Inflammation and Depression in People With HIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEmory University
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
< 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
Trial design
Treatments tested in this trial
- Baricitinib
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Emory University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov