NCT07608796 · Emory University
JAK Signaling in Depression and Cognition in Male Football Players
(JAK DC in Play)
What this study is about
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.
View original scientific 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 11 years of organized tackle football. This will be evaluated using a medication called baricitinib, which blocks one aspect of inflammation.
Interventions
DRUG
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 measures
Monetary Incentive Delay (MID) Task functional magnetic resonance imaging (fMRI)
Time frame: Baseline and weeks 2 and 8 post-intervention
Resting-state and task-based MID Task functional magnetic resonance imaging (fMRI). The MID Task is a specialized behavioral paradigm used during functional magnetic resonance imaging (fMRI). It isolates and measures the neural mechanisms of reward processing, specifically motivational salience, anticipation, and outcome feedback. fMRI blood oxygen level-dependent (BOLD) for resting and task-based functional connectivity: A multi-echo (ME) ep2 BOLD sequence will be optimized to provide a high signal-to-noise ratio in regions of interest that is maintained during minor incidences of head motion. Resting ME BOLD will be acquired over \~10 min, and task fMRI will involve two \~10 min scans. For resting bold, a single acquisition of phase-encoding in the opposite polarity (anterior-posterior) for distortion correction over \~30 seconds.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- willing and able to give written informed consent
- 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
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2026 · Source of record for eligibility and locations