跳至主要内容
临床试验/NCT01062880
NCT01062880Unknown不适用

Neuropattern - Clinical Trial of a Psychobiological Stress Diagnostic Tool (Neuropattern - Erprobung Einer Psychobiologischen Stressdiagnostik)

University of Trier2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2010年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
2
主要终点
Documentation and distribution of different endophenotypes (Neuropattern) in patients of family doctors suffering from depressive episodes, major depression, somatoform disorders, and adjustment disorders

研究概览

简要总结

Neuropattern is a first translational tool in stress medicine. Neuropattern is a diagnostic tool, which can be applied by in- and outpatients and physicians to detect dysregulation in the stress response network. The physician provides anamnestic and anthropometric data, while the patient takes other measures at home, e.g. psychological, symptomatic, and biological data. Among the biological data are ECG measures for analyses of heart rate variability, and salivary cortisol measures before and after a dexamethasone challenge test. All data are analyzed in a central laboratory, which generates a written report for the physician, including a disease model, from which personalized recommendations for pharmacological and psychological treatments are derived. Neuropattern additionally offers individualized internet modules to inform the patient about the disease model and to teach him/her what he/she can do to improve his/her medical conditions. The current study applies Neuropattern in 2000 patients of family doctors, suffering from major depression, depressive episodes, adjustment disorders, and somatoform disorders. The patients receive either unspecific or individualized internet modules in a randomized order.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • native speakers
  • ICD-F diagnoses 32, 33, 43.2, and 45

排除标准

  • patients under glucocorticoid treatment
  • patients taking antidepressants and anxiolytics
  • patients under psychotherapeutic treatment
  • pregnant women
  • severe medical conditions
  • mental retardation
  • arrhythmia absoluta
  • intolerance of dexamethasone

结局指标

主要结局

Documentation and distribution of different endophenotypes (Neuropattern) in patients of family doctors suffering from depressive episodes, major depression, somatoform disorders, and adjustment disorders

时间窗: 15 month

次要结局

  • Efficacy of Neuropattern diagnostics with respect to pharmacological treatments and internet based self-guided psychological modules(1: start of diagnostic testing; 2: after 3 month; 3: after 6 month; 4: after 9 month)

研究者

发起方
University of Trier
申办方类型
Other

研究点 (2)

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