Inflammation and Depression in People With HIV

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05849038
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Patients will receive baricitinib at a dose of 2 mg oral daily.
  • Placebo — OTHER
    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

The purpose of this 10-week, double-blind, placebo-controlled study is to determine whether inflammation impacts reward and motor neural circuitry to contribute to depressive symptoms like anhedonia and psychomotor slowing in people with Human Immunodeficiency Virus (HIV) and depression. Sixty male and female patients with HIV who have depression, anhedonia and high inflammation and are stable on effective treatment for their HIV will be randomized to receive either the anti-inflammatory drug baricitinib or a placebo for 10 weeks. Participants will complete lab tests, medical and psychiatric assessments, neurocognitive testing, functional MRI (fMRI) scans, and optional spinal taps as part of the study.

Key Dates

Start date
Dec 11, 2023
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib
    Participants will be randomized to receive 10 weeks of treatment with baricitinib.
  • Placebo Comparator: Placebo
    Participants will be randomized to receive 10 weeks of treatment with placebo.

Primary Outcome Measure

Change in corticostriatal functional connectivity (FC) in reward circuit [ Time Frame: Baseline visit, week 2, and week 10 after study medication ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Andrew H Miller, MD
[email protected]
(404) 727-8260
Grady Memorial HospitalAtlantaGeorgia30303
Vincent C Marconi, MD
[email protected]
404-616-0673

Find similar trials in Atlanta, GA

By condition
DepressionHIV
By specialty
PsychiatryMental healthBehavioral healthInfectious disease
By research site
Emory University Hospital· Atlanta, GAGrady Memorial Hospital· Atlanta, GA

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