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34 Participants NeededMy employer runs this trial

Dupilumab for Depression

MB
AL
Overseen ByAlexia Lizzano, BS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JW

James W Murrough, MD, PhD

Principal Investigator

Icahn School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with major depressive disorder (MDD). Specific inclusion and exclusion criteria are not listed, but generally participants should be adults with MDD who meet safety requirements set by the study team.

Inclusion Criteria

Healthy control participants: Written informed consent obtained from subject
MDD participants: Written informed consent (and assent when applicable) obtained from subject
Healthy control participants: Ability for the subject to comply with the requirements of the study as determined by the PI
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Exclusion Criteria

I am currently pregnant.
I have had cancer (not counting non-melanoma skin cancer) in the past 5 years.
I do not have any serious or unstable medical illnesses that could affect my participation.
See 16 more

What Are the Treatments Tested in This Trial?

Interventions

  • Dupilumab

Trial Overview

The study is testing dupilumab injections to see how they affect immune markers in people with depression. Researchers will also look at safety, side effects, and changes in mood or brain function. All participants receive dupilumab; there is no placebo group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Major Depressive DisorderExperimental Treatment1 Intervention
Group II: Healthy ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Wellcome Trust

Collaborator

Trials
236
Recruited
15,770,000+

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