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Anti-inflammatory
Baricitinib for Depression in People With HIV
Verified Trial
Phase 2
Recruiting
Led By Andrew H Miller, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are you currently depressed?
Over the past two weeks, have you experienced little interest or pleasure in doing things (including low motivation to engage in activities, or feeling like “everything is an effort”)?
Must not have
Have you ever been diagnosed or treated for an autoimmune disorder or cancer (excluding skin cancer)?
Timeline
Screening 2 days
Treatment 10 weeks
Follow Up 2 weeks
Awards & highlights
Study Summary
This trial will test if inflammation can cause depression in HIV patients. 60 HIV+ depressed patients will get drug or placebo for 10 wks. They'll do tests, scans, & optional spinal taps over 3.5 months.
Who is the study for?
This trial is for men and women with HIV who are stable on treatment, have depression with significant anhedonia (lack of pleasure including low motivation or feeling like everything is an effort), and high inflammation. They must not be pregnant or breastfeeding, should agree to use contraception, have a CD4+ count over 350, no major health issues like heart failure or untreated infections, and not be on certain medications.Check my eligibility
What is being tested?
The study tests if the anti-inflammatory drug baricitinib affects depressive symptoms in people with HIV compared to a placebo. Participants will undergo medical assessments, neurocognitive testing, brain scans (fMRI), and optional spinal taps over approximately 3.5 months.See study design
What are the potential side effects?
Baricitinib may cause side effects such as infection risk increase due to immune system suppression, blood clotting problems which could lead to deep vein thrombosis or stroke-like conditions, liver issues indicated by abnormal lab results, potential allergic reactions among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 2 days2 visits
Treatment ~ 10 weeks6 visits
Follow Up ~ 2 weeks1 visit
Screening ~ 2 days
Treatment ~ 10 weeks
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in corticostriatal functional connectivity (FC) in reward circuit
Secondary outcome measures
Change in Effort Expenditure for Reward Task (EEfRT) Score
Change in Finger Tapping Task (FTT) Mean Number of Taps
Change in Finger Tapping Task (FTT) Total Number of Taps
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BaricitinibExperimental Treatment1 Intervention
Participants will be randomized to receive 10 weeks of treatment with baricitinib.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive 10 weeks of treatment with placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
2017
Completed Phase 3
~9510
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,597 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,649 Total Patients Enrolled
Andrew H Miller, MDPrincipal InvestigatorEmory University
4 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive, on ART, and my viral load has been under 200 for over a year.My CD4+ count has been over 350 for at least a year.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Baricitinib
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 10 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 2 Weeks after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA officially authorized Baricitinib for medical use?
"Based on our team's assessment at Power, Baricitinib has been assigned a safety rating of 2 on the scale from 1 to 3. This decision was made in light of ongoing Phase 2 trials which have generated initial safety data but are yet to produce evidence regarding efficacy."
Answered by AI
What is the current number of individuals enrolled in this research study?
"Affirmative. Details on clinicaltrials.gov reveal that this trial is presently enrolling participants. It was first listed on December 11, 2023, with the most recent update made on February 8, 2024. The aim is to enroll a total of 60 individuals at one specific site."
Answered by AI
Is the study open to participants younger than 85 years old?
"The trial is enrolling individuals above the age of 18 but below 65 years old."
Answered by AI
Are individuals currently able to apply and participate in this ongoing research study?
"As confirmed by clinicaltrials.gov, this investigation is currently enrolling volunteers. The trial's initial posting was on December 11th, 2023, with the most recent update dated February 8th, 2024."
Answered by AI
Who else is applying?
What site did they apply to?
Emory University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I’m interested in new treatments and modalities.
PatientReceived 1 prior treatment
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