Neuropattern - Assessment of a Translational Diagnostic Tool for Depression, Adjustment- and Somatoform-disorders (Neuropattern)
Primary Purpose
Major Depression, Minor Depression, Somatoform Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
self-guided internet modules
Sponsored by
About this trial
This is an interventional diagnostic trial for Major Depression
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
Sites / Locations
- University of Trier, Department of Psychology, Clinical and Physiological PsychologyRecruiting
Outcomes
Primary Outcome Measures
Documentation and distribution of different endophenotypes (Neuropattern) in patients of family doctors suffering from depressive episodes, major depression, somatoform disorders, and adjustment disorders
Secondary Outcome Measures
Efficacy of Neuropattern diagnostics with respect to pharmacological treatments and internet based self-guided psychological modules
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01062880
Brief Title
Neuropattern - Assessment of a Translational Diagnostic Tool for Depression, Adjustment- and Somatoform-disorders
Acronym
Neuropattern
Official Title
Neuropattern - Clinical Trial of a Psychobiological Stress Diagnostic Tool (Neuropattern - Erprobung Einer Psychobiologischen Stressdiagnostik)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Trier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Minor Depression, Somatoform Disorders, Adjustment Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
self-guided internet modules
Intervention Description
Patients are assigned at random to either unspecific (n= 1000) or individualized (n=1000) self guided internet modules.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dirk H Hellhammer, Professor PhD
Phone
+49-651-201
Ext
2928
Email
hellhamm@uni-trier.de
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Conrad, Secretary
Phone
+49-651-201
Ext
2929
Email
conradm@uni-trier.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk H Hellhammer, Professor, PhD
Organizational Affiliation
University of Trier, Dept. of Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Trier, Department of Psychology, Clinical and Physiological Psychology
City
Trier
ZIP/Postal Code
54290
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christel Neu
Phone
+49-651-201
Ext
3211
Email
neu@uni-trier.de
First Name & Middle Initial & Last Name & Degree
Sabine Albertz, MSc
Phone
+49-651-201
Ext
2989
Email
albertz@uni-trier.de
First Name & Middle Initial & Last Name & Degree
Dirk H Hellhammer, Professor, PhD
First Name & Middle Initial & Last Name & Degree
Friedemann Gerhards, PhD
12. IPD Sharing Statement
Citations:
Citation
Hellhammer, D.H., & Hellhammer, J. (Eds.). (2008). Stress: The Brain-Body Connection (Vol. 174). Basel: Karger.
Results Reference
background
PubMed Identifier
30292651
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.
Results Reference
derived
PubMed Identifier
27566836
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.
Results Reference
derived
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Neuropattern - Assessment of a Translational Diagnostic Tool for Depression, Adjustment- and Somatoform-disorders
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