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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)
Sponsor: Hospital de Clinicas de Porto Alegre
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-08-25
Completion Date
2029-07-29
Last Updated
2025-07-04
Healthy Volunteers
Yes
Interventions
Tocilizumab
Single infusion tocilizumab, 8 mg/kg, diluted in 100 mL of normal saline
Normal Saline (0.9% NaCl)
Placebo, same volume as intervention
Locations (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil