Neutralizing Interleukin (IL)-6 (NCT07493317)
Neutralizing Interleukin (IL)-6 Signaling to Reverse Immune Related Anhedonia in Patients With Major Depressive Disorder
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Icahn School of Medicine at Mount Sinai — New York, New York
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Icahn School of Medicine at Mount Sinai — New York, New York
📞 Contact the Study Coordinator
Phone: (332) 243-7059
Email: alexia.lizzano@mssm.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Major Depressive Disorder
- Fisher Wallace Neurostimulation & Depression Study — New York, New York
- Study to Assess the Safety and Effectiveness of NMRA-335140-501 — Huntsville, Alabama
- Effects of Intravenous (IV) Citalopram Hydrochloride During Transcranial Magnetic Stimulation in Major Depressive Disorder (MDD) — Los Angeles, California
- Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin — Toronto, Ontario
- Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder — West Haven, Connecticut
- Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans — West Haven, Connecticut
Explore by condition: All Major Depressive Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.