Status:
NOT_YET_RECRUITING
Role of the Blood-Brain Barrier in Stress Resilience: Investigating New Pathways Towards Pharmacological Augmentation of Stress Resilience
Lead Sponsor:
Leibniz-Institut für Resilienzforschung (LIR) gGmbH
Collaborating Sponsors:
University of Latvia
University of Zurich
Conditions:
Stress Resilience
Blood-Brain Barrier Integrity
Eligibility:
All Genders
18-25 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to better understand the relationship between blood-brain barrier (BBB) function and stress resilience and to investigate a potential causal role for BBB function in...
Detailed Description
STUDY DESIGN Prospective, randomized, parallel-group, placebo-controlled, double-blind, multi-center experimental study to investigate the relationship between individual variation in BBB integrity a...
Eligibility Criteria
Inclusion
- Inclusion criteria: (participants meeting all of the following criteria will be considered for enrollment in the study)
- Absence of mental disorder diagnosis.
- University students.
- GHQ-28 \> 20
- Three or more adverse life events acc. to LE list in the past
- Beck Depression Inventory (BDI) ≤ 14 \& Columbia-Suicide Severity Rating Scale (C-SSRS) ≤ 1. Thereby concurrent depression and suicidality are excluded.
- Age 18 to 25 years
- Ability of participant to understand character and individual consequences of the study (MMSE Folstein \> 28)
- Signed and dated informed consent of participant
- Exclusion criteria: (participants presenting 1 of the following criteria will not be enrolled in the study)
- Life-time and current diagnosis of any severe mental disorder determined by M.I.N.I. diagnostic interview.
- Known history of brain injuries or neurodevelopmental disorder.
- Evidence of neurodegenerative disorder (e.g., Parkinson).
- Multimorbidity or significant organ (esp. liver or renal) dysfunction or manifest diabetes or substance abuse (esp. alcohol).
- Contraindication to metformin such as renal insufficiency (Creatinin-Clearance\< 60ml/min), recent (\<3 month) ischemic events (e.g. myocardial infarction or stroke).
- Women of childbearing age, who do not practice a medically accepted contraception (i.e., systematic contraceptives, diaphragm, condoms with spermicide, sexual abstinence) during the study and during a 2 years post-study period and who do not present a negative pregnancy test (serum or urine).
- History of hypersensitivity to the study drug, to any drug with similar chemical structure, or to any excipient present in the pharmaceutical form of the study drug.
- Diabetes type 2 (would result in interference with the experimental manipulation)
- Participation in other studies employing a drug during the present study or within the last three months.
- Current use of antidiabetic, weight-loss, or psychoactive medication or substances.
- Pacemaker, implanted medical pumps, implanted cardiac catheters or acute or unstable heart disease (angina pectoris).
- Intracranial implant (aneurysm clips, shunts, stimulators, cochlear implants or electrodes) or other metallic objects inside or near the head (mouth excluded) that cannot be removed.
- Claustrophobia or another contraindication to MRI.
- Insufficient German language skills.
Exclusion
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT06965868
Start Date
June 1 2025
End Date
February 1 2027
Last Update
May 11 2025
Active Locations (3)
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1
Universitätsmedizin der Johannes Gutenberg-Universität Mainz (UM)
Mainz, Rhineland-Palatinate, Germany, 55131
2
University of Warsaw
Warsaw, Poland, 00-927
3
University Zurich (UZH)
Zurich, Switzerland, CH-8032