Neutralizing Interleukin (IL)-6

Recruiting Phase 2 Interventional Study
Major Depressive Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
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About This Trial
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 immun…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: For MDD participants: * 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 c…
Contacts

Alexia Lizzano

3322437059

alexia.lizzano@mssm.edu

CONTACT

Mackenzie Hargrove

3322437052

mackenzie.brown@mssm.edu

CONTACT