Actively Recruiting

Phase 2
Age: 25Years - 55Years
All Genders
NCT07003997

JAK Signaling in Depression

Led by Emory University · Updated on 2025-09-15

100

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

JAK Signaling in Depression

Who Can Participate

Age: 25Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to give written informed consent
  • Men or women aged 25 to 55 years
  • Primary diagnosis of DSM-V major depression, current, or bipolar depressed type by SCID-V
  • PHQ-9 score greater than 14 and HAM-D score 18 or higher at screening
  • Off all antidepressant or psychotropic therapy for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine)
  • C-reactive protein (CRP) level 3 mg/L or higher
  • PHQ-9 anhedonia score 2 or higher
Not Eligible

You will not qualify if you...

  • History or evidence of autoimmune disorder
  • History or evidence of hepatitis B, hepatitis C, or HIV infection
  • History of cancer requiring more than minor surgery
  • Unstable cardiovascular, endocrine, blood, liver, kidney, or neurological disease
  • Significant blood abnormalities (ANC < 1500, hemoglobin < 10, platelets < 100,000)
  • History of progressive multifocal leukoencephalopathy
  • History of deep venous thrombosis
  • History of cardiovascular disease (except controlled hypertension)
  • Major surgery within 8 weeks prior to screening or planned during the study
  • Current or recent (within 4 weeks) active infection including viral, bacterial, fungal, or parasitic
  • Symptomatic herpes zoster infection at or within 12 weeks of randomization
  • History of complicated herpes zoster
  • Liver cirrhosis
  • Abnormal liver tests exceeding specified limits
  • Chronic kidney disease with eGFR < 60 mL/min/1.73 m2
  • History of non-mood-related psychotic disorder or active psychotic symptoms
  • Substance abuse or dependence within 6 months prior to study entry
  • Active suicidal plan with HAM-D item #3 score over 3
  • Active eating disorder except binge eating disorder linked to mood
  • History of cognitive disorder or traumatic head injury with loss of consciousness
  • Pregnancy or lactation
  • Use of gender affirming hormone therapy
  • Chronic use of NSAIDs (except low-dose aspirin), immunosuppressives, glucocorticoids, or minocycline within 6 months or anti-inflammatory supplements within 2 weeks prior to baseline
  • Contraindication for MRI scanning
  • Failure of more than 2 antidepressant trials in current episode or 5 lifetime
  • Body mass index over 45 or unable to fit in MRI scanner

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

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Research Team

J

Jennifer Felger, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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