RECRUITING

Inflammation and Depression in People With HIV

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Conditions

HIVDepressionAnhedoniaHuman Immunodeficiency Virus (HIV)Psychomotor Slowing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Role of Inflammation in Central Nervous System (CNS) Mechanisms of Anhedonia and Psychomotor Slowing in Depressed People With HIV

Quick Facts

Study Start:2023-12-11
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05849038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * 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)
  3. * 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
  4. * Score of ≥10 on the 9-item Patient Health Questionnaire (PHQ-9)
  5. * 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
  6. * Significant anhedonia as reflected by a score ≥ 2 on item #1 of the PHQ-9
  7. * CRP≥2mg/L
  8. * Women of reproductive age will have a negative serum pregnancy test at study entry and both mend and women must agree to adequate contraception while
  1. * \< 18 years of age or \> 65 years of age
  2. * Pregnancy or breastfeeding
  3. * Significant hematological abnormalities at screening (ANC \< 1500, Hgb\<10, platelet\< 100,000)
  4. * History of progressive multifocal leukoencephalopathy
  5. * Untreated latent tuberculosis infection (which will be screened for prior to entry)
  6. * Having taken the following immunosuppressive medications within the past 6 months:
  7. 1. Oral corticosteroids
  8. 2. Biologic treatments such as etanercept, infliximab, certolizumab, adalimumab, golimumab, tocilizumab, abatacept, Ustekinumab, ixekizumab, secukinumab, or anakinra
  9. 3. Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-interferon (IFN) therapy)
  10. 4. Rituximab, any other B cell depleting therapies, or intravenous immunoglobulin (IVIg)
  11. 5. any Janus kinase (JAK) inhibitor
  12. * History of deep venous thrombosis
  13. * Cardiovascular disease:
  14. 1. Coronary artery disease or history of myocardial infarction
  15. 2. Congestive heart failure with left ventricular ejection fraction ≤40% per American Heart Association guidelines
  16. 3. Stroke history
  17. * Hematologic malignancies including lymphoma and leukemia
  18. * Major surgery within 8 weeks prior to screening or will require major surgery during the study
  19. * 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
  20. * Symptomatic herpes simplex at the time of randomization
  21. * Symptomatic herpes zoster infection within 12 weeks prior to randomization
  22. * History of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement)
  23. * Positive test for hepatitis B virus (HBV) defined as:
  24. 1. positive for hepatitis B surface antigen (HBsAg), or
  25. 2. positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA)
  26. * Hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid \[RNA\]-positive)
  27. * Cirrhosis of the liver from any cause
  28. * Any of the following specific abnormalities on screening laboratory tests:
  29. 1. alanine transaminase (ALT) or aspartate aminotransferase (AST) \>2 x upper limits of normal (ULN)
  30. 2. alkaline phosphatase (ALP) ≥2 x ULN
  31. 3. total bilirubin ≥1.5 x ULN (with the exception of patients on atazanavir, who must have total bilirubin \<2 x ULN)
  32. * Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m\^2
  33. * 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)
  34. * A positive urine drug screen for illicit drugs at any time during the study excluding marijuana
  35. * An active suicidal plan as determined by a score \>3 on item #3 on the Hamilton Rating Scale for Depression (HAM-D)
  36. * An active eating disorder or antisocial personality disorder
  37. * History of dementia
  38. * Chronic use of non-steroidal anti-inflammatory agents (NSAIDS) (excluding 81mg of aspirin), glucocorticoid containing medications or minocycline within 2 weeks of baseline or at any time during the study
  39. * Any contraindication for MRI scanning
  40. * Failure of more than 2 antidepressant trials (at least 6 weeks at recommended dose) in the current episode or 5 antidepressant trials lifetime
  41. * BMI \>42 (to exclude severe obesity) or at the investigator's discretion based on the patient's ability to fit in the MRI scanner

Contacts and Locations

Study Contact

Jennifer Felger, PhD
CONTACT
404-727-3987
jfelger@emory.edu

Principal Investigator

Andrew H Miller, MD
PRINCIPAL_INVESTIGATOR
Emory University
Jennifer Felger, PhD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Grady Memorial Hospital
Atlanta, Georgia, 30303
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Andrew H Miller, MD, PRINCIPAL_INVESTIGATOR, Emory University
  • Jennifer Felger, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-11
Study Completion Date2027-11

Study Record Updates

Study Start Date2023-12-11
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • Human Immunodeficiency Virus (HIV)
  • Anhedonia
  • Psychomotor Slowing

Additional Relevant MeSH Terms

  • HIV
  • Depression
  • Anhedonia