Clinical trial NCT01062880: Neuropattern - Assessment of a Translational Diagnostic Tool for Depression, Adjustment- and Somatoform-disorders
Official title: Neuropattern - Clinical Trial of a Psychobiological Stress Diagnostic Tool (Neuropattern - Erprobung Einer Psychobiologischen Stressdiagnostik)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depression
Minor Depression
Somatoform Disorders
Adjustment Disorders
Lead sponsor: University of Trier
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Documentation and distribution of different endophenotypes (Neuropattern) in patients of family doctors suffering from depressive episodes, major depression, somatoform disorders, and adjustment disorders
timeFrame: 15 month
Secondary outcomes:
measure: Efficacy of Neuropattern diagnostics with respect to pharmacological treatments and internet based self-guided psychological modules
timeFrame: 1: start of diagnostic testing; 2: after 3 month; 3: after 6 month; 4: after 9 month
Other outcomes:
Locations:
city: Trier
country: Germany
facility: University of Trier, Department of Psychology, Clinical and Physiological Psychology
Study officials:
affiliation: University of Trier, Dept. of Psychology
name: Dirk H Hellhammer, Professor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hellhammer, D.H., & Hellhammer, J. (Eds.). (2008). Stress: The Brain-Body Connection (Vol. 174). Basel: Karger.
citation: 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.
citation: 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.