JAK Signaling in Depression and Cognition in Male Football Players
Starting soon · Phase 2
Conditions studied: Depressive Symptoms, Cognitive Symptom
In brief
This study is being done to learn more about the role of inflammation in depressive and cognitive symptoms in patients with depression who have played at least 10 years of organized football. This will be evaluated using a medication called baricitinib that blocks one aspect of inflammation.
Key facts
- Study ID
- NCT07608796
- Run by
- Emory University
- People needed
- 30
- Starts
- 2026-06-01
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-05-27
Who can join
Age: 40 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- willing and able to give written informed consent
- males
- >10 years of playing football (at least 1 year in the NFL)
- 40-55 years of age
- Current Diagnostic and Statistical Manual (DSM)-V major depression or Bipolar, depressed type; or DSM-V major depression or Bipolar, depressed type in partial remission as diagnosed by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID)-V
- score of >10 on the PHQ-9 from screening and HAM-D score ≥16 for study entry
- off all antidepressant or other psychotropic therapy (e.g., mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks before baseline visit (8 weeks for fluoxetine) or on a stable psychotropic regimen for at least 4 weeks (and no planned changes)
- CRP ≥3 mg/L
- PHQ-9 anhedonia (item #1) and cognitive (item #7) scores ≥2
You may not qualify if…
- current or history of past autoimmune disorder
- history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection
- history of any type of cancer requiring treatment with more than minor surgery
- unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination, EKG, and laboratory testing)
- significant hematological abnormalities at screening (ANC < 1500, Hgb<10, platelet< 100,000)
- history of progressive multifocal leukoencephalopathy
- history of deep venous thrombosis
- history of cardiovascular disease (coronary artery disease, congestive heart failure, stroke - controlled hypertension is OK)
- major surgery within 6 months before screening, or will require major surgery during the study
- current or recent (<4 weeks before study start) viral (including COVID-19), bacterial, fungal, or parasitic infection, or any other active or recent infection
- symptomatic herpes zoster infection at or within 12 weeks of study start
- history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement)
- cirrhosis of the liver from any cause
- Additional exclusion criteria apply
Where it is running
- Emory Clinic, Emory University Hospital — Atlanta, Georgia, United States
- Emory School Of Medicine — Atlanta, Georgia, United States
- Emory University — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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