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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01062880
Recruitment Status : Unknown
Verified October 2009 by University of Trier.
Recruitment status was:  Recruiting
First Posted : February 4, 2010
Last Update Posted : February 4, 2010
Information provided by:
University of Trier

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.

Condition or disease Intervention/treatment Phase
Major Depression Minor Depression Somatoform Disorders Adjustment Disorders Behavioral: self-guided internet modules Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Neuropattern - Clinical Trial of a Psychobiological Stress Diagnostic Tool (Neuropattern - Erprobung Einer Psychobiologischen Stressdiagnostik)
Study Start Date : February 2010
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Behavioral: self-guided internet modules
    Patients are assigned at random to either unspecific (n= 1000) or individualized (n=1000) self guided internet modules.

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01062880

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Contact: Dirk H Hellhammer, Professor PhD +49-651-201 ext 2928
Contact: Maria Conrad, Secretary +49-651-201 ext 2929

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University of Trier, Department of Psychology, Clinical and Physiological Psychology Recruiting
Trier, Germany, 54290
Contact: Christel Neu    +49-651-201 ext 3211   
Contact: Sabine Albertz, MSc    +49-651-201 ext 2989   
Principal Investigator: Dirk H Hellhammer, Professor, PhD         
Sub-Investigator: Friedemann Gerhards, PhD         
Sponsors and Collaborators
University of Trier
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Principal Investigator: Dirk H Hellhammer, Professor, PhD University of Trier, Dept. of Psychology
Hellhammer, D.H., & Hellhammer, J. (Eds.). (2008). Stress: The Brain-Body Connection (Vol. 174). Basel: Karger.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. Dirk H. Hellhammer, University of Trier, Dept of Psychology, Div Clinical and Physiol Psychology Identifier: NCT01062880    
Other Study ID Numbers: 961-38 62 61 / 891
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: October 2009
Additional relevant MeSH terms:
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Depressive Disorder
Adjustment Disorders
Somatoform Disorders
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Trauma and Stressor Related Disorders