Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 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 alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration, or represent the clinical status of depressed patients.
详细描述
The purpose of this study is to determine whether antidepressants effect on signal transduction in peripheral lymphocyte and to determine whether the signaling differences between drug responders and nonresponders predict the antidepressant response or represent the clinical status of depressed patients.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •met the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) criteria for MDD from the Department of Psychiatry, Sungkyunkwan University, Seoul, South Korea.
- •were 18 years of age or older, the existence of a unipolar major depressive episode as verified by DSM-III/IV criteria, at least 2 years after first episode onset, and agreement to informed consents
排除标准
- •pregnancy
- •significant medical conditions
- •abnormal laboratory baseline values
- •unstable psychiatric features (e.g, suicidal attempt)
- •history of alcohol or drug dependence, seizure, neurological illness, or concomitant Axis I psychiatric disorder
研究组 & 干预措施
antidepressant response
antidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score
干预措施: antidepressant response (Drug)
antidepressant non-response
antidepressant non-response are refered the patients having a 50 > Decrease rate(%) of HAM-D score
干预措施: antidepressant non-response (Drug)
结局指标
主要结局
Antidepressant Response at 6 weeks
时间窗: 6 weeks
Rsponse is defined as decrease rate of HAM-D score for 6week of treament is = 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