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Recruiting Phase 2 NCT07003997

JAK Signaling in Depression

Trial Parameters

Condition Major Depressive Disorder
Sponsor Emory University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 100
Sex ALL
Min Age 25 Years
Max Age 55 Years
Start Date 2025-09-03
Completion 2030-02
Interventions
BaricitinibPlacebo

Brief 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 Criteria

Inclusion Criteria: 1. willing and able to give written informed consent; 2. men or women, 25-55 years of age; 3. a primary diagnosis of DSM-V major depression, current, or Bipolar, depressed type as diagnosed by the SCID-V; 4. score of \>14 on the PHQ-9 from screening and HAM-D score ≥18 for study entry; 5. off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine), 6. CRP ≥3 mg/L, 7. PHQ-9 anhedonia score ≥2. Exclusion Criteria: 1. history or evidence (clinical and laboratory) of an autoimmune disorder 2. history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection; 3. history of any type of cancer requiring treatment with more than minor surgery; 4. unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination, EKG and laboratory test

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