Tocilizumab for Major Depressive Disorder with Immune Activation
This study is testing a drug called tocilizumab in adults with Major Depressive Disorder (MDD) who also show signs of immune system activation (specifically, an elevated monocyte count in their blood). Tocilizumab is a monoclonal antibody (a type of protein that targets specific cells or substances) that blocks a protein called IL-6, which is thought to play a role in depression. Researchers want to see if tocilizumab is safe and practical to use, and if it can improve how your brain processes rewards. You would receive tocilizumab injections over 8 weeks. The study aims to enroll up to 60 participants, but the current status is unclear.
- Study design
- This is an open-label, proof-of-concept study, meaning both you and the study team will know you are receiving tocilizumab. It aims to enroll up to 60 participants.
- What's involved
- If you join, you would receive tocilizumab injections under the skin at weeks 0, 2, 4, 6, and 8. You would also have brain scans (fMRI) and blood tests at the beginning and at week 10.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your brain activity during reward processing will be measured at week 10, two weeks after your last dose of tocilizumab.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07493317
Neutralizing Interleukin (IL)-6
Recruiting
PHASE2Ages 18–70InterventionalTreatmentIcahn School of Medicine at Mount SinaiInvestigator-initiated
~60 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:Tocilizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ventral stratal activation during reward processing (fMRI)
Measured over at week 0 and week 10
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- James Murrough · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Written informed consent;
Ability to comply with the requirements of the study as determined by the PI;
Ages 18-70 years;
Any gender;
DSM-5 diagnosis of MDD in a current Major Depressive Episode;
Immune enrichment criterion: elevated monocyte count ≥ 500 cells/μL at screening;
If patient is on antidepressant medication, they must be on a stable dose for ≥4 weeks prior to treatment;
SHAPS score ≥20
If female of childbearing potential, must agree to use of a medically accepted form of contraception, or else agree to abstinence until 6 months after the last dose of study drug;
Male patients, if heterosexually active with a partner who is female of childbearing potential, pregnant, or breastfeeding, must agree to barrier contraception for the treatment period and for at least 6 months after the last dose of the study drug. Female partners of male participants must use at least one form of highly effective contraception starting at least one cycle prior to male patient study drug initiation until 6 months after the last dose of study drug.
Meet all MRI safety criteria.
Written informed consent;
Ability to comply with the requirements of the study as determined by the PI;
Ages 18-70
Any gender;
No current or past DSM-5 psychiatric disorder;
Meet all MRI safety criteria.
Exclusion
A primary DSM-5 psychiatric diagnosis other than MDD, with the exception of comorbid anxiety disorders (including agoraphobia, generalized anxiety disorder, social anxiety disorder, panic disorder) and post-traumatic stress disorder, which are permitted.
History of schizophrenia, schizoaffective disorder, other psychotic disorder, MDD with psychotic features, or bipolar I or II disorder.
Diagnosis of a major neurocognitive disorder.
Moderate or severe substance use disorder within the past 6 months (excluding nicotine use disorder).
Positive urine toxicology screen for illicit substances at screening.
Serious or imminent risk of self-harm or violence, as determined by the PI, including:
Suicide attempt within the past 2 years, or
C-SSRS ideation score \>2 within the past month.
Any contraindication to MRI, including claustrophobia, retained metallic foreign bodies, magnetic implants or pacemakers, or inability to tolerate MRI procedures.
Clinically significant abnormalities on physical examination or laboratory testing.
Unstable or clinically significant medical illness, including but not limited to hepatic, renal, gastrointestinal, respiratory, cardiovascular (including ischemic heart disease), endocrine, neurologic (including history of severe head injury), immunologic, or hematologic conditions.
Evidence of active or untreated infection, including
Active tuberculosis (TB) or untreated latent TB
Positive QuantiFERON-TB Gold test at screening
Known HIV infection
Active Hepatitis B or Hepatitis C infection
Current or recent (within an appropriate washout period) use of biologic therapies or other immunosuppressive agents (PRN NSAIDs permitted).
Known hypersensitivity to tocilizumab or its excipients.
Receipt of a live or live-attenuated vaccine within 30 days prior to first dose, or planned receipt during the study period.
Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study and for 6 months after the last dose.
Any condition that, in the opinion of the PI, would compromise participant safety or data integrity.
Any current or unstable medical illness, including hepatic, renal, gastrointestinal, respiratory, cardiovascular (including ischemic heart disease), endocrine, neurologic (including history of severe head injury), immunologic, or hematologic disease.
Use of biologic therapies or immunosuppressive agents (PRN NSAIDs permitted).
Positive urine toxicology screen for illicit substances at screening.
Pregnancy at the time of baseline assessments (e.g., MRI).
What this trial measures
- Change in ventral stratal activation during reward processing (fMRI)at week 0 and week 10
Change in ventral stratal activation (brain response) during reward processing (fMRI)