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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01062880
Acronym
Neuropattern
Enrollment
2000
Registered
2010-02-04
Start date
2010-02-28
Completion date
2012-05-31
Last updated
2010-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjustment Disorders, Major Depression, Minor Depression, Somatoform Disorders

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.

Interventions

BEHAVIORALself-guided internet modules

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

Sponsors

University of Trier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Documentation and distribution of different endophenotypes (Neuropattern) in patients of family doctors suffering from depressive episodes, major depression, somatoform disorders, and adjustment disorders15 month

Secondary

MeasureTime frame
Efficacy of Neuropattern diagnostics with respect to pharmacological treatments and internet based self-guided psychological modules1: start of diagnostic testing; 2: after 3 month; 3: after 6 month; 4: after 9 month

Countries

Germany

Contacts

Primary ContactDirk H Hellhammer, Professor PhD
hellhamm@uni-trier.de+49-651-201
Backup ContactMaria Conrad, Secretary
conradm@uni-trier.de+49-651-201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026