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RECRUITING

NCT06270433

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

Sponsor: Jiangsu Province Nanjing Brain Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-02-19

Completion Date

2024-12-31

Last Updated

2024-04-29

Healthy Volunteers

Conditions

Anhedonia

Interventions

DRUG

Toludesvenlafaxine hydrochloride sustained-release tablets

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

DRUG

Desvenlafaxine succinate sustained-release tablets

50 mg orally once daily dosing for 8 weeks

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 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 Criteria: * 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.

Locations (1)

Nanjing Brian Hospital

Nanjing, Jiangsu, China