NCT07052058

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Treatment-Resistant Major Depressive Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-25
• Primary completion: 2029-07-29
• Completion: 2029-07-29
• First posted: 2025-07-04
• Last updated: 2025-07-04

Locations

1 site across 1 country: Brazil