RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Dupilumab Injection for Major Depressive Disorder

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 (major depression). 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.

Official registry: https://clinicaltrials.gov/study/NCT07908563 · Icahn School of Medicine at Mount Sinai · enrollment listed as 34

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Dupilumab Injection. The registry lists allocation as randomized. 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 (major depression).

They plan to enroll about 34 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Target Validation of Interleukin-4 Receptor Alpha for Major Depressive Disorder

Interventions: Dupilumab Injection

Primary outcome (registry wording): Interleukin-4 receptor alpha (IL-4α)

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
for major depression participants:
Ability for the subject to comply with the requirements of the study as determined by the PI;
Men and women, age 18-65 years;
Participants must meet DSM-5 criteria for Major Depressive Disorder \[major depression\]) 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);
If patient is taking antidepressant medication, they must be on a stable dose for at least 4 weeks prior to baseline (6 weeks for fluoxetine);
Quick Inventory of Depressive Symptoms - Clinician Administered (QIDS-C) score ≥ 14;

Who the registry excludes

for major depression Participants:
A primary psychiatric diagnosis other than major depression as defined by DSM-5; \[comorbid anxiety disorders (including agoraphobia, generalized anxiety disorder, social anxiety disorder and panic disorder) and posttraumatic stress disorder (PTSD) are allowed\];
Has a history of schizophrenia or other psychotic disorder, major depressive disorder with psychotic features, or bipolar I or II disorder;
Diagnosis of a major neurocognitive disorder;
Meets criteria for a moderate or severe substance use disorder within the past 6 months, with the exception of nicotine use disorder;
Any contraindication to MRI including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, or inability to lie still for 1 hour or more;
Positive urine toxicology screen for illicit drugs (other than cannabis) at the time of screening;

Public study contact (from the registry)

Mackenzie B Hargrove, MPH

332-243-7052

mackenzie.brown@mssm.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

The Dennis S. Charney, MD, Depression and Anxiety Discovery Center — New York, New York (recruiting)

Related recruiting trials in this snapshot

RecruitingPhase 2Bethesda, Maryland

Phase 2: testing Fluoxetine for Anxiety Disorders

Study Description: This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG).

NCT00018057 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)

RecruitingPhase 2Bethesda, Maryland

Phase 2: testing Ketamine Hydrochloride for Healthy Volunteers

Background: There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies.

NCT02543983 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)

RecruitingPhase 1 / Phase 2Boston, Massachusetts

Phase 1 / Phase 2: testing [F-18]PBR06 for Multiple Sclerosis

The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.

NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital

FAQ about this NCT record

Is NCT07908563 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07908563?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07908563?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary