- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01062880
Neuropattern - Assessment of a Translational Diagnostic Tool for Depression, Adjustment- and Somatoform-disorders (Neuropattern)
February 3, 2010 updated by: University of Trier
Neuropattern - Clinical Trial of a Psychobiological Stress Diagnostic Tool (Neuropattern - Erprobung Einer Psychobiologischen Stressdiagnostik)
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
2000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dirk H Hellhammer, Professor PhD
- Phone Number: 2928 +49-651-201
- Email: hellhamm@uni-trier.de
Study Contact Backup
- Name: Maria Conrad, Secretary
- Phone Number: 2929 +49-651-201
- Email: conradm@uni-trier.de
Study Locations
-
-
-
Trier, Germany, 54290
- Recruiting
- University of Trier, Department of Psychology, Clinical and Physiological Psychology
-
Contact:
- Christel Neu
- Phone Number: 3211 +49-651-201
- Email: neu@uni-trier.de
-
Contact:
- Sabine Albertz, MSc
- Phone Number: 2989 +49-651-201
- Email: albertz@uni-trier.de
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Principal Investigator:
- Dirk H Hellhammer, Professor, PhD
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Sub-Investigator:
- Friedemann Gerhards, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
15 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1: start of diagnostic testing; 2: after 3 month; 3: after 6 month; 4: after 9 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dirk H Hellhammer, Professor, PhD, University of Trier, Dept. of Psychology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hellhammer, D.H., & Hellhammer, J. (Eds.). (2008). Stress: The Brain-Body Connection (Vol. 174). Basel: Karger.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Anticipated)
May 1, 2011
Study Completion (Anticipated)
May 1, 2012
Study Registration Dates
First Submitted
February 3, 2010
First Submitted That Met QC Criteria
February 3, 2010
First Posted (Estimate)
February 4, 2010
Study Record Updates
Last Update Posted (Estimate)
February 4, 2010
Last Update Submitted That Met QC Criteria
February 3, 2010
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 961-38 62 61 / 891
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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