NCT01039740Unknown不适用
Pharmacogenetic Study of Mirtazapine Response in Depressed Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mirtazapine response at 2,4,6 weeks and adverse events (A/E) monitoring at 1,2,4,6 weeks
研究概览
简要总结
The purpose of this study is to determine whether pharmacogenetic study predict Mirtazapine responsiveness in advance before the appearance of the drug effect until 4-6 weeks after administration of Mirtazapine.
详细描述
The purpose of this study is
- to determine whether genomic differences between drug responders and nonresponders predict the response of Mirtazapine and
- to construct the prediction model for Mirtazapine treatment in depressed patients in order to aid to select the genetically matching drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (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
- 否
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
Experimental
Reponders is a patients group who showed 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine
干预措施: Mirtazapine (Drug)
Non-responders
Experimental
Non-responders is a patients group who did not show 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine
干预措施: Mirtazapine (Drug)
结局指标
主要结局
Mirtazapine response at 2,4,6 weeks and adverse events (A/E) monitoring at 1,2,4,6 weeks
时间窗: 6 weeks
次要结局
- Biological value at 0 and 6 weeks(6 weeks)
研究者
Doh Kwan Kim
M.D., Ph.D.
Samsung Medical Center
研究点 (1)
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