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Completed

NCT Number: NCT06278038

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder

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.

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Key information

Conditions

Major Depression Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects meet the diagnostic criteria for major depression disorder in the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition (DSM-5);
  • Male or female aged ≥18 and ≤65 years;
  • Subjects who have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥18 points;
  • Subjects who have a total score of Snaith-Hamilton Pleasure Scale (SHARPS) ≥3 points;
  • Subjects voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

  • Allergic or known to be allergic to toludesvenlafaxine hydrochloride sustained-release tablets and venlafaxine hydrochloride sustained-release tablets;
  • Subjects have a severe self-injury/clear suicide attempt or behavior; Scores on HAM-D17 items factor 3 ≥3 points;
  • Subjects who meet the diagnostic criteria for any other psychotic disorders in DSM-5;
  • Subjects who meet the diagnostic criteria for substance disorders or alcohol abuse in DSM-5 (except for nicotine or caffeine) within the past six months;
  • Individuals with severe and unstable physical diseases such as cardiovascular disease, liver disease, kidney disease, blood disorders, and endocrine disorders;
  • Hypertensive patients with poor blood pressure control (systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg at screening);
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 times / creatinine (Cr) 1.2 times higher than the upper limit of normal at screening;
  • Electrocardiogram (ECG) abnormalities that are clinically significant at period of screening and that the investigator considers as inappropriate conditions for inclusion, such as QTc interval >450 ms in men and QTc interval >460 ms in female;
  • Subjects who received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within 3 months prior to screening;
  • Subjects who received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) within 3 months prior to screening;
  • Pregnant or lactating women, recent planned pregnancy and unable to ensure effective contraception during the period;
  • Other conditions that the investigator considers the participant is not suitable for the study.

Treatment and study plan

Toludesvenlafaxine hydrochloride sustained-release tablets

Drug

80 mg or 120 mg or 160 mg orally once daily dosing for 8 weeks

Venlafaxine hydrochloride sustained-release tablets

Drug

75 mg or 150 mg or 225 mg orally once daily dosing for 8 weeks

Primary outcomes

  1. Snaith-Hamilton Pleasure Scale (SHAPS) Total Score

    Time frame: 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 outcomes

  1. Snaith-Hamilton Pleasure Scale (SHAPS) Total Score

    Time frame: 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.

  2. Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate

    Time frame: 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.

  3. Dimensional Anhedonia Rating Scale (DARS) Score

    Time frame: 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).

  4. Montgomery-Asberg Depression Rating Scale (MADRS) Score

    Time frame: 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.

  5. 17-item Hamilton Depression Rating Scale (HAM-D17) Score

    Time frame: 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.

  6. Sheehan Disability Scale (SDS) Score

    Time frame: 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.

  7. Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score

    Time frame: 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 outcomes

  1. Treatment Emergent Symptom Scale (TESS) Score

    Time frame: 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.

  2. Arizona Sexual Experience Scale (ASEX) Score

    Time frame: 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.

  3. Count of red blood cell in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether count of red blood cell in blood show any significant trend with time changes.

  4. Count of white blood cell in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether count of white blood cell in blood show any significant trend with time changes.

  5. Count of platelet in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether count of platelet in blood show any significant trend with time changes.

  6. Concentration of hemoglobin in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of hemoglobin in blood show any significant trend with time changes.

  7. Concentration of alanine aminotransferase in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of alanine aminotransferase in blood show any significant trend with time changes.

  8. Concentration of aspartate aminotransferase in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of aspartate aminotransferase in blood show any significant trend with time changes.

  9. Concentration of gamma-glutamyltransferase in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of gamma-glutamyltransferase in blood show any significant trend with time changes.

  10. Concentration of blood glucose in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of blood glucose in blood show any significant trend with time changes.

  11. Concentration of serum creatinine in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of serum creatinine in blood show any significant trend with time changes.

  12. Concentration of urea in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of urea in blood show any significant trend with time changes.

  13. Concentration of total cholesterol in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of total cholesterol in blood show any significant trend with time changes.

  14. Concentration of high density lipoprotein in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of high density lipoprotein in blood show any significant trend with time changes.

  15. Concentration of low density lipoprotein in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of low density lipoprotein in blood show any significant trend with time changes.

  16. Concentration of triglyceride in blood

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of triglyceride in blood show any significant trend with time changes.

  17. Concentration of protein in urine

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of protein in urine show any significant trend with time changes.

  18. Concentration of sugar in urine

    Time frame: Baseline, the end of Week 8

    To analysis whether concentration of sugar in urine show any significant trend with time changes.

  19. Count of white blood cell in urine

    Time frame: Baseline, the end of Week 8

    To analysis whether count of white blood cell in urine show any significant trend with time changes.

  20. Count of red blood cell in urine

    Time frame: Baseline, the end of Week 8

    To analysis whether count of red blood cell in urine show any significant trend with time changes.

  21. ECG QT Interval

    Time frame: Baseline, the end of Week 8

    To analysis whether ECG QT Interval of participants show any significant trend with time changes.

  22. Changes in weight

    Time frame: Baseline, the end of Week 2, 4 and 8

    To analysis whether weight of participants show any significant trend with time changes.

  23. Changes in pulse

    Time frame: Baseline, the end of Week 2, 4 and 8

    To analysis whether pulse of participants show any significant trend with time changes.

  24. Changes in both systolic and diastolic blood pressure

    Time frame: Baseline, the end of Week 2, 4 and 8

    To analysis whether blood pressure including systolic blood pressure and diastolic blood pressure of participants show any significant trend with time changes.

  25. Changes in respiration rate

    Time frame: Baseline, the end of Week 2, 4 and 8

    To analysis whether respiration rate of participants show any significant trend with time changes.

  26. Changes in armpit temperature

    Time frame: Baseline, the end of Week 2, 4 and 8

    To analysis whether armpit temperature of participants show any significant trend with time changes.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder: a Multicentre, Open-label, Parallel-group, Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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