A comparative study of vortioxetine and escitalopram on efficacy, tolerability and effects on metabolic parameters in the management of major depressive disorder in a tertiary care hospital.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- To assess the efficacy, tolerability and metabolic parameters on subjects treated with vortioxetine versus escitalopram in the management of major depressive disorder.
研究概览
简要总结
Vortioxetine demonstrates similar efficacy to that observed for duloxetine, escitalopram, levomilnacipran, sertraline, venlafaxine, and vilazodone, however overall tolerability as measured by discontinuation because of an adverse event differs. Vortioxetine is 5.1 times more likely to be associated with response than discontinuation because of an adverse event when compared to placebo. vortioxetine has proven to be efficacious in the treatment of MDD in the majority of trials, whilst also showing good tolerability 2 Besides effective management of depressive symptoms, vortioxetine has properties that may be beneficial as it enhances cognitive functions. The various aspects of vortioxetine and escitalopram on metabolic parameters and tolerability profile in the management of major depressive disorder is relatively under researched entity in developing countries. 5
Hence the metabolic parameters and tolerability profile of vortioxetine and escitalopram in Indian patients could be delineated by results of present study, which may add to existing evidences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •18-45 years of male and female, diagnosed as case of major depressive disorder, not been treated for the index episode.
排除标准
- •Subjects with comorbid psychiatric disorder except for the comorbid anxiety symptoms and tobacco use, known case of diabetes or hypertension or dyslipidemia or hyperthyroidism, hypothyroidism, with medical or surgical condition that affect his or her locomotor capabilities, pregnancy and lactating female.
结局指标
主要结局
To assess the efficacy, tolerability and metabolic parameters on subjects treated with vortioxetine versus escitalopram in the management of major depressive disorder.
时间窗: At baseline, week 4th and week 12th
次要结局
- To assess the treatment adverse effects responsible for intolerance of vortioxetine and escitalopram by using the anti depressant side effect checklist.(Baseline, week 4, week 12.)
- To study the association of efficacy and tolerability of vortioxetine and escitalopram in the management of major depressive disorder.(Baseline, week 4, week 12.)
研究者
Suravi Das
Eras lucknow medical college and hospital