JAK Signaling in Depression and Cognition in Male Football Players

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07608796
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cognitive Symptom
  • Depressive Symptoms

Eligibility Criteria

Sex
MALE
Age
40 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Baricitinib — DRUG
    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.

Study Details

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 Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

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

Locations (3)

FacilityCityStateZIPSite coordinators
Emory Clinic, Emory University HospitalAtlantaGeorgia30322-
Emory School Of MedicineAtlantaGeorgia30322-
Emory UniversityAtlantaGeorgia30329-

Find similar trials in Atlanta, GA

By research site
Emory Clinic, Emory University Hospital· Atlanta, GAEmory School Of Medicine· Atlanta, GAEmory University· Atlanta, GA

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