RightFit
RecruitingPhase 2

JAK Signaling in Depression and Cognition in Male Football Players

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 55 Years
Sex
Male only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks
  • Procedures mentioned: Urine samples, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests baricitinib, a medicine that blocks part of inflammation, or swelling inside the body. It looks at how inflammation affects depression and problems with thinking in men ages 30–55 who have played organized tackle football for at least 11 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can and will give written consent to join.
  • Are male, age 30–55, and have played tackle football for at least 11 years.
  • Have major depression or bipolar disorder with depression, including symptoms that have partly improved, confirmed by a study interview.
  • Score above 10 on the PHQ-9 depression survey at screening and at least 16 on the HAM-D depression scale to enter.
  • Score at least 2 on both PHQ-9 questions about loss of interest or pleasure and trouble concentrating.
  • Have stopped all medicines for mental health for at least 4 weeks before the first study visit, or 8 weeks for fluoxetine; OR have taken the same treatment for at least 4 weeks with no changes planned.
  • Have a CRP level of at least 3 mg/L. CRP is a blood marker of inflammation.

Who can't join

  • Have or have had an autoimmune disease, where the body's defenses attack healthy tissue; hepatitis B or C; or HIV.
  • Have had cancer that needed more than minor surgery, or have cirrhosis, which is liver scarring.
  • Have an unstable heart, hormone, blood, liver, kidney, or nerve or brain disease; or certain low blood cell counts at screening.
  • Have had progressive multifocal leukoencephalopathy, a serious brain infection, or a blood clot in a deep vein.
  • Have had heart artery disease, heart failure, or a stroke. Controlled high blood pressure is allowed.
  • Had major surgery within 6 months before screening, or will need it during the study.
  • Have an infection now or had one less than 4 weeks before the study starts, including COVID-19.
  • Have shingles symptoms at or within 12 weeks of study start, or have ever had shingles that spread or caused complications, such as eye or brain problems. Other exclusion rules also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * willing and able to give written informed consent * males * 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

Study sites (3)

GA