RecruitingPhase 2NCT05849038

Inflammation and Depression in People With HIV

The Role of Inflammation in Central Nervous System (CNS) Mechanisms of Anhedonia and Psychomotor Slowing in Depressed People With HIV

Sponsor

Emory University

Enrollment

60 participants

Start Date

Dec 11, 2023

Study Type

INTERVENTIONAL

Conditions

Depression Anhedonia HIV

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether elevated inflammation in the body — even when HIV is well controlled by medication — contributes to depression in people living with HIV. Researchers will test whether a targeted anti-inflammatory drug can improve mood in this group. **You may be eligible if...** - You are living with HIV and have been on antiretroviral therapy (ART) consistently - Your HIV viral load has been undetectable (less than 200 copies/mL) for at least 12 months - Your immune cell count (CD4+) is above 350 cells/microliter - You have symptoms of depression - Blood tests show elevated markers of inflammation **You may NOT be eligible if...** - Your HIV is not well controlled or you have recently changed medications - You have a recent history of heart attack, stroke, or major cardiovascular event - You have serious liver or kidney disease - You are pregnant or breastfeeding - You are currently using recreational drugs or drinking heavily Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBaricitinib

Patients will receive baricitinib at a dose of 2 mg oral daily.

OTHERPlacebo

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.