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

Abstract Background: Major depressive disorder is the second leading cause of year lost to disability worldwide. Anyu Peibo Capsule was shown to have certain effective and favorable safety in phase II trials.Methods: The clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel groups phase Ⅲ trail of Anyu Peibo Capsule in China, to aim whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcome in adults (18 years to 65 years) with MDD. The subjects will receive 8-week treatment with Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change of total score from baseline to the end of week 8 in Montgomery Asberg Depression Rating Scale.Discussion: The trial aims to provide pivotal evidence on the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder. Trial registration: ClinicalTrials.gov, NCT04210973. Registered on December 26, 2019. https://www.clinicaltrials.gov/ct2/show/NCT04210973 Protocol version 1.2 from 29 August 2019.