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NCT06965868

Role of the Blood-Brain Barrier in Stress Resilience: Investigating New Pathways Towards Pharmacological Augmentation of Stress Resilience

Sponsor: Leibniz-Institut für Resilienzforschung (LIR) gGmbH

View on ClinicalTrials.gov

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 stress resilience in humans. The researchers will look for particpants that are young adults to answer the following questions to reach our goal: * Is better BBB integrity, measured with neuroimaging, associated with better stress resilience in the short term and in the long term? * Does the administration of Metformin improve BBB integrity? * Is improved BBB integrity a possible link between Metformin and better short- and long-term stress resilience? The participants will do the following during our study: * Participants will fill in online surveys on stressor exposure and mental health once every four weeks over 36 weeks * Participants will visit the study site 4 times: * The first time for a screening process which includes questionnaires, a medical exam and a blood sample. * The next 2 visits will include a blood sample, a medical exam, an MRI scan and a list of questionnaires * The last visit will include another blood sample, a medical exam and a list of questionnaires. * Between visit 2 and 3, the participant will take either Metformin or Placebo

Official title: Role of the Blood-Brain Barrier in Stress Resilience: Investigating New Pathways Towards Pharmacological Augmentation of Stress Resilience (a PHASR-PP Project Study)

Key Details

Gender

All

Age Range

18 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2025-06

Completion Date

2027-02

Last Updated

2025-05-11

Healthy Volunteers

Yes

Conditions

Stress Resilience Blood-Brain Barrier Integrity Mental Health

Interventions

DRUG

Metformin

The Metformin intervention will be self-administred capsules, taken during a 12-week period: Four weeks of dose increase; first and second week 500 mg once daily, third and fourth week 500mg twice daily. Full-dose administration (850 mg twice daily) for eight weeks.

DRUG

Placebo

This intervention will be self-administered placebo capsules

Inclusion criteria: (participants meeting all of the following criteria will be considered for enrollment in the study) 1. Absence of mental disorder diagnosis. 2. University students. 3. GHQ-28 \> 20 4. Three or more adverse life events acc. to LE list in the past 5. Beck Depression Inventory (BDI) ≤ 14 \& Columbia-Suicide Severity Rating Scale (C-SSRS) ≤ 1. Thereby concurrent depression and suicidality are excluded. 6. Age 18 to 25 years 7. Ability of participant to understand character and individual consequences of the study (MMSE Folstein \> 28) 8. Signed and dated informed consent of participant Exclusion criteria: (participants presenting 1 of the following criteria will not be enrolled in the study) 1. Life-time and current diagnosis of any severe mental disorder determined by M.I.N.I. diagnostic interview. 2. Known history of brain injuries or neurodevelopmental disorder. 3. Evidence of neurodegenerative disorder (e.g., Parkinson). 4. Multimorbidity or significant organ (esp. liver or renal) dysfunction or manifest diabetes or substance abuse (esp. alcohol). 5. Contraindication to metformin such as renal insufficiency (Creatinin-Clearance\< 60ml/min), recent (\<3 month) ischemic events (e.g. myocardial infarction or stroke). 6. 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). 7. 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. 8. Diabetes type 2 (would result in interference with the experimental manipulation) 9. Participation in other studies employing a drug during the present study or within the last three months. 10. Current use of antidiabetic, weight-loss, or psychoactive medication or substances. 11. Pacemaker, implanted medical pumps, implanted cardiac catheters or acute or unstable heart disease (angina pectoris). 12. 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. 13. Claustrophobia or another contraindication to MRI. 14. Insufficient German language skills.

Locations (3)

Universitätsmedizin der Johannes Gutenberg-Universität Mainz (UM)

Mainz, Rhineland-Palatinate, Germany

University of Warsaw

Warsaw, Poland

University Zurich (UZH)

Zurich, Switzerland