RecruitingNot ApplicableNCT06270433

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

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder: a Multicentre, Open-label, Parallel-group, Randomised Controlled Trial

Sponsor

Jiangsu Province Nanjing Brain Hospital

Enrollment

80 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Anhedonia

Summary

The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of anhedonia in patients with major depression disorder compared to desvenlafaxine succinate sustained-release tablets, to provide evidence-based basis for clinical rational drug use.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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 Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥24 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 Criteria9

Allergic or known to be allergic to toludesvenlafaxine hydrochloride sustained-release tablets and desvenlafaxine succinate sustained-release tablets;
Subjects have a severe self-injury/clear suicide attempt or behavior; Scores on MADRS items factor 10 ≥4 points;
Subjects who meet the diagnostic criteria for any other psychotic disorders (except for major depression disorder) in DSM-5, or those who have substance disorders or drug abuse 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 aspartate aminotransferase (AST) 2 times / creatinine (Cr) 1.2 times higher than the upper limit of normal, or Thyroid-stimulating hormone (TSH) outside the normal range 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;
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.