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.
Placebo: This intervention will be self-administered placebo capsules
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
25 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Average stressor reactivity (SR) score in the 'early follow-up' study phase — From week 13 after enrollment (T4) until week 24 after enrollment (T6) 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.
Trial sites (3)
Facility
City
Region
Status
Universitätsmedizin der Johannes Gutenberg-Universität Mainz (UM)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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