Actively Recruiting
Inflammation and Depression in People With HIV
Led by Emory University · Updated on 2025-05-25
60
Participants Needed
2
Research Sites
203 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Inflammation and Depression in People With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV infection with continuous antiretroviral therapy and plasma HIV RNA <200 copies/ml for at least 12 months
- Current CD4+ count >350 cells/microliter for at least 12 months
- Diagnosis of major depression or bipolar depressed type by DSM-V and SCID-V
- Score of 10 or higher on the 9-item Patient Health Questionnaire (PHQ-9)
- Off antidepressant or psychotropic therapy for at least 4 weeks (8 weeks for fluoxetine) or on stable regimen for 4 weeks prior to baseline
- Significant anhedonia with a score of 2 or higher on item #1 of the PHQ-9
- C-reactive protein (CRP) level ≥ 2 mg/L
- Women of reproductive age must have negative pregnancy test and agree to contraception
You will not qualify if you...
- Age below 18 years or above 65 years
- Pregnancy or breastfeeding
- Significant blood abnormalities (ANC <1500, hemoglobin <10, platelets <100,000)
- History of progressive multifocal leukoencephalopathy
- Untreated latent tuberculosis infection
- Use of immunosuppressive medications within past 6 months, including oral corticosteroids, biologics, cytotoxic agents, B cell depleting therapies, or JAK inhibitors
- History of deep vein thrombosis
- Cardiovascular disease including coronary artery disease, heart failure with low ejection fraction, or stroke
- Blood cancers such as lymphoma or leukemia
- Major surgery within 8 weeks before screening or planned during study
- Current or recent serious infections or symptomatic herpes infections
- Positive hepatitis B or C infection tests
- Liver cirrhosis
- Abnormal liver function tests exceeding specified limits
- Chronic kidney disease with low estimated filtration rate
- History of psychotic disorders or recent substance abuse
- Positive urine drug screen for illicit drugs (excluding marijuana)
- Active suicidal plan with high depression scale score
- Active eating disorder or antisocial personality disorder
- History of dementia
- Recent use of NSAIDs, glucocorticoids, or minocycline
- Contraindications for MRI
- Failure of multiple antidepressant trials
- Severe obesity (BMI >42) or inability to fit in MRI scanner
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Actively Recruiting
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
J
Jennifer Felger, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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