Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- all pharmacogenetic and biological marker variables cause drug response
研究概览
简要总结
The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.
详细描述
The difficulties to treat depressed patients are 1)the patients don't respond to antidepressant is about 40% of which, and 2) The time lag is existed until the patients respond to antidepressant and show the treatment effects.
If it is predicted the response of antidepressant in advance, it would be overcome such problems. Drug response generally is known to be related to the individual genetic information and the environmental factors. We are going to investigation about antidepressant response using these approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25 < age <85
- •major depressed patients satisfied with the diagnosis criteria depression of DSM-IV
- •interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians
排除标准
- •received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
- •potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.
研究组 & 干预措施
SSRI treated group
SSRI treated group are depressive patients treated with fluoxetine, paroxetine, citalopram or sertraline
干预措施: SSRI treated group (Drug)
non-SSRI treated group
non-SSRI treated group are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine
干预措施: non-SSRI treated group (Drug)
结局指标
主要结局
all pharmacogenetic and biological marker variables cause drug response
时间窗: 24weeks
次要结局
- all clinical cause drug response(24weeks)
研究者
Doh Kwan Kim
M.D., Ph.D
Samsung Medical Center