Neuropattern - Assessment of a Translational Diagnostic Tool for Depression, Adjustment- and Somatoform-disorders

University of Trier

Status: Unknown

Conditions: Adjustment Disorders; Major Depression; Somatoform Disorders; Minor Depression

Treatments: Behavioral: self-guided internet modules

Study type: Interventional

Funder types: Other

Identifiers

NCT01062880

961-38 62 61 / 891

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind