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临床试验/NCT04208932
NCT04208932Unknown不适用

A Kynurenine Pathway-based Molecular Imaging Study of Individualized Diagnosis and Treatment for Major Depressive Disorder

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2019年8月12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
入组人数
440
试验地点
1
主要终点
remission of acute phase

研究概览

简要总结

Major depressive disorder (MDD) is a chronic disease with high incidence rate, high recurrent rate and need whole course medical management. Varied clinical symptoms and unclear pathogenesis cause a series of clinical problem, such as low diagnostic rate and low effective treatment rate. Based on neuroimmune mechanisms of MDD, our previous study indicates that kynurenine pathway (KP) in serum may be the connections between central immune and peripheral immune, that key factors of KP may change the brain structure and function through affecting the central immune. The core research issue of this project are the inherent associations between metabonomics of inflammatory factors in KP, clinical phenotypes of MDD, and neuroimaging features. This project will focus on first-episode MDD, mass spectrometry analysis of KP factors will be conducted first, also multi-modal neuroimaging techniques will be applied to detect topological characteristics of brain structure and function in MDD and extract standard models, then correlation analyses will be performed between these molecular biological features and multi-dimensional clinical data in order to integrate KP metabonomics, core clinical characteristics (depressed mood, energy loss, interest loss and so on), neuroimaging biomarkers, and finally construct the deep learning based standard diagnostic technique of MDD. Additionally, this project will follow up MDD patients with different core clinical characteristics to certificate the aforementioned diagnostic technique as well as explore optimized treatment for different clinical subtypes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-60 years old;
  • Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
  • Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
  • With enough audio-visual ability and comprehensive ability to accomplish the visits;
  • Be necessary and suitable to accept the treatment of antidepressants;
  • Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
  • With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment.

排除标准

  • Severe medical or neurological problems;
  • Previous mania or hypomania episodes;
  • Female patients who are pregnant, planning to be pregnant or breastfeeding;
  • Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);
  • Had electroconvulsive therapy, modified electroconvulsive therapy or repetitive transcranial magnetic stimulation in the past 6 months;
  • Experienced severe personality disorder, mental retardation, anorexia/bulimia nervosa.

研究组 & 干预措施

MDD

major depressive disorder

干预措施: SSRIs (Drug)

结局指标

主要结局

remission of acute phase

时间窗: 12th week

scored 7 or lower on the Hamilton's Depression Scale with 24 items

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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