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

NCT01062880 | Unknown DMC

• 1 other identifier: 961-38 62 61 / 891
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression; Minor Depression; Somatoform Disorders; Adjustment Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

self-guided internet modules BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Trier: lead

Study Sites (1)

University of Trier, Department of Psychology, Clinical and Physiological Psychology

Trier, 54290, Germany

RECRUITING

Related Publications (3)

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

  BACKGROUND

• Kumsta R, Kliegel D, Linden M, DeRijk R, de Kloet ER. Genetic variation of the mineralocorticoid receptor gene (MR, NR3C2) is associated with a conceptual endophenotype of "CRF-hypoactivity". Psychoneuroendocrinology. 2019 Jul;105:79-85. doi: 10.1016/j.psyneuen.2018.09.036. Epub 2018 Sep 27.

  PMID: 30292651 DERIVED

• Vogt D, Waeldin S, Hellhammer D, Meinlschmidt G. The role of early adversity and recent life stress in depression severity in an outpatient sample. J Psychiatr Res. 2016 Dec;83:61-70. doi: 10.1016/j.jpsychires.2016.08.007. Epub 2016 Aug 7.

  PMID: 27566836 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Somatoform Disorders; Adjustment Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Trauma and Stressor Related Disorders

Study Officials

• Dirk H Hellhammer, Professor, PhD

  University of Trier, Dept. of Psychology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk H Hellhammer, Professor PhD

CONTACT

+49-651-201; hellhamm@uni-trier.de

Maria Conrad, Secretary

CONTACT

+49-651-201; conradm@uni-trier.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2012
• Last Updated: February 4, 2010

Record last verified: 2009-10

Locations

DE (1)