Major Depressive Disorder (MDD)Phase 3NCT06958692
A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder
A Phase 3 study testing Dextromethorphan and Bupropion Sustained-Release Tablets in people with Major Depressive Disorder (MDD), run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Dextromethorphan and Bupropion Sustained-Release Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2025to 30 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100088
Gang Wang, Ph.D, 86-010-86430066, adyywmb@126.com
About this study
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
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)
- Being tested
- Dextromethorphan and Bupropion Sustained-Release Tablets, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dextromethorphan and Bupropion | Experimental | Not described Receives: Drug: Dextromethorphan and Bupropion Sustained-Release Tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
CGI-I score (Week 1, Week 2, Week 3, Week 4, Week 6)
CGI-I：Clinical Global Impressions - Improvement. The minimum CGI-I score is 1, 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.
Measured: 1，2，3，4，6 weeks
Changes in CGI-S score from baseline to week 6
CGI-S（Clinical Global Impressions-Severity）: The minimum CGI-S score is 0, and the maximum score is 7. The lower the score, the closer the patient's condition is to the normal state, while the higher the score, the more severe the condition.
Measured: 6 weeks
Change in QIDS-SR-16 score from baseline to Week 6
QIDS-SR-16（Quick Inventory of Depressive Symptomatology - Self-Report, 16-Item）：The minimum QIDS-SR-16 score is 0, and the maximum score is 27. The lower the score, the milder the depressive symptoms are, while the higher the score, the more severe the depressive symptoms are.
Measured: 6 weeks
Change in SDS score from baseline to Week 6
SDS（Self-Rating Depression Scale）：The minimum SDS score is 0, and the maximum score is 30. In the assessment, the lower the standard score, the milder the depressive state, and vice versa.
Measured: 6 weeks
Incidence of adve rse events
Unit: % (proportion of participants experiencing adverse events to the total number of enrolled participants)
Measured: Within 7 weeks
Incidence of serious adverse events
Unit: % (proportion of participants experiencing serious adverse events to the total number of enrolled participants)
Measured: Within 7 weeks
Proportion of participants with significant abnormalities in vital signs
Unit: % (proportion of participants with significant vital sign abnormalities to the total number of enrolled participants)
- Vital signs include:
- Body temperature (axillary): ℃ (Celsius)
- Respiration: times/minute
- Pulse: times/minute
- Sitting blood pressure: mmHg
Measured: Within 7 weeks
Proportion of participants with significant abnormalities in physical examination results
- Unit: % (proportion of participants with significant physical examination abnormalities to the total number of enrolled participants)
- Examination content includes: general condition, head and face, skin system, lymph nodes, eyes, ear-nose-throat, oral cavity, thyroid, respiratory system, cardiovascular system, abdomen, musculoskeletal system, nervous system, etc.
Measured: Within 7 weeks
Proportion of participants with abnormal electrocardiogram (ECG) parameters
(The number of participants with significantly abnormal heart rate, respiratory rate (RR), PR interval, QRS duration, QT interval, and QTcF (in this study, the QT interval was corrected using Fridericia's formula).)
- Unit: % (proportion of participants with abnormal ECG parameters to the total number of enrolled participants)
Measured: Within 7 weeks
Proportion of participants with significant abnormalities in laboratory test results
- Unit: % (proportion of participants with significant laboratory test abnormalities to the total number of enrolled participants)
Measured: Within 7 weeks
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.
- Unit: % (proportion of participants with suicidal ideation or behavior to the total number of enrolled participants)
- C-SSRS is a questionnaire used to evaluate participants' suicidal ideation and behavior, systematically assessing participants' suicidal status from three dimensions: suicidal ideation, intensity of ideation, and suicidal behavior.
Measured: Within 7 weeks
Withdrawal responses as assessed by the PWC-20
（Physician Withdrawal Checklist - 20）scale(The minimum PWC-20 score is 0, and the maximum score is 60. The higher the score, the more severe the condition.)
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start11 Apr 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958692
- Sponsor's protocol ID
- SYH9052-002
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06958692
- Acronym / sponsor ID
- SYH9052-002
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Dextromethorphan and Bupropion | Experimental | Drug: Dextromethorphan and Bupropion Sustained-Release Tablets |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextromethorphan and Bupropion Sustained-Release TabletsOral dextromethorphan and bupropion sustained-release tablets, taken daily for 6 weeks. | Drug | Dextromethorphan and Bupropion |
| PlaceboOral placebo tablets, taken daily for 6 weeks. | Drug | Placebo |
Primary outcome
Change in MADRS Total Score From Baseline to Week 6
Time frame: 6 weeks
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.
16 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)
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)
Time frame: 6 weeks
Proportion of participants with a ≥ 30% improvement in total MADRS scores from baseline at week 6 after administration
Time frame: 6 weeks
PGI-I score at week 6 after administration
Time frame: 6 weeks
CGI-I score (Week 1, Week 2, Week 3, Week 4, Week 6)
Time frame: 1，2，3，4，6 weeks
Changes in CGI-S score from baseline to week 6
Time frame: 6 weeks
Change in QIDS-SR-16 score from baseline to Week 6
Time frame: 6 weeks
Change in SDS score from baseline to Week 6
Time frame: 6 weeks
Incidence of adve rse events
Time frame: Within 7 weeks
Incidence of serious adverse events
Time frame: Within 7 weeks
Proportion of participants with significant abnormalities in vital signs
Time frame: Within 7 weeks
Proportion of participants with significant abnormalities in physical examination results
Time frame: Within 7 weeks
Proportion of participants with abnormal electrocardiogram (ECG) parameters
Time frame: Within 7 weeks
Proportion of participants with significant abnormalities in laboratory test results
Time frame: Within 7 weeks
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.
Time frame: Within 7 weeks
Withdrawal responses as assessed by the PWC-20
Time frame: 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dextromethorphan and Bupropion Sustained-Release Tablets in people with Major Depressive Disorder (MDD), run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MADRS Total Score From Baseline to Week 6 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.