Comparative Efficacy of Escitalopram Monotherapy and Escitalopram-Melatonin Combination Therapy in Treating Major Depressive Disorder-A Randomized Interventional Study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. To compare the efficacy of combination therapy of escitalopram and melatonin versus escitalopram alone in the treatment of MDD using Hamilton Depression Rating Scale (HDRS).
研究概览
简要总结
Currently the efficacy of depression therapy is limited due to the need of long term treatment and variation in symptom presentation. The large treatment refractory patients indicates the need to explore additional anti depressants treatments with fewer side effects. Hence this study aims at studying the antidepressant role of melatonin as add on drug. Till date no study had been conducted comparing the efficacy and safety of escitalopram melatonin combination versus escitalopram monotherapy in major depressive disorder.
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
- •Patients diagnosed with MDD but without history of insomnia according to DSM V criteria.
- •Patients of either sexes above 18 years of age.
排除标准
- •Patients with organic cause of depression such as stroke, Alzheimer’s, Parkinsons, intracranial tumors, epilepsy etc.
- •Patients with severe depressive episodes with psychotic symptoms.
- •Pregnant and lactating females.
- •Patients in which these medications are contraindicated.
结局指标
主要结局
1. To compare the efficacy of combination therapy of escitalopram and melatonin versus escitalopram alone in the treatment of MDD using Hamilton Depression Rating Scale (HDRS).
时间窗: 3 months and 6 months
2. To compare the safety of the combination therapy of escitalopram and melatonin versus escitalopram monotherapy using AE (Adverse Event) and ADR (Adverse Drug Reaction) in adult patients of MDD.
时间窗: 3 months and 6 months
次要结局
- To assess the quality of life of patients of MDD taking escitalopram versus escitalopram and melatonin combination therapy using WHO BREF questionnaire.(3 months and 6 months)
研究者
Dr Sakshi Sharma
Indira Gandhi Medical College, Shimla (H.P.)