Major DepressionNeuropatternNCT01062880
Neuropattern - Assessment of a Translational Diagnostic Tool for Depression, Adjustment- and Somatoform-disorders
A study testing self-guided internet modules in people with Major Depression and Minor Depression, run by University of Trier at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression, Minor Depression, Somatoform Disorders
- What is being tested?
- self-guided internet modules
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- native speakers
- ICD-F diagnoses 32, 33, 43.2, and 45
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Trier, Department of Psychology, Clinical and Physiological Psychology
Trier, 54290
Christel Neu, +49-651-201 ext. 3211, neu@uni-trier.de
Sabine Albertz, MSc, +49-651-201 ext. 2989, albertz@uni-trier.de
About this study
Official title: 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.
- Being tested
- self-guided internet modules
- Medical subject headings
- Depressive Disorder, Major, Somatoform Disorders, Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-guided internet modulesBehavioural
Patients are assigned at random to either unspecific (n= 1000) or individualized (n=1000) self guided internet modules.
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation and distribution of different endophenotypes (Neuropattern) in patients of family doctors suffering from depressive episodes, major depression, somatoform disorders, and adjustment disorders
Measured: 15 month
Secondary outcomes (1)
Efficacy of Neuropattern diagnostics with respect to pharmacological treatments and internet based self-guided psychological modules
Measured: 1: start of diagnostic testing; 2: after 3 month; 3: after 6 month; 4: after 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2011 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Trier
- Sponsor type
- University, hospital or other
- Investigators
- Dirk H Hellhammer, Professor, PhD, Principal investigator, University of Trier, Dept. of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062880
- Sponsor's protocol ID
- 961-38 62 61 / 891
- Acronym
- Neuropattern
- Status last verified
- Oct 2009
- First submitted
- 3 Feb 2010
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 30292651Vogt 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.
PubMed 27566836
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropattern - Clinical Trial of a Psychobiological Stress Diagnostic Tool (Neuropattern - Erprobung Einer Psychobiologischen Stressdiagnostik)
- ClinicalTrials.gov ID
- NCT01062880
- Acronym / sponsor ID
- Neuropattern / 961-38 62 61 / 891
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of TrierUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- native speakers
- ICD-F diagnoses 32, 33, 43.2, and 45
Key exclusion criteria (8 listed)
- patients under glucocorticoid treatment
- patients taking antidepressants and anxiolytics
- patients under psychotherapeutic treatment
- pregnant women
- severe medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-guided internet modulesPatients are assigned at random to either unspecific (n= 1000) or individualized (n=1000) self guided internet modules. | Behavioural | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
- BackgroundHellhammer, D.H., & Hellhammer, J. (Eds.). (2008). Stress: The Brain-Body Connection (Vol. 174). Basel: Karger.
- Derived from this study: PubMed 30292651Kumsta 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.
- Derived from this study: PubMed 27566836Vogt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk H Hellhammer, Professor, PhD principal investigator
University of Trier, Dept. of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-guided internet modules in people with Major Depression and Minor Depression, run by University of Trier at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dirk H Hellhammer, Professor PhD (+49-651-201 ext. 2928, hellhamm@uni-trier.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01062880, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2010.