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Could an arthritis drug lift depression in HIV patients?

NCT ID NCT05849038

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether inflammation in the brain causes symptoms like loss of interest and slow movement in depressed people with HIV. Sixty participants will receive either the anti-inflammatory drug baricitinib or a placebo for 10 weeks. Researchers will use brain scans and motivation tests to see if the drug improves these symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
baricitinib (Olumiant)
What this could lead to
If it works, this could point toward a new treatment for depression in people with HIV by targeting inflammation.
What could go wrong
This is a small, early-phase study with only 60 participants. The drug may not improve symptoms, and side effects like infection risk are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) * Off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks (8 weeks for fluoxetine) or on a stable psychotropic regimen for at least 4 weeks prior to baseline visit * Significant anhedonia as reflected by a score ≥ 2 on item #1 of the PHQ-9 * CRP≥2mg/L * Women of reproductive age will have a negative serum pregnancy test at study entry and both men and women must agree to adequate contraception while Exclusion Criteria: * \< 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 * Untreated latent tuberculosis infection (which will be screened for prior to entry) * Having taken the following immunosuppressive medications within the past 6 months: 1. Oral corticosteroids 2. Biologic treatments such as etanercept, infliximab, certolizumab, adalimumab, golimumab, tocilizumab, abatacept, Ustekinumab, ixekizumab, secukinumab, or anakinra 3. Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-interferon (IFN) therapy) 4. Rituximab, any other B cell depleting therapies, or intravenous immunoglobulin (IVIg) 5. any Janus kinase (JAK) inhibitor * History of deep venous thrombosis * Cardiovascular disease: 1. Coronary artery disease or history of myocardial infarction 2. Congestive heart failure with left ventricular ejection fraction ≤40% per American Heart Association guidelines 3. Stroke history * Hematologic malignancies including lymphoma and leukemia * Major surgery within 8 weeks prior to screening or will require major surgery during the study * Current or recent (\<4 weeks prior to randomization) clinically serious viral (including coronavirus disease 2019 (COVID-19)), bacterial, fungal, or parasitic infection or any other active or recent infection * Symptomatic herpes simplex at the time of randomization * Symptomatic herpes zoster infection within 12 weeks prior to randomization * History of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement) * Positive test for hepatitis B virus (HBV) defined as: 1. positive for hepatitis B surface antigen (HBsAg), or 2. positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) * Hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid \[RNA\]-positive) * Cirrhosis of the liver from any cause * Any of the following specific abnormalities on screening laboratory tests: 1. alanine transaminase (ALT) or aspartate aminotransferase (AST) \>2 x upper limits of normal (ULN) 2. alkaline phosphatase (ALP) ≥2 x ULN 3. total bilirubin ≥1.5 x ULN (with the exception of patients on atazanavir, who must have total bilirubin \<2 x ULN) * Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m\^2 * History of any (non-mood-related) psychotic disorder; active psychotic symptoms of any type; substance abuse/dependence within 6 months of study entry, as determined by severe combined immunodeficiency (SCID) * A positive urine drug screen for illicit drugs at any time during the study excluding marijuana * An active suicidal plan as determined by a score \>3 on item #3 on the Hamilton Rating Scale for Depression (HAM-D) * An active eating disorder or antisocial personality disorder * History of dementia * Chronic use of glucocorticoid containing medications or minocycline within 2 weeks of baseline or at any time during the study * Any contraindication for MRI scanning * Failure of more than 2 antidepressant trials (at least 6 weeks at recommended dose) in the current episode or 5 antidepressant trials lifetime * BMI \>42 (to exclude severe obesity) or at the investigator's discretion based on the patient's ability to fit in the MRI scanner

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

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