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
Study ID
NCT07052058
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Treatment-Resistant Major Depressive Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Tocilizumab — BIOLOGICAL
    Single infusion tocilizumab, 8 mg/kg, diluted in 100 mL of normal saline
  • Normal Saline (0.9% NaCl) — DRUG
    Placebo, same volume as intervention

Study Details

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 Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
  • Placebo Comparator: Placebo
  • No Intervention: Healthy controls, for comparison of inflammatory biomarkers
    Healthy controls (HCs) will be recruited for comparison of CRP and IL-6 levels. They will be required to have no current or past history of psychiatric disorders as assessed by the SRQ-20, an instrument developed by the WHO to measure the level of suspicion of mental disorders.

Primary Outcome Measure

Reduction in depressive symptoms (HDRS) [ Time Frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6) ]

Central Contacts

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