Baricitinib for Depression in People With HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the anti-inflammatory drug baricitinib can help people with HIV and depression by reducing inflammation. The study focuses on patients who have high inflammation and are already on effective HIV treatment. Researchers want to see if lowering inflammation can improve brain functions related to pleasure and movement, potentially easing depressive symptoms.
Will I have to stop taking my current medications?
The trial requires that you either stop taking antidepressants or other psychotropic medications (like mood stabilizers or antipsychotics) for at least 4 weeks before starting, or be on a stable dose for at least 4 weeks. If you're taking fluoxetine, you need to stop it for 8 weeks before starting the trial.
How does the drug Baricitinib differ from other treatments for depression in people with HIV?
Baricitinib is unique because it is primarily used for conditions like rheumatoid arthritis and works by inhibiting specific enzymes (Janus kinases) involved in inflammation, which might offer a novel approach to treating depression in people with HIV by potentially addressing inflammation-related pathways that contribute to depression.12345
What data supports the effectiveness of the drug Baricitinib for depression in people with HIV?
Antidepressant medication has been shown to be effective in treating depression among HIV-positive individuals, with a significant pooled effect size in studies. However, the effectiveness of Baricitinib specifically for depression in this population is not directly addressed in the available research.12367
Who Is on the Research Team?
Andrew H Miller, MD
Principal Investigator
Emory University
Jennifer Felger, PhD
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the anti-inflammatory drug baricitinib or a placebo for 10 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Baricitinib
- Placebo
Baricitinib is already approved in United States, European Union for the following indications:
- Rheumatoid arthritis
- Severe alopecia areata
- COVID-19
- Rheumatoid arthritis
- Severe alopecia areata
- COVID-19
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator