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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT05745194
Eligibility Criteria:
Inclusion Criteria:
1. Aged between 18-70 years old
2. Able to understand and provide informed consent
3. Able to read and write
4. Have a diagnosis of MDD (according to ICD-10 F32.0; F32.1; F32.2; F32.9; F33.0; F33.1; F33.2; F33.9 criteria)
5. Score on the Beck Depression Inventory-II scale (BDI-II) \> 13;
6. Elevated biomarkers of inflammation (CRP \> 3mg/l or IL-6 ≥ 2pg/ml )
7. Able to follow a MedDiet without impeditive physical or religious limitations, allergies or intolerances
8. Being under pharmacological treatment for depressive disorder
Exclusion Criteria:
1. Diagnosis of autoimmune diseases, thyroid dysfunction or cancer
2. Diagnosis of bipolar disorder, psychotic disorders, eating disorders
3. Self-reported acute infection 2 weeks prior to the blood sample collection
4. Pregnancy or lactation
5. Glucocorticoid medication
6. Prescribed with NMDA Receptor Antagonists
7. Under treatment with brain stimulation techniques for the depressive episode
8. Currently participating in another intervention targeting diet, physical exercise, or MDD treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05745194
Study Brief:
Protocol Section:
NCT05745194