Last updated 45 days ago
Triple-Blind Randomized Clinical Trial of Tocilizumab vs Placebo: Potential Use of an IL-6 Antagonist as an Adjuvant to Standard Treatment for Treatment-Resistant Major Depression in the Brazilian Public Health System (SUS)
32 patients around the world
Available in Brazil
Hospital de Clinicas de Porto Alegre
1Research sites
32Patients around the world
This study is for people with
Depression
Major depression
Requirements for the patient
To 65 Years
All Gender
Medical requirements
- 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.Inclusion criteria to the 10 healthy controls recruited for comparison of inflammatory biomarkers:1. Age ≥ 182. No current or lifetime psychiatric diagnosis, as measured by the SRQ-20.3. Provide informed consent4. Understand written and spoken Portuguese.5. Able and willing to consent to blood sampling.
- 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.
Sites
Hospital de Clínicas de Porto Alegre
SponsorHospital de Clinicas de Porto Alegre
Study typeInterventional
Conditions
Major depression
Requirements
To 65 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07052058
