JAK Signaling in Depression and Cognition in Male Football Players
Emory University
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 10 years of organized football. This will be evaluated using a medication called baricitinib that blocks one aspect of inflammation.
Description
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 football. This will be assessed using a medication called baricitinib that blocks one aspect of inflammation. This study will enroll depressed adult male football players enriched for high inflammation \[blood levels of C-reactive protein (CRP)\], anhedonia, and cognitive dysfunction. Qualifying participants will be asked to take the study medication once daily by mouth for 8 weeks and undergo MRI scans, provide blood and…
Eligibility
- Age range
- 40–55 years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: * 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., m…
Interventions
- DrugBaricitinib
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.
Locations (3)
- Emory Clinic, Emory University HospitalAtlanta, Georgia
- Emory School Of MedicineAtlanta, Georgia
- Emory UniversityAtlanta, Georgia