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

NCT06958692 | Recruiting Phase 3

• 1 other identifier: SYH9052-002
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (16)

• 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)

  2 weeks

• 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)

  6 weeks

• Proportion of participants with a ≥ 30% improvement in total MADRS scores from baseline at week 6 after administration

  6 weeks

• PGI-I score at week 6 after administration

  6 weeks

• CGI-I score (Week 1, Week 2, Week 3, Week 4, Week 6)

  1，2，3，4，6 weeks

Study Arms (2)

Dextromethorphan and Bupropion

EXPERIMENTAL

Drug: Dextromethorphan and Bupropion Sustained-Release Tablets

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dextromethorphan and Bupropion Sustained-Release Tablets DRUG

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

Dextromethorphan and Bupropion

Placebo DRUG

Oral placebo tablets, taken daily for 6 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The results of physical examination and laboratory tests during the screening period meet the test requirements
• Body Mass Index between 18 and 40 kg/m2, inclusive
• For male subjects, use of an adequate method of birth control by the subject and by female sexual partners

You may not qualify if:

• \. 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.
• \. 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

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100088, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: May 6, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-04

Locations

CN (1)