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