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临床试验/NCT02023567
NCT02023567Unknown不适用

The Establishment of the Objective Diagnostic Markers and Personalized Medical Intervention in Patients With Major Depressive Disorders (MDD)

Peking University9 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
2,400
试验地点
9
主要终点
The changes of HAMD total score at 8 weeks from baseline

研究概览

简要总结

Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high recurrence rate, suicide rate and disability rate. It's reported that the global burden caused by MDD will be up to the second rank among all the disease burdens by 2020. China is also confronted with the daunting challenges against MDD. It's assessed that the monthly incidence of MDD is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment rate is approximate 95%. However, to date, the pathogenesis of MDD is obscure and the current therapies don't work well. Therefore, it's urgent and critical to elucidate the pathogenesis of MDD, to develop early diagnostic criteria and effective intervention in MDD. Considering the diversity of weights on genetic factor and environmental factor in MDD, in this project, the investigators aim firstly to explore the effect of "genetic-environmental interaction"on the pathogeny of MDD for classifying MDD into "genetic type", "environmental type" and "others" based on a case-control study. We next conduct the neurobiological, neurocognitive and psycho-behavioral assessments among MDD, schizophrenia and healthy groups to screen the salient endophenotypes for establishing the diagnostic models of MDD . The investigators further analyse the changes of these indicators after 8 weeks'medication to select the potential predictors for therapeutic evaluations and interventional options in MDD patients. Finally, the investigators continue a 2-year follow-up study to test and verify the predictors of prognosis in MDD 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
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

MDD group

Experimental

Drugs: SSRIs fluoxertine hydrochloride (20- 60m/day),paroxetine hydrochloride (20- 60m/day),sertraline hydrochloride (50- 200m/day),citalopram (20-60m/day), escitalopram (10-20mg/day),fluvoxamine (50-300mg/day)

干预措施: SSRIs (Drug)

结局指标

主要结局

The changes of HAMD total score at 8 weeks from baseline

时间窗: week 0,2,4,8

The scores are assessed at 0,2,4,8 weeks since the medication begins for MDD group

次要结局

  • The change of CGI score at 8 weeks from baseline(week 0,2,4,8)
  • The prognosis after the intervention(Up to 2 years)
  • Number of participants with serious and non-serious adverse events(Up to two years)
  • The changes of HAMA total score at 8 weeks from baseline(week 0,2,4,8)

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xin Yu

Professor

Peking University

研究点 (9)

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