Baricitinib for Depression and Cognition in Experienced Male Football Players

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial enrolling adult male tackle football players with major depression or bipolar depression in the depressed phase, enriched for higher inflammation. Participants will take baricitinib by mouth daily for 8 weeks and undergo MRI scans, blood and urine testing, and neurocognitive assessments. The study will evaluate changes in depressive symptoms and cognitive function, with biomarker analyses to explore inflammation. Safety monitoring and optional storage of biological samples for future research will be conducted with informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* willing and able to give written informed consent
* males
* playing tackle football for at least 11 years
* 30-55 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

Exclusion Criteria:

* 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's running

• Emory Clinic, Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Emory School Of Medicine
  Atlanta, Georgia, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Andrew H Miller, MD — Emory University
• Study coordinator: Andrew H Miller, MD
• Email: amill02@emory.edu
• Phone: 404-727-8260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.