60 Participants Needed

Baricitinib for Depression in People With HIV

Recruiting at 2 trial locations
JF
Overseen ByJennifer Felger, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Emory University
Must be taking: Antiretroviral therapy
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

AH

Andrew H Miller, MD

Principal Investigator

Emory University

JF

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

You have been diagnosed with HIV
Have you been on stable antiretroviral therapy (ART) regimen for more than 1 year?
Have you been diagnosed with HIV?
See 3 more

Exclusion Criteria

Are you pregnant, actively trying to become pregnant, or are you breastfeeding?
Do you have any reason you cannot have an MRI scan (e.g. pacemaker)?
Have you ever been diagnosed or treated for an autoimmune disorder or cancer (excluding skin cancer)?
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the anti-inflammatory drug baricitinib or a placebo for 10 weeks

10 weeks
Baseline visit and week 10 visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Baricitinib
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
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.

Baricitinib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Olumiant for:
  • Rheumatoid arthritis
  • Severe alopecia areata
  • COVID-19
🇪🇺
Approved in European Union as Olumiant for:
  • Rheumatoid arthritis
  • Severe alopecia areata
  • COVID-19

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

Patients with HIV should be routinely screened for major depression, as accurate diagnosis is crucial to avoid harmful exposure to inappropriate psychotropic medications.
Antidepressants used to treat major depression in HIV-infected patients are similar to those used in the general population, and while no specific antidepressant is superior, patient adherence is key, influenced by the side effects of these medications.
Drug treatment of depression in HIV-positive patients : safety considerations.Pieper, AA., Treisman, GJ.[2022]
Antidepressant medications have been found to be effective in treating depression among HIV-positive individuals, with a pooled effect size of 0.57 based on a systematic review of 7 studies involving 494 subjects.
However, the studies showed significant variability in results, largely influenced by placebo responses, and highlighted a concerning lack of representation of women and minorities, suggesting that future research should focus on these underrepresented groups to improve generalizability.
Efficacy of antidepressant medication among HIV-positive individuals with depression: a systematic review and meta-analysis.Himelhoch, S., Medoff, DR.[2022]
In a study of 881 HIV-infected veterans, 46% exhibited significant depressive symptoms, but these symptoms did not correlate with illness severity or survival rates after adjusting for HIV symptoms.
HIV symptoms were found to be significantly associated with both the severity of illness and survival, indicating that healthcare providers should prioritize addressing HIV symptoms independently of any depressive symptoms present.
Clinical importance of HIV and depressive symptoms among veterans with HIV infection.Kilbourne, AM., Justice, AC., Rollman, BL., et al.[2019]

Citations

Drug treatment of depression in HIV-positive patients : safety considerations. [2022]
Efficacy of antidepressant medication among HIV-positive individuals with depression: a systematic review and meta-analysis. [2022]
Clinical importance of HIV and depressive symptoms among veterans with HIV infection. [2019]
Validating a shortened depression scale (10 item CES-D) among HIV-positive people in British Columbia, Canada. [2022]
The effect of antidepressant treatment on HIV and depression outcomes: results from a randomized trial. [2022]
Antidepressant treatment and health services utilization among HIV-infected medicaid patients diagnosed with depression. [2019]
Human immunodeficiency virus-associated depression: contributions of immuno-inflammatory, monoaminergic, neurodegenerative, and neurotrophic pathways. [2021]
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