Randomized Clinical Trial Comparing Efficacy of Optimal Treatment and Conventional Treatment for Major Depressive Disorder in Viet Nam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Comparison of rate of respond patient between optimization and routine treatment group
研究概览
简要总结
Comparison of efficacy treatment (respond, remission) between the optimized treatment group (dose adjustment or early change other drug based on the change of total score HAM-D 17) and the routine treatment group (start with the lowest effective dose and adjust dose slowly) for depressed patients in Viet Nam
详细描述
Major depressive disorder (MDD) is a common with a lifetime prevalence about 16 %. MDD is able to be a recurrent and chronic condition. MDD is the second leading cause of disability worldwide. This disorder can reduce an individual's ability to perform at work or school to fulfill family responsibilities and to enjoy almost daily activities. Some evidences suggest that delay in treatment of MDD result in poorer outcome; longer time to remission is associated with residual symptoms, chronic condition, relapse and poorer recovery.
OBJECTIVE:
This study will compare effectiveness of the treatment by using measurement base care, accessing early improvement or lack of improvement to make decisions about regard to dose alteration, switching another antidepressant with standard treatment.
METHOD:
This study is the 8 week randomized controlled trial. Raters blind to protocol and 2 treatment group. This study conduct from March 2021 to March 2022 in UMC hospital, Ho Chi Minh city, Vietnam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •New or first recurrent diagnosed as major depression disorder.
- •Having total score HAM-D 17 ≥ 17 point
排除标准
- •Can not answer the question in HAM-D 17
- •Having psychosis, anxiety disorder, obsessive-compulsive disorder
- •Having risk of suicide now or 3 months past
- •having medical history: diabetes mellitus, hypothyroidism, hypopituitarism, epilepsy, renal failure, heart failure, stroke, myocardial infarction, liver failure, cirrhosis.
- •Pregnancy
结局指标
主要结局
Comparison of rate of respond patient between optimization and routine treatment group
时间窗: 8 weeks
Rate of responsers has HAMD-17 score decreases over 50 percent in each treatmennt group at each visit
次要结局
未报告次要终点
研究者
Le Nguyen Thuy Phuong
Medical doctor
University of Medicine and Pharmacy at Ho Chi Minh City