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 years lost to disability worldwide. Anyu Peibo Capsule has been shown be effective and safe in phase II trials. Methods This clinical study a multi-center, randomized, double-blinded, placebo-controlled, parallel-group, III trial China. The aim test whether administration compared placebo improves outcomes adults (aged 18 65 years) with MDD. Patients will receive an 8-week treatment 1.6 g per day or placebo. primary outcome change from baseline total score for Montgomery-Asberg Depression Rating Scale at end treatment. Discussion aims provide pivotal evidence efficacy safety patients major disorder. Trial registration ClinicalTrials.gov NCT04210973 . Registered on December 26, 2019