CTRI/2022/07/043662尚未招募不适用
A 12-week Randomized Controlled Study to compare the antidepressant efficacy of Vortioxetine and Escitalopram in patients with depressive episode
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 17-item Hamilton Depression Scale (HAM-D17) done at baseline, 2nd week, 4th week and 12th weeks
研究概览
简要总结
Vortioxetine is a novel antidepressant, promoted for its multi-modal actions and comparatively lesser side effects. Not many studies have compared the clinical efficacy of vortioxetine to commonly prescribed oral antidepressants. Hence in our study we intend to compare the efficacy of vortioxetine to escitalopram for a period of 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who are meeting International Classification of Diseases 10 criteria for major depressive disorder Patients who gave informed written consent.
排除标准
- •Patients with other comorbid psychiatric disorder (except major depressive disorder) Patients who were having comorbid substance dependence Patients with any other medical disorder which is confounding our inclusion diagnosis.
结局指标
主要结局
17-item Hamilton Depression Scale (HAM-D17) done at baseline, 2nd week, 4th week and 12th weeks
时间窗: 17-item Hamilton Depression Scale (HAM-D17) done at baseline, 2nd week, 4th week and 12th weeks
次要结局
- CGI- severity of illness (CGI-S) and improvement scale (CGI-I) done at baseline, 2nd week, 4th week and 12th week(CGI- severity of illness (CGI-S) and improvement scale (CGI-I) done at baseline, 2nd week, 4th week and 12th week)
研究者
研究点 (1)
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