Inflammation and Depression in People With HIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
< 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
Trial design
Design model
Parallel
Treatments tested in this trial
Baricitinib
DrugPatients will receive baricitinib at a dose of 2 mg oral daily.
Placebo
Other interventionA placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 1 placebo tablet matching the baricitinib tablet.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: BaricitinibExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in corticostriatal functional connectivity (FC) in reward circuit
Patients will undergo resting-state and task-based functional magnetic resonance imaging (fMRI) to calculate functional connectivity (FC) between the ventral striatum (VS) and ventromedial prefrontal cortex (vmPFC). FC is measured as continuous Z scores reflecting the correlation of activity between the brain regions. Higher FC Z scores reflect stronger connectivity.
Time frame
Baseline visit, week 2, and week 10 after study medicationSecondary outcomes
1
Change in Effort Expenditure for Reward Task (EEfRT) Score
The EEfRT is a widely used, multi-trial task measuring motivation for rewards as an assessment of anhedonia, as anhedonia is specifically associated with decreased motivation for rewards. For each task participants repeatedly press a button to raise a "bar" on a screen. Before each task participants choose between between receiving a "hard task" (using the non-dominant little finger) for a larger reward or an "easy task" (using the dominant index finger) for a smaller reward. The EEfRT is reported as the proportion of "hard task" trials that participants select. Possible scores range between 0 to 1 with higher scores indicating greater motivation, which in turn is an indication for lower anhedonia.
Time frame
Baseline visit, week 2, and week 102
Change in Snaith-Hamilton Pleasure Scale-Self Report (SHAPS-SR) Score
The Snaith-Hamilton Pleasure Scale-Self Report (SHAPS-SR), a 14-item self-report scale with high psychometric validity for assessing the presence of anhedonia, is used to assess hedonic capacity. Participants rate how much they agree or disagree with 14 items phrased as "I would enjoy \_\_" based on their ability to experience pleasure. Of the four possible response categories (Definitely Agree, Agree, Disagree, and Strongly Disagree), either of the disagree responses receives a score of 1 and either of the agree responses receives a score of 0. The total SHAPS-SR score is calculated as the sum of these 14 items and ranges from 0 to 14, where higher SHAPS-SR scores indicate greater anhedonia.
Time frame
Baseline visit, week 1, week 2, week 4, week 6, and week 103
Change in Motivation and Pleasure Scale-Self-Report (MAP-SR) Score
The Motivation and Pleasure-Self-Report (MAP-SR) is an 18-item self-report inventory that was created to disentangle state-wise motivational and consummatory components of everyday activities over a 24-hour period. Participants respond to statements about daily activities on a 5-point Likert scale from 0 (no pleasure/not at all) to 4 (extreme pleasure/very often). Total scores range from 0 to 72 where higher scores indicate greater motivation and effort given to everyday situations.
Time frame
Baseline visit, week 1, week 2, week 4, week 6, and week 104
Change in Inventory of Depressive Symptoms Self Report (IDS-SR) Anhedonia Subscale Score
Anhedonia is assessed with a 3-item subscale of the Inventory of Depressive Symptomatology Self-Report (IDS-SR). Items are scored on a 4-point scale from 0 to 3. Total scores for the Anhedonia Subscale range from 0 to 9 with higher scores reflecting greater anhedonia.
Time frame
Baseline visit, week 1, week 2, week 4, week 6, and week 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov