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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tocilizumab, Normal Saline (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Treatment-Resistant Major Depressive Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Clinical trial aimed at evaluating whether a single infusion of tocilizumab, a medication that blocks the action of an inflammatory molecule called interleukin-6 (IL-6), can reduce symptoms of treatment-resistant major depression compared to placebo in non-hospitalized patients.
Interventions
- Biological Tocilizumab
Single infusion tocilizumab, 8 mg/kg, diluted in 100 mL of normal saline - Drug Normal Saline (0.9% NaCl)
Placebo, same volume as intervention
Primary outcome measures
- Reduction in depressive symptoms (HDRS) [Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)]
Secondary outcome measures (11)
- Cognitive performance (Montreal Cognitive Test) [Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)]
- Quality of life (EUROHISQOL8) [Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)]
- BDNF levels [Time frame: Baseline and third follow-up post-intervention (28th day)]
- ECT indication after invervention [Time frame: Follow-ups (day 7, day 14, day 28 and month 6)]
- General psychiatric symptoms improvement (BPRS) [Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)]
- Clinical global improvement (CGI) [Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)]
- CRP levels [Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)]
- IL-6 levels [Time frame: Baseline (for healthy controls) and baseline and follow-ups for intervention arm(day 7, day 14, day 28 and month 6)]
- Psychiatric hospitalization rate in 6 months [Time frame: 6 months follow-up]
- Suicidal ideation (MINI) [Time frame: Elegibility and follow-ups (day 7, day 14, day 28 and month 6)]
- Quality of life (WHOQOL-BREF) [Time frame: Baseline, follow-ups (day 7, day 14, day 28 and month 6)]
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 Baseline HDRS score of 19 or higher at Serum/plasma CRP 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/recent infection (including 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 Active liver disease or transaminase elevation >1.5× the upper limit of normal
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Hospital de Clínicas de Porto Alegre — Porto Alegre
Publications
- Portal PHG, Peixoto GN, de Matos MR, da Silva LCN, Alexandrino GB, Dutra PHG, Carniel BP, da Rocha NS. Add-on tocilizumab versus placebo for resistant major depression in psychiatric outpatients with low-grade inflammation in a tertiary public hospital in Southern Brazil: randomised triple-blind clinical trial protocol. BMJ Open. 2026 Jun 12;16(6):e111421. doi: 10.1136/bmjopen-2025-111421. PMID 42285573
Identifiers
NCT: NCT07052058 · 2025-0245 · 88904825.7.0000.5327