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)

NCT ID: NCT07052058

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2029-07-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tocilizumab

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: BIOLOGICAL

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

Placebo

Group Type: PLACEBO_COMPARATOR

Normal Saline (0.9% NaCl)

Intervention Type: DRUG

Placebo, same volume as 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tocilizumab

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

Intervention Type: BIOLOGICAL

Normal Saline (0.9% NaCl)

Placebo, same volume as intervention

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neusa Sica da Rocha, PhD

Role: STUDY_DIRECTOR

Federal University of Rio Grande do Sul (UFRGS)

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Central Contacts

Neusa Sica da Rocha, PhD

Role: CONTACT

nrocha@hcpa.edu.br

55(51) 3359-8000

Facility Contacts

Neusa Sica da Rocha, PhD

Role: primary

nrocha@hcpa.edu.br

55(51) 3359-8000

Other Identifiers

88904825.7.0000.5327

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0245

Identifier Type: -

Identifier Source: org_study_id