Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder

Inclusion Criteria:

• Subjects meet the diagnostic criteria for major depression disorder in the Diagnosticand Statistical Manual of Manual Disorders, fifth Edition (DSM-5);
• Male or female aged ≥18 and ≤65 years;
• Subjects who have a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥24points;
• 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-releasetablets and desvenlafaxine succinate sustained-release tablets;
• Subjects have a severe self-injury/clear suicide attempt or behavior; Scores on MADRSitems factor 10 ≥4 points;
• Subjects who meet the diagnostic criteria for any other psychotic disorders (exceptfor major depression disorder) in DSM-5, or those who have substance disorders or drugabuse 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);
• Total bilirubin (TBIL) values 1.5 times / alanine aminotransferase (ALT) or aspartateaminotransferase (AST) 2 times / creatinine (Cr) 1.2 times higher than the upper limitof normal, or Thyroid-stimulating hormone (TSH) outside the normal range 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;
• 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.