RecruitingPhase 2NCT07003997

JAK Signaling in Depression

Janus Kinase (JAK) Signaling in Depression


Sponsor

Emory University

Enrollment

100 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will test the hypothesis that Janus kinase (JAK) signaling is involved in major depression (MD) with high inflammation by determining whether its inhibition with baricitinib can improve functional connectivity in reward and motor circuits in association with improved motivation and motor function in MD patients enriched for high C-reactive protein (CRP) and anhedonia.


Eligibility

Min Age: 25 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a JAK inhibitor (a type of anti-inflammatory drug) can help treat depression that is linked to inflammation in the body. Researchers believe that high levels of inflammation may contribute to depression that doesn't respond well to standard antidepressants. **You may be eligible if...** - You are between 25 and 55 years old - You have a current diagnosis of major depression or bipolar disorder (depressed phase) - Your depression score is above a moderate threshold (PHQ-9 > 14 at screening; HAM-D ≥ 18) - You have elevated inflammation markers (CRP ≥ 3 mg/L) - You have been off all antidepressants or psychiatric medications for at least 4 weeks (8 weeks for fluoxetine) - You have significant loss of interest or pleasure (anhedonia) **You may NOT be eligible if...** - You have an autoimmune disease, hepatitis B or C, or HIV - You have a history of cancer (other than minor surgery) - You have heart disease, stroke, blood clots, or other serious cardiovascular conditions - You have had major surgery recently or are scheduled for one - You have a history of a rare brain infection (progressive multifocal leukoencephalopathy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBaricitinib

This small molecule, orally bioavailable agent is an immunosuppressant (a medicine that reduces the activity of the immune system). It works by blocking the action of enzymes known as Janus kinases (JAK). These enzymes play an important role in the processes of inflammation. Patients will receive a dose of 2 mg oral daily.

DRUGPlacebo

A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 1 placebo tablet matching the baricitinib tablet.


Locations(1)

Emory University

Atlanta, Georgia, United States

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NCT07003997


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