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临床试验/NCT03148522
NCT03148522Unknown不适用

Clinical Psychopharmacology Division,Institute of Mental Health,Peking University

Peking University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年6月1日最近更新:
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
120
试验地点
1
主要终点
Hamilton Rating Scale for Depression

研究概览

简要总结

Major depressive disorder (MDD) is a high-disabling disease. But its etiology and pathogenesis is not clear, and early recognition, diagnosis and treatment still has many challenges. Among numerous clinical manifestations of MDD, anhedonia is an important core symptom of MDD, especially in patients with melancholic features. Our previous studies and studies abroad have shown that MDD patients had functional abnormality in reward circuit. The abnormalities of reward-related core areas, such as the prefrontal cortex - nucleus accumbens - ventral tegmental area were closely associated with the development of MDD, and is an important neural basis of anhedonia. This study would take the reward circuit as mainline to carry out the etiology, diagnosis and therapeutic intervention studies of MDD. We would collect MDD patients with melancholic features and other populations with reward dysfunction. The neuroimaging techniques, stress assessment, genetic testing and drug intervention methods would be mainly used in this study. The functional connectivity of reward regions, such as the ventral striatum, nucleus accumben, and ventral medial prefrontal cortex, would be analyzed to identify the dysfunction of reward circuit of MDD, and its implication for early recognition, diagnosis and prediction of treatment efficacy of antidepressants. We would also investigate the effect of genetic and environmental factors on reward function of MDD and its biological basis. Finally, through modulating the reward circuit activity using animal experiments, we would verify and investigate reward dysfunction of MDD and its biological mechanisms. The project is expected to provide for new evidence for the establishment of reward mechanism - based objective diagnosis and treatment optimization strategy of MDD.

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
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

  • first-episode, drug naive melancholic depression; remitted depression; schizophrenia patients; first-degree relatives of depressed patients.

排除标准

  • major somatic diseases; DSM-IV axis I other mental illness; personality disorder, mental retardation; drug and / or alcohol dependence; serious suicidal tendencies or suicidal behavior; pregnant or lactating women; MRI contraindications.

研究组 & 干预措施

escitalopram

Experimental

Eligible patients were assigned to escitalopram treatment based on investigators' clinical practice.

干预措施: Escitalopram (Drug)

duloxetine

Experimental

Eligible patients were assigned to duloxetine treatment based on investigators' clinical practice.

干预措施: Duloxetine (Drug)

mirtazapine

Experimental

Eligible patients were assigned to mirtazapine treatment based on investigators' clinical practice.

干预措施: Mirtazapine (Drug)

结局指标

主要结局

Hamilton Rating Scale for Depression

时间窗: 8 weeks

remission defined by Hamilton Rating Scale for Depression \< 7

次要结局

未报告次要终点

研究者

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

Si Tianmei

Director of Clinical Psychopharmacology Division Institute of Mental Health, Peking University

Peking University

研究点 (1)

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