HIVPhase 2NCT05849038
Inflammation and Depression in People With HIV
A Phase 2 study testing Baricitinib in people with HIV and Depression, run by Emory University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV, Depression, Anhedonia
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Dec 2023to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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:
Show all 41Show fewer
- Oral corticosteroids
- Biologic treatments such as etanercept, infliximab, certolizumab, adalimumab, golimumab, tocilizumab, abatacept, Ustekinumab, ixekizumab, secukinumab, or anakinra
- Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-interferon (IFN) therapy)
- Rituximab, any other B cell depleting therapies, or intravenous immunoglobulin (IVIg)
- any Janus kinase (JAK) inhibitor
- History of deep venous thrombosis
- Cardiovascular disease:
- Coronary artery disease or history of myocardial infarction
- Congestive heart failure with left ventricular ejection fraction ≤40% per American Heart Association guidelines
- 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:
- positive for hepatitis B surface antigen (HBsAg), or
- 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:
- alanine transaminase (ALT) or aspartate aminotransferase (AST) >2 x upper limits of normal (ULN)
- alkaline phosphatase (ALP) ≥2 x ULN
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
Vincent C Marconi, MD, 404-616-0673, vcmarco@emory.edu
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Andrew H Miller, MD, (404) 727-8260, amill02@emory.edu
About this study
Official title: The Role of Inflammation in Central Nervous System (CNS) Mechanisms of Anhedonia and Psychomotor Slowing in Depressed People With HIV
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.
Read the detailed description
Risk of depression is substantially higher in people with HIV (PWH) than the general population, and depression in PWH confers worse outcomes regarding treatment adherence, morbidity, and mortality. Increased inflammation is one biological pathway that is linked to greater risk for depression in PWH and limits options for effective antidepressant therapy. Chronically elevated inflammation is associated with impairments within reward and motor neural circuits that contribute to symptoms of anhedonia (an inability to experience pleasure) and psychomotor slowing, which are overrepresented in PWH. The purpose of this 10-week, double-blind, placebo-controlled study is to provide mechanistic information on whether inflammation impacts corticostriatal reward and motor circuitry to contribute to anhedonia and psychomotor slowing in PWH with depression using the anti-inflammatory drug baricitinib.
This study will utilize an FDA-approved medication, baricitinib, to establish whether the effects of inflammation on reward and motor circuits are a mechanism of anhedonia and motor slowing in PWH with depression, while advancing avenues for new therapies.
Sixty male and female patients with HIV who have depression and high inflammation and are stable on effective treatment for their HIV will be randomized to receive either 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.
- Conditions
- HIV, Depression, Anhedonia
- Being tested
- Baricitinib, Placebo
- Keywords
- Human Immunodeficiency Virus (HIV), Anhedonia, Psychomotor Slowing
- Medical subject headings
- Depression, Anhedonia, Acquired Immunodeficiency Syndrome, Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called Olumiant
Patients will receive baricitinib at a dose of 2 mg oral daily.
PlaceboOther
A 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.
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | Experimental | Participants will be randomized to receive 10 weeks of treatment with baricitinib. Receives: Drug: Baricitinib |
| Placebo | Placebo comparator | Participants will be randomized to receive 10 weeks of treatment with placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline visit, week 2, and week 10 after study medication
Secondary outcomes (10)
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.
Measured: Baseline visit, week 2, and week 10
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.
Measured: Baseline visit, week 1, week 2, week 4, week 6, and week 10
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.
Measured: Baseline visit, week 1, week 2, week 4, week 6, and week 10
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.
Measured: Baseline visit, week 1, week 2, week 4, week 6, and week 10
Change in Multidimensional Fatigue Inventory (MFI) Score
The Multidimensional Fatigue Inventory (MFI) assesses 5 dimensions of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation. Participants read 20 statements (such as "I feel very active") and indicate how true that feeling is for them on a 5-point scale where "yes, that is true" = 1 and "no, that is not true" = 5. Total scores range from 20 to 100 and higher scores indicate greater fatigue.
Measured: Baseline visit, week 1, week 2, week 4, week 6, and week 10
Change in Finger Tapping Task (FTT) Mean Number of Taps
The Finger Tapping Task (FTT) uses a specially adapted tapper that the participant taps as fast as possible using the index finger. The participant is given 5 consecutive 10-second trials for the preferred and non-preferred hands. The FTT score is calculated as the mean number of taps for the preferred and non-preferred hands. The FTT is designed to assess subtle motor impairment and is altered in subjects with basal ganglia disorders and lesions. A lower score indicates motor impairment.
Measured: Baseline visit, week 2, and week 10
Change in Finger Tapping Task (FTT) Total Number of Taps
The Finger Tapping Task (FTT) uses a specially adapted tapper that the participant taps as fast as possible using the index finger. The participant is given 5 consecutive 10-second trials for the preferred and non-preferred hands. The FTT score is calculated as the total number of taps for the preferred and non-preferred hands. The FTT is designed to assess subtle motor impairment and is altered in subjects with basal ganglia disorders and lesions. A lower score indicates motor impairment.
Measured: Baseline visit, week 2, and week 10
Change in Trail Making Test Part A (TMT-A) Score
The Trail Making Test Part A (TMT-A) measures psychomotor processing speed by asking participants to accurately draw lines connecting circles printed on a piece of paper as quickly as possible. In Part A, participants connect 25 circles in numeric sequence and the test is scored as the time in seconds that it takes to complete. Higher scores (i.e., time) indicate poorer performance.
