Trial · NCT06270433
Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder
NCT06270433, Not applicable, Unknown, Jiangsu Province Nanjing Brain Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder. Trials, record NCT06270433. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06270433
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder
- NCT number
- NCT06270433
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Conditions
- Anhedonia
- Interventions
- Toludesvenlafaxine hydrochloride sustained-release tablets, Desvenlafaxine succinate sustained-release tablets
- First posted
- 2024-02-21
- Last updated
- 2024-04-29
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
| 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. |
| Secondary | Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate | The end of Week 2, 4 and 8 | SHAPS Reductive Rate(%) = (pre-treatment score - post-treatment score)/pre-treatment score ×100%. |
| 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 | Rating Scale for Side Effects (SERS) Score | The end of Week 2, 4 and 8 | All items in SERS adopt 4-level scoring method ranging from 0 to 3 points, and the standard of each item is as follows :0 indicates none, 1 indicates mild, 2 indicates moderate and 3 indicates severe. Two evaluation scales are required for each symptom. The first is the spontaneous reporting of patients when answering questions. The second is what the evaluator observed. The evaluator needs to systematically ask about each symptom. |
| 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. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 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/NCT06270433
GET https://conductscience.org/api/trials/v1/NCT06270433/registered?page=2