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Could an arthritis drug lift the fog of Treatment-Resistant depression?

NCT ID NCT07052058

Symptom relief Sponsor: Hospital de Clinicas de Porto Alegre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a single infusion of tocilizumab, a drug that blocks the inflammatory molecule IL-6, can reduce depressive symptoms in 32 adults with treatment-resistant major depression. Participants must have high inflammation levels (CRP ≥3 mg/L) and will receive either the drug or a placebo. The study aims to see if targeting inflammation can help when standard antidepressants fail.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tocilizumab
What this could lead to
If it works, this could point toward a new anti-inflammatory option for people with depression that hasn't responded to standard treatments.
What could go wrong
This is a very small early-phase trial with only 32 participants, so results may not apply broadly. The drug also carries risks like infection and allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Baseline HDRS score of 19 or higher at Serum/plasma CRP level ≥3 mg/L Exclusion Criteria: Diagnosis of bipolar disorder or personality disorder History of substance use disorder in the past six months. Presence of active/recent infection (including 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 Active liver disease or transaminase elevation \>1.5× the upper limit of normal Inclusion criteria to the 10 healthy controls recruited for comparison of inflammatory biomarkers: 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

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Treatment-resistant major depressive disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.