Actively Recruiting
Neutralizing Interleukin (IL)-6
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-04-29
60
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The proposed study aims to establish the feasibility and safety of subcutaneous tocilizumab, a monoclonal antibody (mAb) against interleukin (IL)-6 receptor, in adults with Major Depressive Disorder (MDD) and evidence of peripheral immune activation. IL-6 is a pro-inflammatory cytokine implicated in the pathophysiology of depression. The investigators hypothesize that neutralizing peripheral immune signaling via IL-6 receptor blockade with tocilizumab will improve neural and behavioral measures of reward processing. This is an open-label, proof-of concept, trial in which up to N=20 adults with MDD meeting a specific immune enrichment criterion will receive open-label tocilizumab over 8 weeks. A healthy control (HC) group (N=20) will undergo baseline neuroimaging and blood-based biomarker assessment without receiving the study drug to aid interpretation of findings. Blood-based immune markers and brain MRI scans (including task-based reward activation and resting-state functional connectivity) will be assessed at baseline for all participants and again post treatment for the MDD group.
CONDITIONS
Official Title
Neutralizing Interleukin (IL)-6
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 70 years
- Any gender
- Written informed consent
- Ability to comply with study requirements
- For MDD participants: DSM-5 diagnosis of MDD in a current Major Depressive Episode
- Elevated monocyte count ≥ 500 cells/µL at screening
- If on antidepressants, stable dose for at least 4 weeks prior to treatment
- SHAPS score of 20 or higher
- For females of childbearing potential, agreement to use medically accepted contraception or abstinence until 6 months after last dose
- For heterosexually active males with partners of childbearing potential, agreement to barrier contraception during treatment and for 6 months after last dose; female partners to use effective contraception starting one cycle prior to treatment until 6 months after last dose
- Meet all MRI safety criteria
- For healthy volunteers: no current or past DSM-5 psychiatric disorder
- Healthy volunteers must meet MRI safety criteria
You will not qualify if you...
- Primary psychiatric diagnosis other than MDD except comorbid anxiety disorders or PTSD
- History of schizophrenia, schizoaffective disorder, psychotic disorders, psychotic features of MDD, or bipolar disorder I or II
- Major neurocognitive disorder
- Moderate or severe substance use disorder within past 6 months (excluding nicotine)
- Positive urine toxicology for illicit substances at screening
- Serious or imminent risk of self-harm or violence including suicide attempt within 2 years or high suicide ideation score within past month
- Contraindications to MRI such as claustrophobia, metallic implants, pacemakers, or inability to tolerate MRI
- Clinically significant abnormalities on physical exam or labs
- Unstable or significant medical illness including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, neurologic, immunologic, or hematologic conditions
- Active or untreated infections including active or latent tuberculosis, HIV, hepatitis B or C
- Current or recent use of biologic or immunosuppressive therapies (NSAIDs allowed as needed)
- Known allergy to tocilizumab or its components
- Receipt of live or live-attenuated vaccine within 30 days prior to first dose or planned during study
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during study and for 6 months after last dose
- Any condition deemed by the investigator to compromise safety or data integrity
- For healthy volunteers: current or unstable medical illness, use of biologics or immunosuppressants, positive urine toxicology, pregnancy at baseline
AI-Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
A
Alexia Lizzano
CONTACT
M
Mackenzie Hargrove
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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