Treatment-Resistant Major Depressive DisorderPhase 2NCT07052058
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)
A Phase 2 study testing Tocilizumab and Normal Saline (0.9% NaCl) in people with Treatment-Resistant Major Depressive Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment-Resistant Major Depressive Disorder
- What is being tested?
- Tocilizumab and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Neusa Sica da Rocha, PhD, 55(51) 3359-8000, nrocha@hcpa.edu.br
About this study
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.
- Being tested
- Tocilizumab, Normal Saline (0.9% NaCl)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabBiological
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 group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Not described Receives: Biological: Tocilizumab |
| Placebo | Placebo comparator | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in depressive symptoms (HDRS)
≥50% reduction in score
Measured: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
Secondary outcomes (11)
Cognitive performance (Montreal Cognitive Test)
Measured: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
Quality of life (EUROHISQOL8)
Measured: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
BDNF levels
Serum Brain-Derived Neurotrophic Factor level
Measured: Baseline and third follow-up post-intervention (28th day)
ECT indication after invervention
Measured: Follow-ups (day 7, day 14, day 28 and month 6)
General psychiatric symptoms improvement (BPRS)
Measured: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
Clinical global improvement (CGI)
Measured: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
CRP levels
Serum C-Reactive Protein levels
Measured: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
IL-6 levels
Serum IL-6
Measured: Baseline (for healthy controls) and baseline and follow-ups for intervention arm(day 7, day 14, day 28 and month 6)
Psychiatric hospitalization rate in 6 months
Measured: 6 months follow-up
Suicidal ideation (MINI)
Measured: Elegibility and follow-ups (day 7, day 14, day 28 and month 6)
Quality of life (WHOQOL-BREF)
Measured: Baseline, follow-ups (day 7, day 14, day 28 and month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment-Resistant Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neusa Sica da Rocha, PhD, Study director, Federal University of Rio Grande do Sul (UFRGS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052058
- Sponsor's protocol ID
- 2025-0245
- Other IDs
- 88904825.7.0000.5327
- Status last verified
- May 2026
- First submitted
- 26 Jun 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Portal PHG, Peixoto GN, de Matos MR, da Silva LCN, Alexandrino GB, Dutra PHG, Carniel BP, da Rocha NS. Add-on tocilizumab versus placebo for resistant major depression in psychiatric outpatients with low-grade inflammation in a tertiary public hospital in Southern Brazil: randomised triple-blind clinical trial protocol. BMJ Open. 2026 Jun 12;16(6):e111421. doi: 10.1136/bmjopen-2025-111421.
PubMed 42285573
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07052058
- Acronym / sponsor ID
- 2025-0245
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabSingle infusion tocilizumab, 8 mg/kg, diluted in 100 mL of normal saline | Biological | Tocilizumab |
| Normal Saline (0.9% NaCl)Placebo, same volume as intervention | Drug | Placebo |
Primary outcome
Reduction in depressive symptoms (HDRS)
Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
≥50% reduction in score
11 secondary outcomes
Cognitive performance (Montreal Cognitive Test)
Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
Quality of life (EUROHISQOL8)
Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
BDNF levels
Time frame: Baseline and third follow-up post-intervention (28th day)
ECT indication after invervention
Time frame: Follow-ups (day 7, day 14, day 28 and month 6)
General psychiatric symptoms improvement (BPRS)
Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
Clinical global improvement (CGI)
Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
CRP levels
Time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)
IL-6 levels
Time frame: Baseline (for healthy controls) and baseline and follow-ups for intervention arm(day 7, day 14, day 28 and month 6)
Psychiatric hospitalization rate in 6 months
Time frame: 6 months follow-up
Suicidal ideation (MINI)
Time frame: Elegibility and follow-ups (day 7, day 14, day 28 and month 6)
Quality of life (WHOQOL-BREF)
Time frame: Baseline, follow-ups (day 7, day 14, day 28 and month 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 42285573Portal PHG, Peixoto GN, de Matos MR, da Silva LCN, Alexandrino GB, Dutra PHG, Carniel BP, da Rocha NS. Add-on tocilizumab versus placebo for resistant major depression in psychiatric outpatients with low-grade inflammation in a tertiary public hospital in Southern Brazil: randomised triple-blind clinical trial protocol. BMJ Open. 2026 Jun 12;16(6):e111421. doi: 10.1136/bmjopen-2025-111421.
- Individual participant dataSharing planned: No
Related trials for Treatment-Resistant Major Depressive Disorder
RecruitingPhase 3
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
Major Depression
Not yet recruiting
Effect of Neurofeedback and TMS
Depression - Major Depressive Disorder
RecruitingObservational study
Sensation Seeking and TMS Response in TRD
MDD, Severe Depression
Recruiting
Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression
Late Life Depression (LLD), Depression - Major Depressive Disorder
Recruiting
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
Major Depressive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neusa Sica da Rocha, PhD study director
Federal University of Rio Grande do Sul (UFRGS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab and Normal Saline (0.9% NaCl) in people with Treatment-Resistant Major Depressive Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neusa Sica da Rocha, PhD (55(51) 3359-8000, nrocha@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in depressive symptoms (HDRS) (time frame: Baseline and follow-ups (day 7, day 14, day 28 and month 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07052058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.