drugset / Trial / NCT05849038

Inflammation and Depression in People With HIV

NCT05849038

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-12-11
Primary completion
2027-11
Completion
2027-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Baricitinib Small molecule 2 mg Oral