JAK Signaling in Depression and Cognition in Male Football Players

Обзор

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.

Подробное описание

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 urine samples for safety or to measure biomarkers of inflammation, complete clinician-rated and self-report assessments of depressive and cognitive symptoms, and perform computer or paper-and-pencil tests of neurocognitive function. Blood and other biological samples may be stored for future research use, with the participant's consent.

Вмешательства

• Препарат 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

Первичные конечные точки

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

Вторичные конечные точки (10)

• Effort-Expenditure for Rewards Task (EEFRT) [Срок оценки: Baseline and weeks 2, 4 and 8 post-intervention]
• Finger Tapping Test (FTT) [Срок оценки: Baseline and weeks 2, 4 and 8 post-intervention]
• Trail-Making Test (TMT) [Срок оценки: Baseline and weeks 2, 4 and 8 after baricitinib started]
• Anhedonia Subscale of the Inventory of Depressive Symptoms-Self Reported (IDSSR) [Срок оценки: Baseline and weeks 2, 4, 6, and 8 post-intervention]
• Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2A) [Срок оценки: Baseline and weeks 2 and 8 post-intervention]
• Snaith-Hamilton Pleasure Scale-Clinician (SHAPS-C) [Срок оценки: Baseline and weeks 2, 4, 5, 6, and 8 after baricitinib started]
• Hamilton Depression (HAM-D) Rating Scale [Срок оценки: Baseline and weeks 2, 4, 5, 6, and 8 post-intervention]
• Columbia Suicide Severity Rating Scale (CSSR) [Срок оценки: Baseline and weeks 2, 4, 5, 6, and 8 post-intervention]
• Phosphorylated Signal Transducer and Activator of Transcription 3 (pSTAT3) [Срок оценки: Baseline and weeks 2 and 8 post-intervention]
• Plasma inflammatory biomarkers [Срок оценки: Baseline and weeks 2 and 8 post-intervention]

Критерии участия

Критерии включения

• 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., 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 3 центра

• Emory Clinic, Emory University Hospital — Atlanta
• Emory School Of Medicine — Atlanta
• Emory University — Atlanta

Идентификаторы

NCT: NCT07608796 · 2026P000577

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