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The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of major depression disorder compared to venlafaxine hydrochloride 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 venlafaxine hydrochloride 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toludesvenlafaxine hydrochloride sustained-release tablets treatment group | Experimental |
| |
| Venlafaxine hydrochloride sustained-release tablets treatment group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toludesvenlafaxine hydrochloride sustained-release tablets | Drug | 80 mg or 120 mg or 160 mg orally once daily dosing for 8 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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, with higher scores corresponding to higher levels of anhedonia. | Baseline and the end of week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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, with higher scores corresponding to higher levels of anhedonia. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Symptom Scale (TESS) Score | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| Venlafaxine hydrochloride sustained-release tablets | Drug | 75 mg or 150 mg or 225 mg orally once daily dosing for 8 weeks |
|
| Baseline, the end of Week 2 and 4 |
| Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate | 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. | 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). | 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. | 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. | 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. | 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. | Baseline, the end of Week 2, 4 and 8 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, the end of Week 8 |
| ECG QT Interval | To analysis whether ECG QT Interval of participants show any significant trend with time changes. | Baseline, the end of Week 8 |
| Changes in weight | To analysis whether weight of participants show any significant trend with time changes. | 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. | 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. | 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. | 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. | Baseline, the end of Week 2, 4 and 8 |