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
Overview
- Phase
- Not Applicable
- Intervention
- Toludesvenlafaxine hydrochloride sustained-release tablets
- Conditions
- Anhedonia
- Sponsor
- Jiangsu Province Nanjing Brain Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Detailed Description
The study included 80 patients with major depression disorder (aged 18 to 65 years) who meet the diagnostic criteria for depression in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Eligible patients were randomly assigned (1:1) to 8-week treatment with toludesvenlafaxine hydrochloride sustained-release tablets (n=40) or desvenlafaxine succinate sustained-release tablets(n=40), followed up at period of enrollment as baseline and at the end of 2th, 4th and 8th weeks. Adverse events were recorded.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Toludesvenlafaxine hydrochloride sustained-release tablets treatment group
Intervention: Toludesvenlafaxine hydrochloride sustained-release tablets
Desvenlafaxine succinate sustained-release tablets treatment group
Intervention: Desvenlafaxine succinate sustained-release tablets
Outcomes
Primary Outcomes
Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
Time Frame: Baseline and the end of week 8
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
Secondary Outcomes
- Montgomery-Asberg Depression Rating Scale (MADRS) Score(Baseline, the end of Week 2, 4 and 8)
- Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score(Baseline, the end of Week 2, 4 and 8)
- Sheehan Disability Scale (SDS) 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)
- 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)