JAK Signaling in Depression and Cognition in Male Football Players
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Baricitinib (Drug)
结局指标
主要结局
未指定
次要结局
- Inflammatory cytokines (IL-1, IL-6, TNF)(Baseline and weeks 2 and 8 post-intervention)
- High-sensitivity (hs) CRP(Baseline and weeks 2 and 8 post-intervention)
研究者
Andrew H Miller
Professor of Medicine
Emory University