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

Inclusion Criteria:

• Subjects meet the diagnostic criteria for major depression disorder in theDiagnostic 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) ≥3points;

• Subjects voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

• Allergic or known to be allergic to toludesvenlafaxine hydrochloridesustained-release tablets and venlafaxine hydrochloride sustained-release tablets;

• Subjects have a severe self-injury/clear suicide attempt or behavior; Scores onHAM-D17 items factor 3 ≥3 points;

• Subjects who meet the diagnostic criteria for any other psychotic disorders inDSM-5;

• Subjects who meet the diagnostic criteria for substance disorders or alcohol abusein DSM-5 (except for nicotine or caffeine) within the past six months;

• Individuals with severe and unstable physical diseases such as cardiovasculardisease, 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 ofscreening and that the investigator considers as inappropriate conditions forinclusion, such as QTc interval >450 ms in men and QTc interval >460 ms in female;

• Subjects who received electroconvulsive therapy (ECT) or transcranial magneticstimulation (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 effectivecontraception during the period;

• Other conditions that the investigator considers the participant is not suitable forthe study.