A Comparative Study of Efficacy and Safety of Vortioxetine with Escitalopram in Patients of Major Depressive Disorder at Tertiary Care Hospital
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- The Proportion of Participants achieving HAM D score of 7 at 12 weeks with vortioxetine vs escitalopram
研究概览
简要总结
Objective: To compare efficacy and safety of Vortioxetine with Escitalopram in treatment of major depressive disorder (MDD).
Methods: A prospective, randomized, active-controlled, and parallel–group comparative open label study will be conducted among 88 patients of MDD attending psychiatry OPD of a tertiary care center. They were divided into control and experimental groups receiving Escitalopram and Vortioxetine respectively. Hamilton depression rating scale (HAM-D), Hamilton anxiety rating scale (HAM-A), Montgomery-Asberg depression rating scale (MADRS), clinical global impression improvement (CGI-I), and CGI-severity (CGI-S) scores were assessed at the end of 1st, 2nd, 4th, and 12th weeks in both the groups.
This comparative study examines the efficacy and safety of two commonly prescribed antidepressants, Vortioxetine and Escitalopram, in treating Major Depressive Disorder (MDD). Conducted at a Tertiary Care Hospital, the research aims to provide insights into the relative effectiveness and tolerability of these medications. Through a rigorous analysis of patient outcomes, including symptom reduction, side effects, and overall treatment adherence, the study seeks to offer valuable guidance to clinicians in selecting the most appropriate pharmacological intervention for individuals with MDD. By comparing the benefits and risks of Vortioxetine and Escitalopram, this research contributes to optimizing therapeutic approaches for managing depression in clinical practice.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult Patients (18-65 years old) diagnosed with MDD based on DSM-5 criteria.
- •Patients Presenting to the tertiary Care Hospital outpatient Department with moderate to severe symptoms.
排除标准
- •â€¢Patients with a history of bipolar disorder, psychotic disorder, or substance abuse within the past six months.
- •â€¢Concurrent use of other antidepressants or psychotropic medications.
- •â€¢Patients with previous depression resistant to antidepressants and those who had taken treatment with ECT in previous 3 months or formal psychotherapy within 1 month.
- •â€¢Pregnancy or lactation.
- •â€¢Patients with drug intake for psychosis or anxiety.
- •â€¢Any history of allergy to the drugs.
结局指标
主要结局
The Proportion of Participants achieving HAM D score of 7 at 12 weeks with vortioxetine vs escitalopram
时间窗: Till 12 weeks
次要结局
- 1 To assess the safety & tolerability profiles of vortioxetine & escitalopram.(2 To explore any demographic or clinical factors that may influence treatment response.)
研究者
Dr ARAVIND MANOJ KUMAR R
Vilasrao Deshmukh Government Medical College