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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: University of Trier

Current Primary Outcome: Documentation and distribution of different endophenotypes (Neuropattern) in patients of family doctors suffering from depressive episodes, major depression, somatoform disorders, and adjustment disorders [ Time Frame: 15 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy of Neuropattern diagnostics with respect to pharmacological treatments and internet based self-guided psychological modules [ Time Frame: 1: start of diagnostic testing; 2: after 3 month; 3: after 6 month; 4: after 9 month ]

Original Secondary Outcome: Same as current

Information By: University of Trier

Dates:
Date Received: February 3, 2010
Date Started: February 2010
Date Completion: May 2012
Last Updated: February 3, 2010
Last Verified: October 2009