An interventional study of Toludesvenlafaxine hydrochloride sustained-release tablets and Desvenlafaxine succinate sustained-release tablets in Anhedonia, sponsored by Jiangsu Province Nanjing Brain Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Jiangsu Province Nanjing Brain Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of anhedonia in patients with major depression disorder compared to desvenlafaxine succinate sustained-release tablets, to provide evidence-based basis for clinical rational drug use.
The study included 80 patients with major depression disorder (aged 18 to 65 years) who meet the diagnostic criteria for depression in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Eligible patients were randomly assigned (1:1) to 8-week treatment with toludesvenlafaxine hydrochloride sustained-release tablets (n=40) or desvenlafaxine succinate sustained-release tablets(n=40), followed up at period of enrollment as baseline and at the end of 2th, 4th and 8th weeks. Adverse events were recorded.
119 studies on the registry are indexed under Anhedonia; 44 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 99 interventional studies indexed under Anhedonia.
Browse Anhedonia studies →Jiangsu Province Nanjing Brain Hospital is the lead sponsor of 22 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Drug: Toludesvenlafaxine hydrochloride sustained-release tablets
Drug: Desvenlafaxine succinate sustained-release tablets
80 mg or 120 mg or 160 mg orally once daily dosing for 8 weeks
50 mg orally once daily dosing for 8 weeks
Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
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
Time frame: Baseline and the end of week 8
Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
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.
Time frame: Baseline, the end of Week 2 and 4
Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate
SHAPS Reductive Rate(%) = (pre-treatment score - post-treatment score)/pre-treatment score ×100%.
Time frame: The end of Week 2, 4 and 8
Dimensional Anhedonia Rating Scale (DARS) Score
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).
Time frame: Baseline, the end of Week 2, 4 and 8
Montgomery-Asberg Depression Rating Scale (MADRS) Score
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.
Time frame: Baseline, the end of Week 2, 4 and 8
17-item Hamilton Depression Rating Scale (HAM-D17) Score
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.
Time frame: Baseline, the end of Week 2, 4 and 8
Sheehan Disability Scale (SDS) Score
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.
Time frame: Baseline, the end of Week 2, 4 and 8
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score
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.
Time frame: Baseline, the end of Week 2, 4 and 8
Rating Scale for Side Effects (SERS) Score
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.
Time frame: The end of Week 2, 4 and 8
Arizona Sexual Experience Scale (ASEX) Score
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.
Time frame: Baseline, the end of Week 2, 4 and 8
Count of red blood cell in blood
To analysis whether count of red blood cell in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Count of white blood cell in blood
To analysis whether count of white blood cell in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Count of platelet in blood
To analysis whether count of platelet in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of hemoglobin in blood
To analysis whether concentration of hemoglobin in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of alanine aminotransferase in blood
To analysis whether concentration of alanine aminotransferase in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of aspartate aminotransferase in blood
To analysis whether concentration of aspartate aminotransferase in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of gamma-glutamyltransferase in blood
To analysis whether concentration of gamma-glutamyltransferase in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of blood glucose in blood
To analysis whether concentration of blood glucose in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of serum creatinine in blood
To analysis whether concentration of serum creatinine in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of urea in blood
To analysis whether concentration of urea in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of total cholesterol in blood
To analysis whether concentration of total cholesterol in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of high density lipoprotein in blood
To analysis whether concentration of high density lipoprotein in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of low density lipoprotein in blood
To analysis whether concentration of low density lipoprotein in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of triglyceride in blood
To analysis whether concentration of triglyceride in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of thyroid-stimulating hormone in blood
To analysis whether concentration of thyroid-stimulating hormone in blood show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of protein in urine
To analysis whether concentration of protein in urine show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Concentration of sugar in urine
To analysis whether concentration of sugar in urine show any significant trend with time changes
Time frame: Baseline, the end of Week 8
Count of white blood cell in urine
To analysis whether count of white blood cell in urine show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Count of red blood cell in urine
To analysis whether count of red blood cell in urine show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
ECG QT Interval
To analysis whether ECG QT Interval of participants show any significant trend with time changes.
Time frame: Baseline, the end of Week 8
Changes in weight
To analysis whether weight of participants show any significant trend with time changes.
Time frame: Baseline, the end of Week 2, 4 and 8
Changes in pulse
To analysis whether pulse of participants show any significant trend with time changes.
Time frame: Baseline, the end of Week 2, 4 and 8
Changes in both systolic and diastolic blood pressure
To analysis whether blood pressure including systolic blood pressure and diastolic blood pressure of participants show any significant trend with time changes.
Time frame: Baseline, the end of Week 2, 4 and 8
Changes in respiration rate
To analysis whether respiration rate of participants show any significant trend with time changes.
Time frame: Baseline, the end of Week 2, 4 and 8
Changes in armpit temperature
To analysis whether armpit temperature of participants show any significant trend with time changes.
Time frame: Baseline, the end of Week 2, 4 and 8
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Jiangsu Province Nanjing Brain Hospital