StressNCT06243783
Impact of Stress on Brain Energy Metabolism
A study testing Montreal Imaging Stress Test in people with Stress, run by Rupert Lanzenberger at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Montreal Imaging Stress Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2024to 29 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years
- right-handedness
- willingness and competence to sign the informed consent form
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna
Rupert Lanzenberger, Prof, +43140400 ext. 35760, rupert.lanzenberger@meduniwien.ac.at
Andreas Hahn, Assoc Prof
About this study
Official title: Impact of Acute Stress and Its Habituation on Brain Energy Metabolism
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.
Read more
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.
Read the detailed 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. Based on previous literature, changes are expected to occur in the anterior cingulate cortex.
- Conditions
- Stress
- Being tested
- Montreal Imaging Stress Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montreal Imaging Stress TestBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress | Experimental | Montreal Imaging Stress Test during each PET/MRI measurement and in-between Receives: Behavioral: Montreal Imaging Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress induced changes in glucose metabolism
Glucose metabolism will be quantified from [18F]FDG PET imaging.
Measured: 1 week
Secondary outcomes (2)
Stress induced changes in directional connectivity
Directional connectivity will be computed as combination of MRI-based functional connectivity and glucose metabolism.
Measured: 1 week
Stress induced changes in cognitive performance
Cognitive performance will be obtained by the n-back working memory task.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Mar 2024
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rupert Lanzenberger
- Sponsor type
- University, hospital or other
- Collaborators
- University of Konstanz
- Responsible party
- Sponsor-investigator, Rupert Lanzenberger, Medical University of Vienna
- Investigators
- Andreas Hahn, Assoc.Prof., Principal investigator, Department of Psychiatry and Psychtherapy, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243783
- Sponsor's protocol ID
- PSY-NIL-0012
- Status last verified
- Dec 2025
- First submitted
- 29 Jan 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be deposited on datadryad.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Stress and Its Habituation on Brain Energy Metabolism
- ClinicalTrials.gov ID
- NCT06243783
- Acronym / sponsor ID
- PSY-NIL-0012
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Rupert LanzenbergerUniversity, hospital or other
- Collaborators
- University of Konstanz
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 6 Feb 2024 (actual)
- 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.
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.
Detailed 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. Based on previous literature, changes are expected to occur in the anterior cingulate cortex.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress | Experimental | Behavioral: Montreal Imaging Stress TestMontreal Imaging Stress Test during each PET/MRI measurement and in-between |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-40 years
- right-handedness
- willingness and competence to sign the informed consent form
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Montreal Imaging Stress TestIn the Montreal Imaging Stress Test, participants are required to solve basic mathematical tasks, but the allowed reaction time is set lower than their average. | Behavioural | Stress |
Primary outcome
Stress induced changes in glucose metabolism
Time frame: 1 week
Glucose metabolism will be quantified from [18F]FDG PET imaging.
2 secondary outcomes
Stress induced changes in directional connectivity
Time frame: 1 week
Stress induced changes in cognitive performance
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Neuroimaging Labs, Dept. of Psychiatry and Psychotherapy, Medical University of ViennaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized data will be deposited on datadryad.
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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.
Andreas Hahn, Assoc.Prof. principal investigator
Department of Psychiatry and Psychtherapy, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montreal Imaging Stress Test in people with Stress, run by Rupert Lanzenberger at 1 site in Austria.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Hahn, Assoc.Prof. (+43140400 ext. 23200, andreas.hahn@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress induced changes in glucose metabolism (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2025.