Study Design and Methodology
The study was a Phase IIb multicenter, randomized, double-blind, placebo-controlled trial conducted at nine centers in China, including the Shanghai Mental Health Center. It aimed to evaluate the efficacy and safety of Anyu Peibo capsules in patients with Major Depressive Disorder (MDD). The trial included a 1-week screening and washout period, followed by a 6-week double-blind treatment period and a 1-week double-blind down-taper period. Patients were randomized to receive either Anyu Peibo capsules (0.8 g twice daily) or a placebo.
Patient Selection
Adult patients aged 18 to 65 years diagnosed with MDD according to the DSM-5 criteria were eligible. Inclusion criteria required a MADRS total score ≥24 points and a HAMD-17 total score ≥18 points at screening and baseline. Exclusion criteria included a history of suicide attempts, current psychiatric diagnoses other than depression, and certain medical conditions.
Outcome Measures
The primary outcome was the change in the MADRS total score from baseline to week 6. Secondary outcomes included clinical response and remission rates according to MADRS and HAMD-17 scores, changes in CGI-S and CGI-I scale scores, and changes in the HAMA total score.
Results
While the primary outcome did not show a significant difference between the Anyu Peibo capsule and placebo groups, secondary outcomes indicated potential benefits of Anyu Peibo capsules. Significant improvements were observed in HAMD-17 scores and reductions in the HAMA total score after 6 weeks of treatment. The treatment was safe and well-tolerated, with the most common adverse events being upper respiratory tract infection, nausea, constipation, and diarrhea.
Discussion
The study suggests that Anyu Peibo capsules may be safe and have the potential to reduce depressive symptoms in patients with MDD. However, the primary outcome was negative, and further validation through subsequent studies is necessary. The phase IIb trial results provide essential research evidence for initiating phase III clinical trials, aiming to better understand the drug's adverse reactions and optimize trial design.
