Prediction of Antidepressant Response Using Pharmacogenetics of Bioamine Transporter and Peripheral Lymphocytic Phenotype
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Antidepressant Response at 6 weeks
研究概览
简要总结
The purpose of this study is to determine whether pharmacogenomic study of bioamine transporters and peripheral lymphatic biomarkers(phenotype) predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.
详细描述
The purpose of this study is to determine whether genomic effects or peripheral lymphatic biomarkers on antidepressant response differed by class of drug, whether genomic and biomarker differences between drug responders and nonresponders predict the response of antidepressant and to construct the prediction model for antidepressant treatment in order to aid to select the their genetically or endophenotypic matching drugs.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
- •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
responders
50 ≤ Decrease rate(%) of HAM-D score
干预措施: responders (Drug)
non-responders
nonresponders is a patients having 50 > Decrease rate(%) of HAM-D score
干预措施: non-responders (Drug)
结局指标
主要结局
Antidepressant Response at 6 weeks
时间窗: 6 weeks
antidepressant response is defined as the decrease rate of HAM-D score for 6week was = or \> 50% Measurement Unit = responders, nonresponders
次要结局
- Biological value at 0 and 6 weeks(6 weeks)
研究者
Doh Kwan Kim
M.D., pHD
Samsung Medical Center