Clinical trial NCT06958692: A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Adult Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-06
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in MADRS Total Score From Baseline to Week 6
timeFrame: 6 weeks
Secondary outcomes:
measure: 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)
timeFrame: 2 weeks
measure: 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)
timeFrame: 6 weeks
measure: Proportion of participants with a ≥ 30% improvement in total MADRS scores from baseline at week 6 after administration
timeFrame: 6 weeks
measure: PGI-I score at week 6 after administration
timeFrame: 6 weeks
measure: CGI-I score (Week 1, Week 2, Week 3, Week 4, Week 6)
timeFrame: 1，2，3，4，6 weeks
measure: Changes in CGI-S score from baseline to week 6
timeFrame: 6 weeks
measure: Change in QIDS-SR-16 score from baseline to Week 6
timeFrame: 6 weeks
measure: Change in SDS score from baseline to Week 6
timeFrame: 6 weeks
measure: Incidence of adve rse events
timeFrame: Within 7 weeks
measure: Incidence of serious adverse events
timeFrame: Within 7 weeks
measure: Proportion of participants with significant abnormalities in vital signs
timeFrame: Within 7 weeks
measure: Proportion of participants with significant abnormalities in physical examination results
timeFrame: Within 7 weeks
measure: Proportion of participants with abnormal electrocardiogram (ECG) parameters
timeFrame: Within 7 weeks
measure: Proportion of participants with significant abnormalities in laboratory test results
timeFrame: Within 7 weeks
measure: Incidence of suicidal ideation and behavior assessed by C-SSRS（Columbia Suicide Severity Rating Scale），It can comprehensively assess the individual's suicide risk level. The higher the score, the higher the suicide risk.
timeFrame: Within 7 weeks
measure: Withdrawal responses as assessed by the PWC-20
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital Affiliated to Capital Medical University
state: Beijing
Study officials:
References: