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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)

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Jul 29, 2029 to Jul 1, 2028v2 Show 4 more changesShow less
    • Start date: Aug 25, 2025 to Jul 1, 2026
    • Primary endpoints: 4 to 1
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 5 to 11
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07052058
Lead Sponsor Hospital de Clinicas de Porto Alegre
Conditions
(from sponsor)		 Treatment-Resistant Major Depressive Disorder
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov