Trial · NCT06958692
A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder
NCT06958692, Phase 3, Recruiting, CSPC Ouyi Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder. Trials, record NCT06958692. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06958692
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder
- NCT number
- NCT06958692
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 388 participants, estimated
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Conditions
- Major Depressive Disorder (MDD)
- Interventions
- Dextromethorphan and Bupropion Sustained-Release Tablets, Placebo
- First posted
- 2025-05-06
- Last updated
- 2025-05-06
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in MADRS Total Score From Baseline to Week 6 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | Proportion of participants with a ≥ 30% improvement in total MADRS scores from baseline at week 6 after administration | 6 weeks | 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. |
| Secondary | PGI-I score at week 6 after administration | 6 weeks | （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. |
| Secondary | CGI-I score (Week 1, Week 2, Week 3, Week 4, Week 6) | 1，2，3，4，6 weeks | 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. |
| Secondary | Changes in CGI-S score from baseline to week 6 | 6 weeks | 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. |
| Secondary | Change in QIDS-SR-16 score from baseline to Week 6 | 6 weeks | 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. |
| Secondary | Change in SDS score from baseline to Week 6 | 6 weeks | 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. |
| Secondary | Incidence of adve rse events | Within 7 weeks | Unit: % (proportion of participants experiencing adverse events to the total number of enrolled participants) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06958692
GET https://conductscience.org/api/trials/v1/NCT06958692/registered