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

Phase 3RecruitingNCT06958692

CSPC Ouyi Pharmaceutical Co., Ltd.388 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

388

Conditions

Major Depressive Disorder (MDD)

Interventions

Dextromethorphan and Bupropion Sustained-Release TabletsDRUG

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

PlaceboDRUG

Oral placebo tablets, taken daily for 6 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks

Secondary Outcomes

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)

The minimum MARDS score is 0, and the maximum score is 60. The higher the total score, the more severe the patient's depressive symptoms are.

Time frame: 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)

The minimum MARDS score is 0, and the maximum score is 60. The higher the total score, the more severe the patient's depressive symptoms are.

Time frame: 6 weeks

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

The minimum MARDS score is 0, and the maximum score is 60. The higher the total score, the more severe the patient's depressive symptoms are.

Time frame: 6 weeks

PGI-I score at week 6 after administration

（PGI-I：Patient Global Impression - Improvement）The minimum PGI-I score is 0, and the maximum score is 7 The higher the score, the more severe the degree of deterioration, while the lower the score, the better the improvement.

Time frame: 6 weeks

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

Central Contacts

Clinical Trials Information Group officer

CONTACT

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

Data from ClinicalTrials.gov

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