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

Not Applicable

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

• Registration Number: NCT01062880
• Lead Sponsor: University of Trier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study Start: 2010-02
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-03
• Last Update Submitted: 2010-02-03
• Study First Posted: 2010-02-04
• Last Update Posted: 2010-02-04
• Primary Completion: 2011-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Documentation and distribution of different endophenotypes (Neuropattern) in patients of family doctors suffering from depressive episodes, major depression, somatoform disorders, and adjustment disorders	15 month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Trier, Department of Psychology, Clinical and Physiological Psychology; 🇩🇪 Trier, Germany