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)

NCT07052058 | Not Yet Recruiting Phase 2

• 2 other identifiers: 2025-024588904825.7.0000.5327
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Clinical global improvement (CGI)

  Baseline and follow-ups (day 7, day 14, day 28 and month 6)

• Reduction in depressive symptoms (HDRS)

  Baseline and follow-ups (day 7, day 14, day 28 and month 6)

• General psychiatric symptoms improvement (BPRS)

  Baseline and follow-ups (day 7, day 14, day 28 and month 6)

• ECT indication after invervention

  Follow-ups (day 7, day 14, day 28 and month 6)

Secondary Outcomes (5)

• Cognitive performance (Montreal Cognitive Test)

  Baseline and follow-ups (day 7, day 14, day 28 and month 6)

• Quality of life (EUROHISQOL8)

  Baseline and follow-ups (day 7, day 14, day 28 and month 6)

• Psychiatric hospitalization rate in 6 months

  6 months follow-up

• Suicidal ideation (MINI)

  Elegibility and follow-ups (day 7, day 14, day 28 and month 6)

• Quality of life (WHOQOL-BREF)

  Baseline, follow-ups (day 7, day 14, day 28 and month 6)

Study Arms (3)

Tocilizumab

EXPERIMENTAL

Biological: Tocilizumab

Placebo

PLACEBO COMPARATOR

Drug: Normal Saline (0.9% NaCl)

Healthy controls, for comparison of inflammatory biomarkers

NO INTERVENTION

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.

Interventions

Tocilizumab BIOLOGICAL

Single infusion tocilizumab, 8 mg/kg, diluted in 100 mL of normal saline

Tocilizumab

Normal Saline (0.9% NaCl) DRUG

Placebo, same volume as intervention

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Serum/plasma hsCRP level ≥3 mg/L

You may not qualify if:

• Diagnosis of bipolar disorder or personality disorder History of substance use disorder in the past six months. Presence of active infection (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
• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Interventions

tocilizumab; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Neusa Sica da Rocha, PhD

  Federal University of Rio Grande do Sul (UFRGS)

  STUDY DIRECTOR

Central Study Contacts

Neusa Sica da Rocha, PhD

CONTACT

55(51) 3359-8000; nrocha@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): July 29, 2029
• Study Completion (Estimated): July 29, 2029
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)