Measured: Baseline visit, week 2, and week 10
Change in Trail Making Test Part B (TMT-B) Score
The Trail Making Test Part B (TMT-B) measures psychomotor speed, attention, and cognitive sequencing. Participants connect a series of randomly arranged circles in a designated sequential order, based on alternating numbers and letters letters (i.e., 1 to A to 2 to B, etc.) on paper. The test is scored as the time in seconds that it takes to complete. Higher scores (i.e., time) indicate poorer performance.
Measured: Baseline visit, week 2, and week 10
Change in Digit Symbol Substitution Test (DSST) Score
The Digit Symbol Substitution Test (DSST) is a test of psychomotor speed, concentration, and graphomotor abilities that asks the respondent to match symbols to numbers as quickly as possible, using a visual reference. The examinee's score is determined by the number of symbols correctly drawn on paper within the 120 second time limit.
Measured: Baseline visit, week 2, and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start11 Dec 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Andrew H Miller, Emory University
- Investigators
- Andrew H Miller, MD, Principal investigator, Emory UniversityJennifer Felger, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849038
- Sponsor's protocol ID
- STUDY00005526
- Other IDs
- 5R01MH128872-03, 2025P011788
- Status last verified
- May 2026
- First submitted
- 27 Apr 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be made available for sharing through the National Institute of Mental Health Data Archive (NDA) data sharing platform hosted by the National Institute of Mental Health (NIMH).
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Inflammation in Central Nervous System (CNS) Mechanisms of Anhedonia and Psychomotor Slowing in Depressed People With HIV
- ClinicalTrials.gov ID
- NCT05849038
- Acronym / sponsor ID
- STUDY00005526
- Conditions
- HIV, Depression, Anhedonia
- Keywords
- Human Immunodeficiency Virus (HIV), Anhedonia, Psychomotor Slowing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Risk of depression is substantially higher in people with HIV (PWH) than the general population, and depression in PWH confers worse outcomes regarding treatment adherence, morbidity, and mortality. Increased inflammation is one biological pathway that is linked to greater risk for depression in PWH and limits options for effective antidepressant therapy. Chronically elevated inflammation is associated with impairments within reward and motor neural circuits that contribute to symptoms of anhedonia (an inability to experience pleasure) and psychomotor slowing, which are overrepresented in PWH. The purpose of this 10-week, double-blind, placebo-controlled study is to provide mechanistic information on whether inflammation impacts corticostriatal reward and motor circuitry to contribute to anhedonia and psychomotor slowing in PWH with depression using the anti-inflammatory drug baricitinib.
This study will utilize an FDA-approved medication, baricitinib, to establish whether the effects of inflammation on reward and motor circuits are a mechanism of anhedonia and motor slowing in PWH with depression, while advancing avenues for new therapies.
Sixty male and female patients with HIV who have depression and high inflammation and are stable on effective treatment for their HIV will be randomized to receive either 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | Experimental | Drug: BaricitinibParticipants will be randomized to receive 10 weeks of treatment with baricitinib. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be randomized to receive 10 weeks of treatment with placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (41 listed)
- < 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibAlso: OlumiantPatients will receive baricitinib at a dose of 2 mg oral daily. | Drug | Baricitinib |
| PlaceboA 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. | Other | Placebo |
Primary outcome
Change in corticostriatal functional connectivity (FC) in reward circuit
Time frame: Baseline visit, week 2, and week 10 after study medication
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.
10 secondary outcomes
Change in Effort Expenditure for Reward Task (EEfRT) Score
Time frame: Baseline visit, week 2, and week 10
Change in Snaith-Hamilton Pleasure Scale-Self Report (SHAPS-SR) Score
Time frame: Baseline visit, week 1, week 2, week 4, week 6, and week 10
Change in Motivation and Pleasure Scale-Self-Report (MAP-SR) Score
Time frame: Baseline visit, week 1, week 2, week 4, week 6, and week 10
Change in Inventory of Depressive Symptoms Self Report (IDS-SR) Anhedonia Subscale Score
Time frame: Baseline visit, week 1, week 2, week 4, week 6, and week 10
Change in Multidimensional Fatigue Inventory (MFI) Score
Time frame: Baseline visit, week 1, week 2, week 4, week 6, and week 10
Change in Finger Tapping Task (FTT) Mean Number of Taps
Time frame: Baseline visit, week 2, and week 10
Change in Finger Tapping Task (FTT) Total Number of Taps
Time frame: Baseline visit, week 2, and week 10
Change in Trail Making Test Part A (TMT-A) Score
Time frame: Baseline visit, week 2, and week 10
Change in Trail Making Test Part B (TMT-B) Score
Time frame: Baseline visit, week 2, and week 10
Change in Digit Symbol Substitution Test (DSST) Score
Time frame: Baseline visit, week 2, and week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be made available for sharing through the National Institute of Mental Health Data Archive (NDA) data sharing platform hosted by the National Institute of Mental Health (NIMH).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew H Miller, MD principal investigator
Emory University
Jennifer Felger, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib in people with HIV and Depression, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Felger, PhD (404-727-3987, jfelger@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in corticostriatal functional connectivity (FC) in reward circuit (time frame: Baseline visit, week 2, and week 10 after study medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.