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
Absence of mental disorder diagnosis.
University students.
GHQ-28 > 20
Three or more adverse life events acc. to LE list in the past
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).
Parallel
Metformin
DrugThe 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.
Placebo
DrugThis intervention will be self-administered placebo capsules
Average stressor reactivity (SR) score in the 'early follow-up' study phase
SR is the residual deviation of an individual from the sample's normative relation between stressor exposure (E) and mental health problems (P). A positive residual indicates more mental health problems than expected based on the normative E-P relationship. A negative residual (negative SR score) indicates less mental health problems than expected. Hence, SR is an inverse continuous expression of an individual's resilience.
Whole-brain Blood-Brain Barrier Integrity, assessed with neuroimaging at T0 and T3
A pseudo-continuous ASL (pCASL) MRI sequence will be used to estimate BBB integrity (inverse whole-brain-averaged water exchange rate (kw) from blood to brain tissue).
Average stressor reactivity (SR) score in the 'whole follow-up' study phase
SR is the residual deviation of an individual from the sample's normative relation between stressor exposure (E) and mental health problems (P). A positive residual indicates more mental health problems than expected based on the normative E-P relationship. A negative residual (negative SR score) indicates less mental health problems than expected. Hence, SR is an inverse continuous expression of an individual's resilience.
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Leibniz-Institut für Resilienzforschung (LIR) gGmbH
Lead sponsor
University of Latvia
Collaborator
University of Zurich
Collaborator
Johannes Gutenberg University Mainz
Collaborator
University of Warsaw
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
