CTRI/2025/09/094893尚未招募Unknown
Effectiveness and safety of Dextromethorphan-bupropion versus Escitalopram in treatment of major depressive disorder
TEJASWI P1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年9月30日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The primary efficacy variable will be the change in MADRS total score
研究概览
简要总结
This a prospective interventional RCT to be conducted at ESICMC and PGIMSR to know the effectiveness and safety of dextromethorphan bupropion combination versus escitalopram in treatment of major depressive disorder
Dextromethorphan bupropion combination treatment has an additional advantage of less side effects and faster symptomatic relief in depression patients when compared to escitalopram
so i would like to do study on this drug to know its effectiveness and safety profile for better treatment and benefit of patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •1 Patients willing to give written informed consent 2 Newly diagnosed patients with major depressive disorder of either sex aged between 18 and 65 years and a current episode of major depressive disorder 3 Diagnosis will be made based on DSM 5 criteria 4 A minimum score of more than or equal to 25 on Montgomery-Asberg depression rating scale MADRS 5 Minimum score of more than or equal to 4 on clinical global impression severity scale CGI S.
排除标准
- •1 Pregnant or lactating females 2 Patients with medical conditions like hepatic or renal failure 3 Past history of any cardiac disease 4 History of bipolar disorder 5 History of panic disorder 6 History of obsessive compulsive disorder 7 History of treatment resistance depression defined as having at least two failed adequate antidepressants treatments in current major depressive episode 8 History of psychotic disorder 9 Clinically risk of suicide assessed by C SSRS 10 History of seizures 11 Patients on treatment with any other drugs which are CYP2D6 inducers or inhibitors.
结局指标
主要结局
The primary efficacy variable will be the change in MADRS total score
时间窗: 6 WEEKS
from baseline to week 6
时间窗: 6 WEEKS
次要结局
- 1 Reduction more than or equal to 50% from baseline in MADRAS total score known as clinical(response)
研究者
TEJASWI P
ESIC MEDICAL COLLEGE AND PGIMSR
研究点 (1)
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