Vortioxetine versus Escitalopram in Major Depressive Disorder A Comparative Study of Efficacy, Safety, Functional Improvement and Quality of Life
试验速览
- 阶段
- 不适用
- 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 the efficacy of vortioxetine and escitalopram in improving depressive symptoms in patients with moderate to major depressive disorder, using standardized rating scales over a 24-week treatment period.
研究概览
简要总结
The study " Vortioxetine versus Escitalopram in Major Depressive Disorder: A Comparative Study of Efficacy, Safety, Functional Improvement and Quality of Life" will be conducted at the Department of Pharmacology in association with the Department of Psychiatry, Santosh Medical College and Hospital, Ghaziabad, Uttar Pradesh, 201009.
The subjects of the study will be the patients of Major Depressive Disorder attending the Psychiatry Outpatient Department, Santosh hospital, Ghaziabad, Uttar Pradesh based on the inclusion and exclusion criteria.
All patients selected for the study will be well informed about the study and a written informed consent will be taken. After recruitments patients will be allocated into two groups by randomization technique.
Group A will be treated with Vortioxetine 20mg/day for 24 weeks.
Group B will be treated with Escitalopram 20mg/day for 24 weeks.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18-55 years diagnosed with moderate major depressive disorder based on DSM-5 criteria.
- •Patients with a Hamilton Depression Rating Scale score between 14-22 indicating moderate depression.
- •Those who have not used antidepressants in the past three months.
- •Those patients or caregivers who are willing to give written infomred consent form.
排除标准
- •Who have not previously experienced hypersensitivity or contraindication to vortioxetine or escitalopram 2)Clinical situation requiring alternative drugs or intervention.
- •Drugs which are CYP3A4/2D6 and CYP2C19 inhibitors and inducers ( Concomitant medication) 4)Any co-morbid neurological or mental disorder.
- •Any serious medical/surgical illness.
- •Established treatment resistance to antidepressants 7)History of drug or alcohol abuse in the last six months.
结局指标
主要结局
To compare the efficacy of vortioxetine and escitalopram in improving depressive symptoms in patients with moderate to major depressive disorder, using standardized rating scales over a 24-week treatment period.
时间窗: baseline, 8, 16 and 24 weeks
次要结局
- To evaluate the safety & tolerability of vortioxetine & escitalopram by assessing adverse events & dropout rates during the treatment course.(To assess functional improvement in patients receiving either vortioxetine or escitalopram using tools like the Sheehan Disability Scale (SDS).)
研究者
DR GARIMA GUPTA
SANTOSH MEDICAL COLLEGE, SDTU