biostudies-literatureHuang JShanghai Clinical Research Center for Mental HealthChina National Major Project for IND585https://www.ebi.ac.uk/biostudies/studies/S-EPMC8414707biostudies-literatureUnknown22(1)<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Discussion</h4>The trial aims to prTrialsThe 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.PMC841470719MC19111002018ZX09734-005Jiang YLi HLi YHuang JChen WZheng QShen YYu YfalseThe 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.<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Discussion</h4>The trial aims to pr2021-01-01T00:00:00Z2021 Sep2025-04-29T10:08:16.269Z2022-02-11T10:51:59.824ZS-EPMC84147073447961910.1186/s13063-021-05550-9