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] The Efficacy of Agomelatine in Elderly Patients With Recurrent Major Depressive Disorder: A Placebo-Controlled Study
    Heun, Reinhard
    Ahokas, Antti
    Boyer, Patrice
    Gimenez-Montesinos, Natalia
    Pontes-Soares, Fernando
    Olivier, Valerie
    JOURNAL OF CLINICAL PSYCHIATRY, 2013, 74 (06) : 587 - 594
  • [32] Agomelatine in the Treatment of Major Depressive Disorder: An 8-Week, Multicenter, Randomized, Placebo-Controlled Trial
    Stahl, Stephen M.
    Fava, Maurizio
    Trivedi, Madhukar H.
    Caputo, Angelika
    Shah, Amy
    Post, Anke
    JOURNAL OF CLINICAL PSYCHIATRY, 2010, 71 (05) : 616 - 626
  • [33] EFFICACY AND TOLERABILITY OF EXTENDED RELEASE QUETIAPINE FUMARATE MONOTHERAPY AS MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER: A RANDOMIZED, PLACEBO-CONTROLLED TRIAL
    Liebowitz, Michael
    Lam, Raymond W.
    Lepola, Ulla
    Datto, Catherine
    Sweitzer, Dennis
    Eriksson, Hans
    DEPRESSION AND ANXIETY, 2010, 27 (10) : 964 - 976
  • [34] A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder
    Septien-Velez, Lucia
    Pitrosky, Bruno
    Padmanabhan, Sudharshan Krishna
    Germain, Jean-Michel
    Tourian, Karen A.
    INTERNATIONAL CLINICAL PSYCHOPHARMACOLOGY, 2007, 22 (06) : 338 - 347
  • [35] The efficacy and safety of sulforaphane as an adjuvant in the treatment of bipolar depressive disorder Study protocol for a randomized, double-blinded, placebo-controlled, parallel-group clinical trial
    Wu, Congchong
    Chen, Xingyang
    Lai, Jianbo
    Xu, Yi
    Hu, Shaohua
    MEDICINE, 2020, 99 (26) : E20981
  • [36] A Phase III Prospective Active and Placebo-Controlled Randomized Trial of Vilazodone in the Treatment of Major Depressive Disorder
    Sinha, Shubhadeep
    Chary, Sreenivasa
    Thakur, Pankaj
    Talluri, Leela
    Reddy, Mohan
    Verma, Kamal K.
    Saha, Pradeep
    Gupta, Vijaya B.
    Ramaiah, Kaja A.
    Khanum, Siquafa Z.
    CUREUS JOURNAL OF MEDICAL SCIENCE, 2021, 13 (07)
  • [37] A Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible-Dose Desvenlafaxine Treatment in Outpatients with Major Depressive Disorder
    Feiger, Alan D.
    Tourian, Karen A.
    Rosas, Gregory R.
    Padmanabhan, S. Krishna
    CNS SPECTRUMS, 2009, 14 (01) : 41 - 50
  • [38] Evaluation of the efficacy and safety of Yukwool-tang for major depressive disorder in women: A randomized, double blinded, placebo-controlled, parallel trial
    Seo, Young Kyung
    Choi, Sunyoung
    Choi, Youngeun
    Choi, Sungmin
    Kwon, Ojin
    Kim, Hyungjun
    Jung, In Chul
    MEDICINE, 2024, 103 (21) : E38208
  • [39] Efficacy and safety of propranolol for treatment of temporomandibular disorder pain: a randomized, placebo-controlled clinical trial
    Tchivileva, Inna E.
    Hadgraft, Holly
    Lim, Pei Feng
    Di Giosia, Massimiliano
    Ribeiro-Dasilva, Margarete
    Campbell, John H.
    Willis, Janet
    James, Robert
    Herman-Giddens, Marcus
    Fillingim, Roger B.
    Ohrbach, Richard
    Arbes, Samuel J.
    Slade, Gary D.
    PAIN, 2020, 161 (08) : 1755 - 1767
  • [40] Efficacy and safety of add-on sarcosine in patients with major depressive disorder: A randomized controlled trial
    Padhan, Milan
    Mohapatra, Debadatta
    Mishra, Biswa Ranjan
    Maiti, Rituparna
    Jena, Monalisa
    JOURNAL OF PSYCHIATRIC RESEARCH, 2024, 178 : 298 - 304
12345