Recruiting
Phase 2

Baricitinib

Sponsor:

Emory University

Code:

NCT07608796

Conditions

Depressive Symptoms

Cognitive Symptom

Eligibility Criteria

Sex: Male

Age: 30 - 55

Healthy Volunteers: Accepted

Interventions

Baricitinib

Study Details

Brief summary:

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.

Conditions

Depressive Symptoms

Cognitive Symptom

Study ID

NCT07608796

Start date

Oct, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Baricitinib

Participants will receive 1 tablet/d of 2 mg baricitinib at baseline. For participants who do not exhibit a clinical response at 4 Weeks (a 50% reduction in HAM-D scores), the dose will be increased to 4 mg/day (2 tablets/d of baricitinib), as tolerated.

Interventions

Baricitinib

Baricitinib is an orally administered, selective inhibitor of Janus kinase (JAK) 1 and 2. It reduces cytokine-mediated signaling involved in inflammation and immune activation. Baricitinib is FDA-approved for rheumatoid arthritis (RA), atopic dermatitis, and alopecia areata. It has also been authorized for the treatment of COVID-19 in hospitalized patients. Baricitinib will be dispensed every other week at the Week 2, 4, and 6 study visits. Participants who do not exhibit a clinical response (50% reduction in HAM-D scores from baseline) at Week 4 will be increased to 4 mg/day of baricitinib (2 x 2 mg tablets). A virtual follow-up visit will be conducted at Week 1 to assess safety and tolerability in all patients, and at Week 5 in patients who increase the dose.

Primary outcome measure

  • Monetary Incentive Delay (MID) Task functional magnetic resonance imaging (fMRI) [ Time Frame: Baseline and weeks 2 and 8 post-intervention ]

Central Contacts and Locations

Central contacts

Andrew H Miller, MD

404-727-8260amill02@emory.edu

Locations

Emory Clinic, Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Emory School Of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Emory University

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Emory University

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • Football player
  • Inflammation
  • NFL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Emory University on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.