Trial · NCT06278038
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Snaith-Hamilton Pleasure Scale (SHAPS) Total Score | Baseline and the end of week 8 | The SHAPS is a well-validated 14-item self-report questionnaire commonly used to assess anhedonia. Each item on the SHAPS is worded so that higher scores indicate greater pleasure capacity. A total score can be derived by summing the responses to each item. Each item is rated as either 0 or 1, for a total score between 0 and 14, with higher scores corresponding to higher levels of anhedonia. |
| Secondary | Snaith-Hamilton Pleasure Scale (SHAPS) Total Score | Baseline, the end of Week 2 and 4 | The SHAPS is a well-validated 14-item self-report questionnaire commonly used to assess anhedonia. Each item on the SHAPS is worded so that higher scores indicate greater pleasure capacity. A total score can be derived by summing the responses to each item. Each item is rated as either 0 or 1, for a total score between 0 and 14, with higher scores corresponding to higher levels of anhedonia. |
| Secondary | Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate | The end of Week 2, 4 and 8 | Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate(%) = (pre-treatment score - post-treatment score)/pre-treatment score ×100%. SHAPS Reductive Rate(%) ≥75% is recovery, 50% \~ 74% is significantly effective, 25% \~ 49% is effective, and \< 25% is ineffective. |
| Secondary | Dimensional Anhedonia Rating Scale (DARS) Score | Baseline, the end of Week 2, 4 and 8 | DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in major depressive disorder (MDD), and particularly to increase scale generalizability while maintaining specificity. Respondents provide their own examples of rewarding experiences across the domains of hobbies, social activities, food/drink, and sensory experience. Participants answer a set of standardized questions about desire, motivation, effort, and consummatory pleasure with a recall period of "right now" for the examples provided. The instrument is scored as a total sum of all items (range 0-68) with higher scores reflecting increased motivation, effort and pleasure (that is, less anhedonia). |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Score | Baseline, the end of Week 2, 4 and 8 | The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. |
| Secondary | 17-item Hamilton Depression Rating Scale (HAM-D17) Score | Baseline, the end of Week 2, 4 and 8 | HAM-D17 has been the gold standard for the assessment of depression. The score needs to be based on clinical interviews, and the time frame of the assessment is usually the situation in the previous week. Most items use a 5-point scale of 0 to 4. The standard of each level is: 0 indicates none, 1 indicates mild, 2 indicates moderate, 3 indicates severe, and 4 indicates extremely severe. A few items adopt the 3-level scoring method with 0\~2 points, and the grading standard is: 0 indicates none, 1 indicates mild to moderate and 2 indicates severe. |
| Secondary | Sheehan Disability Scale (SDS) Score | Baseline, the end of Week 2, 4 and 8 | SDS is composed of three self-rating dimensions, which assess functional status in work, social life/leisure activities, and family life/family responsibilities. Each dimension is scored on a scale of 0 to 10, with 1 to 3 indicating mild impairment, 4 to 6 indicating moderate impairment, 7 to 9 indicating significant impairment, and 10 indicating extreme severity. The three dimensions can also be added together to reflect the overall functional deficiency. The score ranges from 0 to 30, with 0 indicating no damage and 30 indicating significant damage. |
| Secondary | Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score | Baseline, the end of Week 2, 4 and 8 | Q-LES-Q-SF consists of 16 self-rated items. Each item is divided into five grades: 1 indicates very dissatisfied, 2 indicates dissatisfied, 3 indicates average, 4 indicates satisfied, and 5 indicates very satisfied. The higher the score, the better the happiness and quality of life satisfaction of the subjects. The first 14 items are used to generate an overall score, while the remaining 2 items are individual items that measure satisfaction and overall quality of life related to the study drug. |
| Other | Treatment Emergent Symptom Scale (TESS) Score | The end of Week 2, 4 and 8 | Treatment Emergent Symptom Scale was developed by The National Institute of Mental Health (NIMH) in the USA in 1973. It is a safety assessment tool after treatment of psychiatric diseases. Evaluation is based on patient reports, physical examination results, and laboratory reports, and some items should also be consulted with the patient's family. Severity item is scored from 0 (not present) to 4 (severe). Higher scores represent a more severe condition. |
| Other | Arizona Sexual Experience Scale (ASEX) Score | Baseline, the end of Week 2, 4 and 8 | ASEX is designed to assess aspects of psychotropic drug-induced sexual dysfunction: drive, arousal, penile erection/vaginal lubrication, ability to reach orgasm, and satisfaction from orgasm. The ASEX can be self- or clinician-administered. The 5 questions are rated using 6-point Likert-type scales with varying endpoints. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. |
| Other | Count of red blood cell in blood | Baseline, the end of Week 8 | To analysis whether count of red blood cell in blood show any significant trend with time changes. |
| Other | Count of white blood cell in blood | Baseline, the end of Week 8 | To analysis whether count of white blood cell in blood show any significant trend with time changes. |
| Other | Count of platelet in blood | Baseline, the end of Week 8 | To analysis whether count of platelet in blood show any significant trend with time changes. |
| Other | Concentration of hemoglobin in blood | Baseline, the end of Week 8 | To analysis whether concentration of hemoglobin in blood show any significant trend with time changes. |
| Other | Concentration of alanine aminotransferase in blood | Baseline, the end of Week 8 | To analysis whether concentration of alanine aminotransferase in blood show any significant trend with time changes. |
| Other | Concentration of aspartate aminotransferase in blood | Baseline, the end of Week 8 | To analysis whether concentration of aspartate aminotransferase in blood show any significant trend with time changes. |
| Other | Concentration of gamma-glutamyltransferase in blood | Baseline, the end of Week 8 | To analysis whether concentration of gamma-glutamyltransferase in blood show any significant trend with time changes. |
| Other | Concentration of blood glucose in blood | Baseline, the end of Week 8 | To analysis whether concentration of blood glucose in blood show any significant trend with time changes. |
| Other | Concentration of serum creatinine in blood | Baseline, the end of Week 8 | To analysis whether concentration of serum creatinine in blood show any significant trend with time changes. |
| Other | Concentration of urea in blood | Baseline, the end of Week 8 | To analysis whether concentration of urea in blood show any significant trend with time changes. |
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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