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

NCT ID: NCT06278038

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-22
• Study Completion Date: 2024-11-19

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.

Conditions

Major Depression Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Toludesvenlafaxine hydrochloride sustained-release tablets treatment group

Group Type: EXPERIMENTAL

Toludesvenlafaxine hydrochloride sustained-release tablets

Intervention Type: DRUG

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

Venlafaxine hydrochloride sustained-release tablets treatment group

Group Type: ACTIVE_COMPARATOR

Venlafaxine hydrochloride sustained-release tablets

Intervention Type: DRUG

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

Interventions

Toludesvenlafaxine hydrochloride sustained-release tablets

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

Intervention Type: DRUG

Venlafaxine hydrochloride sustained-release tablets

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

RXL-RCT-02

Identifier Type: -

Identifier Source: org_study_id