Inflammation and Depression in People With HIV

This 10-week study is looking at how inflammation might affect depression, specifically anhedonia (inability to feel pleasure) and slow movements, in people with HIV. We are testing an anti-inflammatory drug called baricitinib against a placebo (a sugar pill with no medicine). We want to see if baricitinib can improve these symptoms by changing how the brain's reward system works. You might be able to join if you are 18-65 years old, have HIV that is well-controlled with medication, and also experience depression and high inflammation. The study aims to enroll 60 participants. We will know if the study is successful by observing changes in your brain's reward circuit activity after taking the study medication.

Study design: This is a 10-week, double-blind (neither you nor your doctor will know if you're getting the drug or placebo), placebo-controlled study involving 60 participants.
What's involved: You would have lab tests, medical and psychiatric check-ups, brain function tests, fMRI scans (brain imaging), and optional spinal taps. These assessments will happen at the start, week 2, and week 10 after starting the study medication.
Compensation: Not stated in the trial record.
Follow-up: Your brain's reward circuit activity will be measured at week 10 after starting the study medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Inflammation and Depression in People With HIV

Recruiting

PHASE2Ages 18–65InterventionalTreatment

Emory University

~60 participants

Updated 2026-05-28 on ClinicalTrials.gov

What's tested:BaricitinibPlacebo

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in corticostriatal functional connectivity (FC) in reward circuit

Measured over Baseline visit, week 2, and week 10 after study medication

Conditions

HIV

Depression

Anhedonia

Where it's being run

2 sites across 1 states

Georgia2

Study leadership

Andrew H Miller, MD · PRINCIPAL_INVESTIGATOR · Emory University
Jennifer Felger, PhD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Jennifer Felger, PhD

[email protected]

404-727-3987

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

Exclusion

\< 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:

History of deep venous thrombosis

Cardiovascular disease:

Hematologic malignancies including lymphoma and leukemia

Major surgery within 8 weeks prior to screening or will require major surgery during the study

Current or recent (\<4 weeks prior to randomization) clinically serious viral (including coronavirus disease 2019 (COVID-19)), bacterial, fungal, or parasitic infection or any other active or recent infection

Symptomatic herpes simplex at the time of randomization

Symptomatic herpes zoster infection within 12 weeks prior to randomization

History of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement)

Positive test for hepatitis B virus (HBV) defined as:

Hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid \[RNA\]-positive)

Cirrhosis of the liver from any cause

Any of the following specific abnormalities on screening laboratory tests:

Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m\^2

History of any (non-mood-related) psychotic disorder; active psychotic symptoms of any type; substance abuse/dependence within 6 months of study entry, as determined by severe combined immunodeficiency (SCID)

A positive urine drug screen for illicit drugs at any time during the study excluding marijuana

An active suicidal plan as determined by a score \>3 on item #3 on the Hamilton Rating Scale for Depression (HAM-D)

An active eating disorder or antisocial personality disorder

History of dementia

Chronic use of glucocorticoid containing medications or minocycline within 2 weeks of baseline or at any time during the study

Any contraindication for MRI scanning

Failure of more than 2 antidepressant trials (at least 6 weeks at recommended dose) in the current episode or 5 antidepressant trials lifetime

BMI \>42 (to exclude severe obesity) or at the investigator's discretion based on the patient's ability to fit in the MRI scanner

What this trial measures

Change in corticostriatal functional connectivity (FC) in reward circuitBaseline visit, week 2, and week 10 after study medication
Patients will undergo resting-state and task-based functional magnetic resonance imaging (fMRI) to calculate functional connectivity (FC) between the ventral striatum (VS) and ventromedial prefrontal cortex (vmPFC). FC is measured as continuous Z scores reflecting the correlation of activity between the brain regions. Higher FC Z scores reflect stronger connectivity.

Trialytics