Icahn School of Medicine at Mount Sinai
This study aims primarily to test target engagement of dupilumab by assessing changes in peripheral immune markers following interleukin-4 receptor alpha (IL-4Rα) blockade in adults with major depressive disorder (MDD). Secondary aims include evaluating safety, tolerability, feasibility, and open-label effects on depressive symptoms, blood-based immune markers, blood-brain barrier (BBB) function, and functional brain reward circuitry.
The proposed study aims to test interleukin-4 receptor alpha (IL-4α) as a novel immune target for major depressive disorder (MDD). The study will also evaluate whether the effects of dupilumab on blood immune markers are associated with changes in brain reward circuitry and depressive symptoms, and thereby providing mechanistic insight into its potential antidepressant effects. Dysregulation of blood immune markers has been previously demonstrated in patients with MDD. Dupilumab binds to IL-4-alpha receptors (IL-4Rα), blocking IL-4 and IL-13 and, consequently, downstream Th2 and other immune s…
Inclusion Criteria for MDD participants: 1. Written informed consent (and assent when applicable) obtained from subject; 2. Ability for the subject to comply with the requirements of the study as determined by the PI; 3. Men and women, age 18-65 years; 4. Participants must meet DSM-5 criteria for Major Depressive Disorder \[MDD\]) in a current major depressive episode (MDE) as determined by a study psychiatrist and confirmed using the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV); 5. If patient is taking antidepressant medication, they must be on a stable dose for at le…
At baseline (visit 0), participants in the major depressive disorder (MDD) arm will receive a subcutaneous injection of 600 mg of dupilumab. At visits 1 through 7, MDD participants will receive a 300 mg injection of dupilumab.
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.