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

Major Depression Disorder Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278038
• Other study ID #: NO.0057 in 2024 Ethical Review
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression Disorder

Intervention

Drug:
• Toludesvenlafaxine hydrochloride sustained-release tablets
80 mg or 120 mg or 160 mg orally once daily dosing for 8 weeks
• Venlafaxine hydrochloride sustained-release tablets
75 mg or 150 mg or 225 mg orally once daily dosing for 8 weeks

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	The end of Week 2, 4 and 8
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	ECG QT Interval	To analysis whether ECG QT Interval of participants show any significant trend with time changes.	Baseline, the end of Week 8
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	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, the end of Week 2 and 4
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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