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

NCT06270433 | Recruiting

• 1 other identifier: 2023-KY142-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anhedonia

Outcome Measures

Primary Outcomes (1)

• Snaith-Hamilton Pleasure Scale (SHAPS) Total Score

  The SHAPS is a well-validated 14-item self-report questionnaire commonly used to assess anhedonia. Each item on the SHAPS is worded so that higher scores indicate greater pleasure capacity. A total score can be derived by summing the responses to each item. Each item is rated as either 0 or 1, for a total score between 0 and 14

  Baseline and the end of week 8

Secondary Outcomes (7)

• Snaith-Hamilton Pleasure Scale (SHAPS) Total Score

  Baseline, the end of Week 2 and 4

• Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate

  The end of Week 2, 4 and 8

• Dimensional Anhedonia Rating Scale (DARS) Score

  Baseline, the end of Week 2, 4 and 8

• Montgomery-Asberg Depression Rating Scale (MADRS) Score

  Baseline, the end of Week 2, 4 and 8

• 17-item Hamilton Depression Rating Scale (HAM-D17) Score

  Baseline, the end of Week 2, 4 and 8

Other Outcomes (27)

• Rating Scale for Side Effects (SERS) Score

  The end of Week 2, 4 and 8

• Arizona Sexual Experience Scale (ASEX) Score

  Baseline, the end of Week 2, 4 and 8

• Count of red blood cell in blood

  Baseline, the end of Week 8

Study Arms (2)

Toludesvenlafaxine hydrochloride sustained-release tablets treatment group

EXPERIMENTAL

Drug: Toludesvenlafaxine hydrochloride sustained-release tablets

Desvenlafaxine succinate sustained-release tablets treatment group

ACTIVE COMPARATOR

Drug: Desvenlafaxine succinate sustained-release tablets

Interventions

Toludesvenlafaxine hydrochloride sustained-release tablets DRUG

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

Toludesvenlafaxine hydrochloride sustained-release tablets treatment group

Desvenlafaxine succinate sustained-release tablets DRUG

50 mg orally once daily dosing for 8 weeks

Desvenlafaxine succinate sustained-release tablets treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

Nanjing Brian Hospital

Nanjing, Jiangsu, 210024, China

RECRUITING

MeSH Terms

Conditions

Anhedonia

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 21, 2024
• Study Start: February 19, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

CN (1)