Inflammation and Depression in People With HIV
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Emory University
You may qualify if…
- ✓ HIV infected on continuous antiretroviral therapy (ART) with plasma HIV RNA \<200 copies/ml for at least 12 months (on at least two previous clinic visits and confirmed at screening)
- ✓ Current cluster of differentiation 4 (CD4+) \> 350 cells/microliter for at least twelve months (on at least two previous clinic visits and confirmed at screening)
- ✓ A primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) major depression, current, or Bipolar, depressed type as diagnosed by the SCID-V
- ✓ Score of ≥10 on the 9-item Patient Health Questionnaire (PHQ-9)
- ✓ Off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks (8 weeks for fluoxetine) or on a stable psychotropic regimen for at least 4 weeks prior to baseline visit
- ✓ Significant anhedonia as reflected by a score ≥ 2 on item #1 of the PHQ-9
- ✓ CRP≥2mg/L
- ✓ Women of reproductive age will have a negative serum pregnancy test at study entry and both men and women must agree to adequate contraception while
You may not qualify if…
- ✕ \< 18 years of age or \> 65 years of age
- ✕ Pregnancy or breastfeeding
- ✕ Significant hematological abnormalities at screening (ANC \< 1500, Hgb\<10, platelet\< 100,000)
- ✕ History of progressive multifocal leukoencephalopathy
- ✕ Untreated latent tuberculosis infection (which will be screened for prior to entry)
- ✕ Having taken the following immunosuppressive medications within the past 6 months:
- ✕ 1. Oral corticosteroids
- ✕ 2. Biologic treatments such as etanercept, infliximab, certolizumab, adalimumab, golimumab, tocilizumab, abatacept, Ustekinumab, ixekizumab, secukinumab, or anakinra
Where it's recruiting
Atlanta
Source: ClinicalTrials.gov · NCT05849038 · last updated 2026-05-28