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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Trier.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Trier
ClinicalTrials.gov Identifier:
NCT01062880
First received: February 3, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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 Intervention
Major Depression
Minor Depression
Somatoform Disorders
Adjustment Disorders
Behavioral: self-guided internet modules

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Neuropattern - Clinical Trial of a Psychobiological Stress Diagnostic Tool (Neuropattern - Erprobung Einer Psychobiologischen Stressdiagnostik)

Resource links provided by NLM:


Further study details as provided by University of Trier:

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 [ Time Frame: 15 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: February 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062880

Contacts
Contact: Dirk H Hellhammer, Professor PhD +49-651-201 ext 2928 hellhamm@uni-trier.de
Contact: Maria Conrad, Secretary +49-651-201 ext 2929 conradm@uni-trier.de

Locations
Germany
University of Trier, Department of Psychology, Clinical and Physiological Psychology Recruiting
Trier, Germany, 54290
Contact: Christel Neu    +49-651-201 ext 3211    neu@uni-trier.de   
Contact: Sabine Albertz, MSc    +49-651-201 ext 2989    albertz@uni-trier.de   
Principal Investigator: Dirk H Hellhammer, Professor, PhD         
Sub-Investigator: Friedemann Gerhards, PhD         
Sponsors and Collaborators
University of Trier
Investigators
Principal Investigator: Dirk H Hellhammer, Professor, PhD University of Trier, Dept. of Psychology
  More Information

Additional Information:
Publications:
Hellhammer, D.H., & Hellhammer, J. (Eds.). (2008). Stress: The Brain-Body Connection (Vol. 174). Basel: Karger.

Responsible Party: Prof. Dr. Dirk H. Hellhammer, University of Trier, Dept of Psychology, Div Clinical and Physiol Psychology
ClinicalTrials.gov Identifier: NCT01062880     History of Changes
Other Study ID Numbers: 961-38 62 61 / 891
Study First Received: February 3, 2010
Last Updated: February 3, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Adjustment Disorders
Depression
Depressive Disorder
Somatoform Disorders
Depressive Disorder, Major
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 29, 2014