Janus Kinase (JAK) Signaling in Depression
Emory University
Summary
This study will test the hypothesis that Janus kinase (JAK) signaling is involved in major depression (MD) with high inflammation by determining whether its inhibition with baricitinib can improve functional connectivity in reward and motor circuits in association with improved motivation and motor function in MD patients enriched for high C-reactive protein (CRP) and anhedonia.
Description
Many people with depression also have high inflammation, which may be a cause of some of their depression symptoms. This study is being done to learn how inflammation affects the brain to cause symptoms of depression like anhedonia, low motivation and motor slowing. This will be tested using a medication called baricitinib that blocks one aspect of inflammation involving Janus kinase (JAK) signaling. The population to be included in this study are patients with depression and symptoms of anhedonia who have high inflammation as determined by a blood test. Patients must also be free of uncontrol…
Eligibility
- Age range
- 25–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. willing and able to give written informed consent; 2. men or women, 25-55 years of age; 3. a primary diagnosis of DSM-V major depression, current, or Bipolar, depressed type as diagnosed by the SCID-V; 4. score of \>14 on the PHQ-9 from screening and HAM-D score ≥18 for study entry; 5. off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine), 6. CRP ≥3 mg/L, 7. PHQ-9 anhedonia score ≥2. Exclusion Criteria: 1. history or evidence (clinical a…
Interventions
- DrugBaricitinib
This small molecule, orally bioavailable agent is an immunosuppressant (a medicine that reduces the activity of the immune system). It works by blocking the action of enzymes known as Janus kinases (JAK). These enzymes play an important role in the processes of inflammation. Patients will receive a dose of 2 mg oral daily.
- DrugPlacebo
A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 1 placebo tablet matching the baricitinib tablet.
Location
- Emory UniversityAtlanta, Georgia