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 — DRUG
    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.
  • Placebo — DRUG
    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.

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 Arm
    Baricitinib at dose of 2 mg will be dispensed to be taken orally, daily for 8 weeks.
  • Placebo Comparator: Placebo Arm
    Placebo 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

Locations (1)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Jennifer Felger, PhD

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