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JAK Signaling in Depression and Cognition in Male Football Players

Not Yet RecruitingPhase 2

Sponsor: Emory University

Conditions: Depressive Symptoms, Cognitive Symptom

Interventions: Baricitinib

Countries: United States

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 11 years of organized tackle football. This will be evaluated using a medication called baricitinib, which blocks one aspect of inflammation.

Eligibility overview

Sex: MALE

Age: 30 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (3)

Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States