Predict Antidepressant Responsiveness Using Pharmacogenomics
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Presences of each individual symptom of depression at 1,2,4,6,12 weeks
研究概览
简要总结
The purpose of this study is to determine whether genetic information associated with individual depressive symptoms.
详细描述
The primary hypothesis is that the variations of the candidate genes are associated with individual symptoms in patients with depression.
The Second hypothesis is that patients with the associated genetic variation suffer longer from the associated symptom than the patients without the associated genetic variation.
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
- 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
SSRI treated group
SSRI treated group is patients treated with fluoxetine, paroxetine, or sertraline
干预措施: SSRI treated group (Drug)
non-SSRI treated group
non-SSRI treated group is patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine
干预措施: non-SSRI treated group (Drug)
结局指标
主要结局
Presences of each individual symptom of depression at 1,2,4,6,12 weeks
时间窗: 12 weeks
17-items HAM-D scale was employed to measure depressive symptoms
次要结局
未报告次要终点
研究者
Doh Kwan Kim
M.D., Ph.D.
Samsung Medical Center