Actively Recruiting
Dopaminergic Therapy for Inflammation-Related Anhedonia in Depression - 2
Led by Emory University · Updated on 2026-01-28
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying new treatment options for adults aged 25 to 55 who have depression characterized by high inflammation and anhedonia, which is the inability to feel pleasure. This 8-week, double-blind, placebo-controlled trial explores the effects of an FDA-approved medication called Sinemet (L-DOPA) in this specific group of people. The study aims to better understand whether L-DOPA affects brain circuits related to motivation and reward in depression. Participants will be randomly assigned to receive either L-DOPA or a placebo. Those in the L-DOPA group will start with one tablet daily containing 150 mg levodopa and 37.5 mg carbidopa for 4 weeks. Responders continue this dose for another 4 weeks, while non-responders increase to three tablets daily (450 mg levodopa total) for the remaining 4 weeks. Placebo group participants follow the same schedule but take sugar pills instead. This dosing strategy helps evaluate how different amounts of the drug may influence symptoms over time. During the trial, participants will undergo medical and psychiatric assessments, lab tests, motivation and motor function tasks, and MRI scans at various points. Researchers will measure changes in depression severity using the Hamilton Depression Rating Scale and track brain activity related to motivation and pleasure. The total participation lasts about 10 to 12 weeks, including screening and follow-up, to monitor safety and treatment effects thoroughly.
CONDITIONS
Brief Title
Dopaminergic Therapy for Anhedonia - 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give written informed consent
- Men or women aged 25 to 55 years
- Primary diagnosis of current depression as per DSM-5 criteria
- Patient Health Questionnaire-9 (PHQ-9) score greater than 10 or Hamilton Depression Rating Scale (HAM-D) score 18 or higher
- Off all antidepressant or psychotropic medications for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine)
- C-reactive protein (CRP) level 2 mg/L or higher
- PHQ-9 anhedonia score 2 or higher
You will not qualify if you...
- History or evidence of autoimmune disorders
- History or evidence of hepatitis B, hepatitis C, or HIV infection
- History of cancer requiring more than minor surgery
- Unstable cardiovascular, endocrine, hematologic, liver, kidney, or neurologic disease
- History of non-mood-related psychotic disorders, current psychotic symptoms, bipolar disorder, gambling disorder, or substance abuse within 6 months
- Active suicidal plan indicated by HAM-D item #3 score greater than 3
- Active eating disorder (except binge eating disorder linked to mood symptoms)
- History of cognitive disorder or traumatic brain injury with loss of consciousness
- Pregnancy or breastfeeding
- Use of gender affirming hormone therapy
- Chronic use of NSAIDs (except low-dose aspirin), glucocorticoids, or statins
- Use of NSAIDs, glucocorticoids, or statins during the study
- Positive urine screen for drugs of abuse
- Contraindications to MRI scanning
- Sensitivity or contraindication to carbidopa-levodopa, including history of narrow-angle glaucoma, melanoma, ulcers, bleeding disorders, or frequent migraines
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive daily doses of either L-DOPA or placebo for 8 weeks. Those responding to the initial 4 weeks of treatment continue the same dose, while non-responders increase their dose for the remaining 4 weeks.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
J
Jennifer Felger, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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