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

Major Depression Clinical Trial

— Neuropattern  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01062880
• Other study ID #: 961-38 62 61 / 891
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2010
• Last updated: February 3, 2010
• Start date: February 2010
• Est. completion date: May 2012

Study information

• Verified date: October 2009
• Source: University of Trier
• Contact: Dirk H Hellhammer, Professor PhD
• Phone: +49-651-201
• Email: hellhamm[@]uni-trier.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adjustment Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depression
• Minor Depression
• Somatoform Disorders

Intervention

Behavioral:
• self-guided internet modules
Patients are assigned at random to either unspecific (n= 1000) or individualized (n=1000) self guided internet modules.

Locations

Country	Name	City	State
Germany	University of Trier, Department of Psychology, Clinical and Physiological Psychology	Trier

Sponsors (1)

Lead Sponsor	Collaborator
University of Trier

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hellhammer, D.H., & Hellhammer, J. (Eds.). (2008). Stress: The Brain-Body Connection (Vol. 174). Basel: Karger.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   principal investigator website: List of Publications