [34] Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial
    Cezar Giosan
    Oana Cobeanu
    Cristina Mogoaşe
    Aurora Szentagotai
    Vlad Mureşan
    Rareș Boian
    [J]. Trials, 18
  • [35] Update on Randomized Placebo-Controlled Trials in the Past Decade for Treatment of Major Depressive Disorder in Child and Adolescent Patients: A Systematic Review
    Ignaszewski, Martha J.
    Waslick, Bruce
    [J]. JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY, 2018, 28 (10) : 668 - 675
  • [36] Cilostazol as an adjunctive treatment in major depressive disorder: a pilot randomized, double-blind, and placebo-controlled clinical trial
    Khadivi, Aida
    Shobeiri, Parnian
    Momtazmaneh, Sara
    Samsami, Farhaneh-Sadat
    Shalbafan, Mohammadreza
    Shirazi, Elham
    Akhondzadeh, Shahin
    [J]. PSYCHOPHARMACOLOGY, 2022, 239 (02) : 551 - 559
  • [37] Electroacupuncture plus moxibustion therapy for patients with major depressive disorder: study protocol for a randomized controlled trial
    Kim, Mikyung
    Choi, Eun-Ji
    Kim, Sung-Phil
    Kim, Jung-Eun
    Park, Hyo-Ju
    Kim, Ae-Ran
    Seo, Bok-Nam
    Kwon, O-Jin
    Cho, Jung Hyo
    Chung, Sun-Yong
    Kim, Joo-Hee
    [J]. TRIALS, 2017, 18
  • [38] Electroacupuncture plus moxibustion therapy for patients with major depressive disorder: study protocol for a randomized controlled trial
    Mikyung Kim
    Eun-Ji Choi
    Sung-Phil Kim
    Jung-Eun Kim
    Hyo-Ju Park
    Ae-Ran Kim
    Bok-Nam Seo
    O-Jin Kwon
    Jung Hyo Cho
    Sun-Yong Chung
    Joo-Hee Kim
    [J]. Trials, 18
  • [39] The efficacy and safety of bupropion sustained-release formulation for the treatment of major depressive disorder: a multi-center, randomized, double-blind, placebo-controlled study in Asian patients
    Koshino, Yoshifumi
    Bahk, Won-Myong
    Sakai, Hideaki
    Kobayashi, Takayuki
    [J]. NEUROPSYCHIATRIC DISEASE AND TREATMENT, 2013, 9 : 1273 - 1280
  • [40] Safety and Efficacy of Mirtazapine Compared to Sertraline in Hemodialysis Patients with Major Depressive Disorder: A Randomized Controlled Clinical Trial
    Hosseini, Seyed Mehdi
    Shariati, Shadieh
    Gholyaf, Mahmoud
    Bakhtiari, Kimia
    Zamanirafe, Maryam
    Ahmadpanah, Mohammad
    Mehrpooya, Maryam
    [J]. CURRENT PSYCHIATRY RESEARCH AND REVIEWS, 2024,
12345