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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorLeibniz-Institut für Resilienzforschung (LIR) gGmbH

About this trial

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

Eligibility criteria

Qualifiers

Absence of mental disorder diagnosis.

University students.

GHQ-28 > 20

Three or more adverse life events acc. to LE list in the past

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Metformin
  • Placebo

Treatment groups

122 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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