A Phase 3 interventional study of Dextromethorphan and Bupropion Sustained-Release Tablets and Placebo in Major Depressive Disorder (MDD), sponsored by CSPC Ouyi Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by CSPC Ouyi Pharmaceutical Co., Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 3, Interventional, and Treatment
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 388 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →CSPC Ouyi Pharmaceutical Co., Ltd. is the lead sponsor of 30 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The researchers determined that it was 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Dextromethorphan and Bupropion Sustained-Release Tablets
Drug: Placebo
Oral dextromethorphan and bupropion sustained-release tablets, taken daily for 6 weeks.
Oral placebo tablets, taken daily for 6 weeks.
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
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
Incidence of adve rse events
Unit: % (proportion of participants experiencing adverse events to the total number of enrolled participants)
Time frame: Within 7 weeks
Incidence of serious adverse events
Unit: % (proportion of participants experiencing serious adverse events to the total number of enrolled participants)
Time frame: 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
Time frame: 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.
Time frame: 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).) o Unit: % (proportion of participants with abnormal ECG parameters to the total number of enrolled participants)
Time frame: Within 7 weeks
Proportion of participants with significant abnormalities in laboratory test results
o Unit: % (proportion of participants with significant laboratory test abnormalities to the total number of enrolled participants)
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.
* 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.
Time frame: 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.)
Time frame: 7 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CSPC Ouyi Pharmaceutical Co., Ltd. →