Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder: a Multicentre, Open-label, Parallel-group, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of major depression disorder compared to venlafaxine hydrochloride sustained-release tablets, to provide evidence-based basis for clinical rational drug use.
详细描述
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 venlafaxine hydrochloride 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥18 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.
排除标准
- •Allergic or known to be allergic to toludesvenlafaxine hydrochloride sustained-release tablets and venlafaxine hydrochloride sustained-release tablets;
- •Subjects have a severe self-injury/clear suicide attempt or behavior; Scores on HAM-D17 items factor 3 ≥3 points;
- •Subjects who meet the diagnostic criteria for any other psychotic disorders in DSM-5;
- •Subjects who meet the diagnostic criteria for substance disorders or alcohol abuse in DSM-5 (except for nicotine or caffeine) 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);
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 times / creatinine (Cr) 1.2 times higher than the upper limit of normal 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;
- •Subjects who received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within 3 months prior to screening;
- •Subjects who received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) within 3 months prior to 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.
研究组 & 干预措施
Toludesvenlafaxine hydrochloride sustained-release tablets treatment group
干预措施: Toludesvenlafaxine hydrochloride sustained-release tablets (Drug)
Venlafaxine hydrochloride sustained-release tablets treatment group
干预措施: Venlafaxine hydrochloride sustained-release tablets (Drug)
结局指标
主要结局
Snaith-Hamilton Pleasure Scale (SHAPS) Total Score
时间窗: 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, with higher scores corresponding to higher levels of anhedonia.
次要结局
- Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) 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)
- Sheehan Disability Scale (SDS) Score(Baseline, the end of Week 2, 4 and 8)
- Dimensional Anhedonia Rating Scale (DARS) 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)