Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT06965868
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT06965868
Study Brief:
Protocol Section:
NCT06965868