RecruitingPhase 3NCT06958692

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Adult Patients With Major Depressive Disorder


Sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Enrollment

388 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination pill containing dextromethorphan (commonly found in cough medicine) and bupropion (an antidepressant) for people with major depressive disorder (MDD). This combination works on the brain in a different way than most current antidepressants and may help people who haven't responded well to other treatments. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with major depressive disorder (without psychosis) - Your current depressive episode has lasted at least 4 weeks - Your depression is at least moderately severe based on clinical assessments - You are not currently responding well to your existing antidepressant **You may NOT be eligible if...** - You have a history of bipolar disorder, schizophrenia, or psychosis - You have active thoughts of suicide with a plan - You have a history of seizures or eating disorders (anorexia/bulimia) - You are pregnant or breastfeeding - You are currently taking certain medications that interact with these drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDextromethorphan and Bupropion Sustained-Release Tablets

Oral dextromethorphan and bupropion sustained-release tablets, taken daily for 6 weeks.

DRUGPlacebo

Oral placebo tablets, taken daily for 6 weeks.


Locations(1)

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

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NCT06958692


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