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

NCT06278038 | Completed

• 1 other identifier: RXL-RCT-02
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Snaith-Hamilton Pleasure Scale (SHAPS) Total Score

  Baseline, the end of Week 2 and 4

• Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate

  The end of Week 2, 4 and 8

• Dimensional Anhedonia Rating Scale (DARS) Score

  Baseline, the end of Week 2, 4 and 8

• Montgomery-Asberg Depression Rating Scale (MADRS) Score

  Baseline, the end of Week 2, 4 and 8

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

  Baseline, the end of Week 2, 4 and 8

Other Outcomes (26)

• Treatment Emergent Symptom Scale (TESS) Score

  The end of Week 2, 4 and 8

• Arizona Sexual Experience Scale (ASEX) Score

  Baseline, the end of Week 2, 4 and 8

• Count of red blood cell in blood

  Baseline, the end of Week 8

Study Arms (2)

Toludesvenlafaxine hydrochloride sustained-release tablets treatment group

EXPERIMENTAL

Drug: Toludesvenlafaxine hydrochloride sustained-release tablets

Venlafaxine hydrochloride sustained-release tablets treatment group

ACTIVE COMPARATOR

Drug: Venlafaxine hydrochloride sustained-release tablets

Interventions

Toludesvenlafaxine hydrochloride sustained-release tablets DRUG

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

Toludesvenlafaxine hydrochloride sustained-release tablets treatment group

Venlafaxine hydrochloride sustained-release tablets DRUG

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

Venlafaxine hydrochloride sustained-release tablets treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 26, 2024
• Study Start: February 22, 2024
• Primary Completion: November 10, 2024
• Study Completion: November 19, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

CN (1)