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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT07052058
Eligibility Criteria:
Inclusion Criteria:
Age ≥ 18 years Provide informed consent Understand written and spoken Portuguese Able and willing to consent to blood sampling Willing to abstain from strenuous exercise for 72 hours prior to assessment Meet DSM-5/MINI criteria for a diagnosis of depression resistant to at least two adequate courses of treatment at the time of eligibility assessment Serum/plasma hsCRP level ≥3 mg/L
Exclusion Criteria:
Diagnosis of bipolar disorder or personality disorder History of substance use disorder in the past six months. Presence of active infection (TB, Hepatitis B, Hepatitis C or HIV) or autoimmune disease Pregnancy or breastfeeding History of significant cardiovascular disease, recent cancer, or hematological disorders BMI \>40 kg/m² or weight \>100 kg Hypersensitivity to tocilizumab or any of its excipients. CRP ≥20 mg/L
Inclusion criteria to the 10 healthy controls recruited for comparison of inflammatory biomarkers:
Age ≥ 18 No current or lifetime psychiatric diagnosis, as measured by the SRQ-20 Provide informed consent Understand written and spoken Portuguese Able and willing to consent to blood sampling
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07052058
Study Brief:
Protocol Section:
NCT07052058