Trial · NCT06958692
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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) |
| Secondary | Incidence of serious adverse events | Within 7 weeks | Unit: % (proportion of participants experiencing serious adverse events to the total number of enrolled participants) |
| Secondary | Proportion of participants with significant abnormalities in vital signs | Within 7 weeks | 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 |
| Secondary | Proportion of participants with significant abnormalities in physical examination results | Within 7 weeks | * 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. |
| Secondary | Proportion of participants with abnormal electrocardiogram (ECG) parameters | Within 7 weeks | (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) |
| Secondary | Proportion of participants with significant abnormalities in laboratory test results | Within 7 weeks | o Unit: % (proportion of participants with significant laboratory test abnormalities to the total number of enrolled participants) |
| Secondary | 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. | Within 7 weeks | * 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. |
| Secondary | Withdrawal responses as assessed by the PWC-20 | 7 weeks | （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.) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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