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NCT05849038 · ClinicalTrials.gov registry record · Phase 2
Inflammation and Depression in People With HIV
A Phase 2 study of Depression and HIV, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT05849038: Recruiting Phase 2 study of Depression and HIV, sponsored by Emory University.
NCT05849038 is a Phase 2 study of Depression and HIV that is actively recruiting participants, run by Emory University. The registered enrollment target is 60 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05849038, a Phase 2 study of Depression and HIV, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Baricitinib
Study Locations (2)
Georgia
- Grady Memorial Hospital - Atlanta
- Emory University Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-12-11 |
| Est. Completion | 2027-11 |
| Phase | Phase 2 |
What NCT05849038 shows while recruiting
NCT05849038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05849038 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05849038 about?
NCT05849038 is a clinical study titled "Inflammation and Depression in People With HIV". 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 ...
What is the current status of trial NCT05849038?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-12-11. Estimated completion is 2027-11.
What conditions does trial NCT05849038 study?
This clinical trial studies the following conditions: Depression, HIV, Anhedonia.
What interventions are being tested in trial NCT05849038?
The interventions under investigation include: Placebo (OTHER), Baricitinib (DRUG).
Who is sponsoring clinical trial NCT05849038?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05849038 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05849038's enrollment target sits among peer trials
60 428th of 679 higher than 234 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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