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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06243783
Other study ID # PSY-NIL-0012
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date February 29, 2028

Study information

Verified date January 2024
Source Medical University of Vienna
Contact Andreas Hahn, Assoc.Prof.
Phone +43140400
Email andreas.hahn@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Stress plays an essential role in the pathophysiology of mental disorders. However, individual differences in the vulnerability to acute and repeated stress are not well understood. Aim: This work aims to investigate individual differences in glucose metabolism and directional connectivity regulating the neuronal stress response. Design: 68 healthy volunteers will undergo two simultaneous PET/MRI measurements one week apart. Participants will complete the Montreal Imaging Stress Test during each measurement and in-between. Effects of stress on cognitive performance will be assessed using the n-back working memory task. Individual cortisol levels will be acquired to identify stress (non)responders as well as (non)habituators. Implications: This work will characterize differences between stress responders vs. non-responders and stress habituators vs. non-habituators in terms of energy metabolism and network connectivity. This individual difference in the stress response may represent an important cornerstone for future evaluation of patients with mental disorders.


Description:

Methodological details: Each participant will undergo two PET/MRI scans. Imaging will include functional PET and as well as structural and functional MRI. Stress-specific glucose metabolism will be quantified with the radioligand [18F]FDG. Functional connectivity will be combined with glucose metabolism to assess directional connectivity.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 68
Est. completion date February 29, 2028
Est. primary completion date February 29, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 18-40 years - right-handedness - willingness and competence to sign the informed consent form Exclusion Criteria: - History of or current physical, neurological or psychiatric disorder - History of or current substance abuse or medication, including antipsychotic, antidepressant and antianxiety agents - Pregnancy of current breast-feeding - Contraindications for MRI-scanning (e.g., metal implants, steel grafts, etc.), including dental implants causing signal artifacts - For subjects participating in earlier studies using ionizing radiation, the total radiation exposure of 30 mSv over the last 10 years must not be exceeded, as specified in the Austrian legislation on radiation protection Accordingly, body weight > 105 kg is an exclusion criterion. - Failure to comply with the study protocol or to follow the instructions of the investigating team.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Montreal Imaging Stress Test
In the Montreal Imaging Stress Test, participants are required to solve basic mathematical tasks, but the allowed reaction time is set lower than their average.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Rupert Lanzenberger University of Konstanz

Outcome

Type Measure Description Time frame Safety issue
Primary Stress induced changes in glucose metabolism Glucose metabolism will be quantified from [18F]FDG PET imaging. 1 week
Secondary Stress induced changes in directional connectivity Directional connectivity will be computed as combination of MRI-based functional connectivity and glucose metabolism. 1 week
Secondary Stress induced changes in cognitive performance Cognitive performance will be obtained by the n-back working memory task. 1 week
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