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

NCT ID: NCT06958692

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-11
• Study Completion Date: 2026-12-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dextromethorphan and Bupropion

Group Type: EXPERIMENTAL

Dextromethorphan and Bupropion Sustained-Release Tablets

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo tablets, taken daily for 6 weeks.

Interventions

Dextromethorphan and Bupropion Sustained-Release Tablets

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

Intervention Type: DRUG

Placebo

Oral placebo tablets, taken daily for 6 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female, Age 18 - 65, inclusive

2. Currently meets DSM-5 diagnosis of MDD without psychotic features, Current major depressive episode of at least 4 weeks in duration at screening

3. Identified as MDD by Mini-international Neuropsychiatric interview (M.I.N.I.)

4. MADRS score ≥25 and CGI-S ≥4 at screening and baseline

5. The results of physical examination and laboratory tests during the screening period meet the test requirements

6. Body Mass Index between 18 and 40 kg/m2, inclusive

7. For male subjects, use of an adequate method of birth control by the subject and by female sexual partners

Exclusion Criteria

• 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.

3. Hospitalization in a psychiatric hospital during a current depressive episode 4. There is a clinically significant risk of suicide or self-harm and harm to others 5. Screening patients tested positive for substance abuse 6. In the investigator's judgment, there are any clinically significant oncology, hematology, or internal diseases that are not suitable for entry into the study Secretory/metabolic, cardiovascular, respiratory, kidney, liver, gastrointestinal, infectious or nervous system fever Or suffer from an unstable or progressive chronic disease 7. hypertension 8. Hypothyroidism or hyperthyroidism, except for the following cases: receiving stable medication with no change in dose for at least 1 month before screening (serum TSH must be > 0.75×LLN（ Lower Limit of Normal ） and < 1.25×ULN（Upper Limit of Normal ）) 9 Bupropion, dextromethorphan, opioids (such as codeine), or any of the study drugs Allergic to other ingredients 10. Presence of a history of intolerance to bupropion or dextromethorphan 11. People living with HIV, or testing positive for HIV during screening 12. Screening period hepatitis virology test positive 13. Liver enzyme test results during the screening period (total bilirubin, aspartate aminotransferase and/or alanine aminotransferase) > 2.0 × ULN 14. According to the investigator's judgment, other conditions are not suitable for participating in this clinical study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@cspc.cn

86-0311-69085587

Facility Contacts

Gang Wang, Ph.D

Role: primary

adyywmb@126.com

86-010-86430066

Other Identifiers

SYH9052-002

Identifier Type: -

Identifier Source: org_study_id