JAK Signaling in Depression
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Emory University
- Study ID
- NCT07003997
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 25 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- Baricitinib — DRUGThis 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.
- Placebo — DRUGA 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.
Study Details
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.
Key Dates
- Start date
- Sep 3, 2025
- Status verified
- Sep 2025
- Primary completion
- Feb 28, 2030
- Completion
- Feb 28, 2030
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Baricitinib ArmBaricitinib at dose of 2 mg will be dispensed to be taken orally, daily for 8 weeks.
- Placebo Comparator: Placebo ArmPlacebo will be dispensed to be taken orally, daily for 8 weeks.
Primary Outcome Measure
Change in corticostriatal FC in reward and motor circuits after 2 and 8 weeks of study medication [ Time Frame: Baseline, week 2 and 8 post-intervention ]
Central Contacts
- Jennifer Felger, PhD404-727-3987
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | Jennifer Felger, PhD |
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