NCT06243783

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Mar 2024Feb 2028

First Submitted

Initial submission to the registry

January 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2028

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

4 years

First QC Date

January 29, 2024

Last Update Submit

December 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stress induced changes in glucose metabolism

    Glucose metabolism will be quantified from \[18F\]FDG PET imaging.

    1 week

Secondary Outcomes (2)

  • Stress induced changes in directional connectivity

    1 week

  • Stress induced changes in cognitive performance

    1 week

Study Arms (1)

Stress

EXPERIMENTAL

Montreal Imaging Stress Test during each PET/MRI measurement and in-between

Behavioral: Montreal Imaging Stress Test

Interventions

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.

Stress

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • right-handedness
  • willingness and competence to sign the informed consent form

You may not qualify if:

  • 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
  • Failure to comply with the study protocol or to follow the instructions of the investigating team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, Austria

RECRUITING

Related Links

Study Officials

  • Andreas Hahn, Assoc.Prof.

    Department of Psychiatry and Psychtherapy, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Hahn, Assoc.Prof.

CONTACT

Rupert Lanzenberger, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. PD MD, Head Neuroimaging Labs

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 6, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

February 29, 2028

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Anonymized data will be deposited on datadryad.

Time Frame
After study completion.
Access Criteria
Public access.

Locations