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

NCT06958692 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2025-05-06

No results posted yet for this study

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.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

DRUG

Dextromethorphan and Bupropion Sustained-Release Tablets

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

DRUG

Placebo

Oral placebo tablets, taken daily for 6 weeks.

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-11
Primary Completion
2026-09-30
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06958692 on ClinicalTrials.gov