Comparison Of Efficacy and Safety of Escitalopram Versus Desvenlafaxine In Major Depressive Disorder In a Tertiary Care Hospital: A Prospective Randomised Open Label Study.”
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare and assess the efficacy of escitalopram versus Desvenlafaxine in treating major depressive disorder
研究概览
简要总结
This study compares the efficacy and safety of Escitalopram (an SSRI) and Desvenlafaxine (an SNRI) in treating Major Depressive Disorder (MDD) at a tertiary care hospital. It is a prospective, randomized, open-label study involving 100 newly diagnosed, drug-naive MDD patients aged 18–60 years. Patients are assessed at baseline, 4, 8, and 12 weeks using the Hamilton Depression Rating Scale and laboratory investigations. The primary objective is to compare treatment efficacy; the secondary objective is to evaluate safety using WHO causality and Hartwig and Siegel scores. The study adheres to ethical guidelines and has received Institutional Ethics Committee approval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •· Drug naive patients diagnosed with major depression and started with antidepressants in outpatient of department of psychiatry.
- •· Patients who are willing to give informed consent.
排除标准
- •· Age: LESS THAN 18 AND MORE THAN 60yrs · Patients with Bipolar depression.
- •· Patients who are not willing to give informed consent.
- •· Uncooperative patients.
结局指标
主要结局
To compare and assess the efficacy of escitalopram versus Desvenlafaxine in treating major depressive disorder
时间窗: 0,4,8,12 weeks
次要结局
- To compare and assess the safety of escitalopram versus Desvenlafaxine in treating major depressive disorder(0,4,8,12 weeks)
研究者
Mayank Pande
IGGMC Nagpur