Exploring L-DOPA for treating depression and anhedonia
Dopaminergic Therapy for Inflammation-Related Anhedonia in Depression - 2
This study is testing if L-DOPA can help people aged 25-55 with depression and lack of pleasure feel better over 8 weeks compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 25 Years to 55 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06075771 on ClinicalTrials.gov |
What this trial studies
This 8-week, double-blind, placebo-controlled study investigates the effects of L-DOPA on individuals aged 25-55 who suffer from depression characterized by high inflammation and anhedonia. Seventy participants will be randomized to receive either L-DOPA or a matched placebo, with assessments including lab tests, medical evaluations, motivation tasks, and MRI scans. The study aims to determine if L-DOPA, an FDA-approved medication, can effectively target the biological pathways associated with depression and anhedonia. The total duration of participation is approximately 10 to 12 weeks.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 25-55 with a primary diagnosis of depression, high inflammation levels, and significant anhedonia.
Not a fit: Patients with autoimmune disorders, certain infections, or a history of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with depression who experience anhedonia and high inflammation.
How similar studies have performed: While existing dopaminergic therapies have been used in other contexts, this specific approach targeting inflammation-related anhedonia in depression is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * a. willing and able to give written informed consent * b. men or women, 25-55 years of age * c. a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), current, as diagnosed by the Structured Clinical Interview for DSM-5 * d. score of \>10 on the Patient Health Questionnaire-9 (PHQ-9) or HAM-D score ≥18 * e. off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, anxiolytics, and sedative hypnotics) for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine) * f. c-reactive protein (CRP) ≥2 mg/L * g. PHQ-9 anhedonia score ≥2 Exclusion Criteria: * a. history or evidence (clinical or laboratory) of an autoimmune disorder * b. history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection * c. history of any type of cancer requiring treatment with more than minor surgery * d. unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination, EKG and laboratory testing) * e. history of any (non-mood-related) psychotic disorder; active psychotic symptoms of any type; history or current bipolar disorder; history or current gambling disorder; substance abuse/dependence within 6 months of study entry (as determined by standardized clinician interview) * f. active suicidal plan as determined by a score \>3 on item #3 on the HAM-D * g. an active eating disorder (except for patients with binge eating disorder in whom binging is clearly associated with worsening of mood symptoms) * h. a history of a cognitive disorder or traumatic head injury involving loss of consciousness * i. pregnancy or lactation * j. use of gender affirming hormone therapy * k. chronic use of non-steroidal anti-inflammatory agents (NSAIDS) (excluding 81mg of aspirin), glucocorticoid containing medications or statins * l. use of NSAIDS, glucocorticoids, or statins at any time during the study * m. urine toxicology screen is positive for drugs of abuse, n. any contraindication for MRI scanning * o. intolerance, sensitivity or contraindication to carbidopa-levodopa (including history of narrow-angle glaucoma, melanoma, gastric and/or duodenal ulcers, bleeding disorders, or frequent migraines)
Where this trial is running
Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Felger, PhD — Emory University
- Study coordinator: Jennifer Felger, PhD
- Email: jfelger@emory.edu
- Phone: 4047273987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.