Phase 3 Study of Dextromethorphan and Bupropion Tablets to Treat Adults With Major Depressive Disorder

What this Trial Is About

Researchers are evaluating the use of dextromethorphan and bupropion sustained-release tablets in adult patients with major depressive disorder MDD. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness and safety of these tablets in Chinese adults diagnosed with MDD, a condition characterized by a major depressive episode lasting at least 4 weeks. The study is sponsored by CSPC Ouyi Pharmaceutical Co., Ltd. Participants will be randomly assigned to receive either oral dextromethorphan and bupropion sustained-release tablets or a placebo, taken daily for 6 weeks. The study includes careful monitoring and assessments during this treatment period. The primary outcome measured is the change in the Montgomery-sberg Depression Rating Scale MADRS total score from baseline to week 6. Secondary outcomes include treatment response rates, clinical cure rates, various depression and functioning scores, and safety outcomes such as adverse events and laboratory test abnormalities. During the study, participants will undergo evaluations including physical exams, laboratory tests, and psychiatric scales at different time points up to 7 weeks. Safety will be monitored through reports of adverse events, vital signs, ECGs, and suicidal ideation assessments using the Columbia Suicide Severity Rating Scale C-SSRS. Participants response to treatment and withdrawal symptoms will also be tracked. Overall, the study duration for each participant is about 6 to 7 weeks, with follow-up assessments to evaluate treatment effects and safety.

A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder