A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial, aim to evaluate the efficacy and safety of dextromethorphan and bupropion sustained-release tablets in Chinese adult patients with major depressive disorder.
Male or female, Age 18 - 65, inclusive
Currently meets DSM-5 diagnosis of MDD without psychotic features, Current major depressive episode of at least 4 weeks in duration at screening
Identified as MDD by Mini-international Neuropsychiatric interview (M.I.N.I.)
MADRS score ≥25 and CGI-S ≥4 at screening and baseline
1. The researchers determined that it was refractory depression [defined as in a current depressive episode or a previous depressive episode, After 2 or more antidepressants, a sufficient amount (in the maximum recommendation of the manual), a course of foot therapy (at least even Continued medication for 4-6 weeks) ineffective after treatment] 2. The MADRS score improved by ≥ 25% at baseline compared with the screening period.
Parallel
Dextromethorphan and Bupropion Sustained-Release Tablets
DrugOral dextromethorphan and bupropion sustained-release tablets, taken daily for 6 weeks.
Placebo
DrugOral placebo tablets, taken daily for 6 weeks.
Change in MADRS Total Score From Baseline to Week 6
The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
Treatment response rate (the proportion of participants whose total score on the Montgomery-Åsberg Depression Rating Scale (MADRS) has improved by ≥ 50% compared to the baseline at the 6th week after administration)
The minimum MARDS score is 0, and the maximum score is 60. The higher the total score, the more severe the patient's depressive symptoms are.
Clinical cure rate (the proportion of participants with a total score of the Montgomery-Åsberg Depression Rating Scale (MADRS) ≤ 10 at the 2nd week after administration)
The minimum MARDS score is 0, and the maximum score is 60. The higher the total score, the more severe the patient's depressive symptoms are.
Proportion of participants with a ≥ 30% improvement in total MADRS scores from baseline at week 6 after administration
The minimum MARDS score is 0, and the maximum score is 60. The higher the total score, the more severe the patient's depressive symptoms are.
PGI-I score at week 6 after administration
（PGI-I：Patient Global Impression - Improvement）The minimum PGI-I score is 0, and the maximum score is 7 The higher the score, the more severe the degree of deterioration, while the lower the score, the better the improvement.
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