Clinical trial NCT06278038: Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression Disorder
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
timeFrame: Baseline and the end of week 8
Secondary outcomes:
measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
timeFrame: Baseline, the end of Week 2 and 4
measure: Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate
timeFrame: The end of Week 2, 4 and 8
measure: Dimensional Anhedonia Rating Scale (DARS) Score
timeFrame: Baseline, the end of Week 2, 4 and 8
measure: Montgomery-Asberg Depression Rating Scale (MADRS) Score
timeFrame: Baseline, the end of Week 2, 4 and 8
measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score
timeFrame: Baseline, the end of Week 2, 4 and 8
measure: Sheehan Disability Scale (SDS) Score
timeFrame: Baseline, the end of Week 2, 4 and 8
measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score
timeFrame: Baseline, the end of Week 2, 4 and 8
Other outcomes:
measure: Treatment Emergent Symptom Scale (TESS) Score
timeFrame: The end of Week 2, 4 and 8
measure: Arizona Sexual Experience Scale (ASEX) Score
timeFrame: Baseline, the end of Week 2, 4 and 8
measure: Count of red blood cell in blood
timeFrame: Baseline, the end of Week 8
measure: Count of white blood cell in blood
timeFrame: Baseline, the end of Week 8
measure: Count of platelet in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of hemoglobin in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of alanine aminotransferase in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of aspartate aminotransferase in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of gamma-glutamyltransferase in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of blood glucose in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of serum creatinine in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of urea in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of total cholesterol in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of high density lipoprotein in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of low density lipoprotein in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of triglyceride in blood
timeFrame: Baseline, the end of Week 8
measure: Concentration of protein in urine
timeFrame: Baseline, the end of Week 8
measure: Concentration of sugar in urine
timeFrame: Baseline, the end of Week 8
measure: Count of white blood cell in urine
timeFrame: Baseline, the end of Week 8
measure: Count of red blood cell in urine
timeFrame: Baseline, the end of Week 8
measure: ECG QT Interval
timeFrame: Baseline, the end of Week 8
measure: Changes in weight
timeFrame: Baseline, the end of Week 2, 4 and 8
measure: Changes in pulse
timeFrame: Baseline, the end of Week 2, 4 and 8
measure: Changes in both systolic and diastolic blood pressure
timeFrame: Baseline, the end of Week 2, 4 and 8
measure: Changes in respiration rate
timeFrame: Baseline, the end of Week 2, 4 and 8
measure: Changes in armpit temperature
timeFrame: Baseline, the end of Week 2, 4 and 8
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: