Recruiting

Dopaminergic Therapy

Sponsor:

Emory University

Code:

NCT06075771

Conditions

Anhedonia

Depression

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Not accepted

Interventions

Carbidopa Levodopa

Placebo

Study Details

Brief summary:

The purpose of this 8-week, double-blind, placebo-controlled, study is to explore new treatment options for people with depression who have high inflammation and anhedonia. Seventy male and female participants with depression, between 25-55 years of age, with higher levels of inflammation and anhedonia will be randomized to receive L-DOPA or matched placebo over 8 weeks. Participants will complete lab tests, medical and psychiatric assessments, motivation and motor tasks, and MRI scans as part of the study. The total length of participation is approximately 10 to 12 weeks.

Conditions

Anhedonia

Depression

Study ID

NCT06075771

Start date

Nov 21, 2023

Status verified date

Jan, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Carbidopa Levodopa Group

Patients randomized to the Carbidopa Levodopa Group will receive one tablet per day of L-DOPA (150 mg levodopa administered with 37.5 mg carbidopa) for 4 weeks.

Patients that respond after the initial 4 weeks will continue on the same dose for an additional 4 weeks to determine whether clinical response at the 150 mg dose is sustained over time compared to placebo.

Patients that do not exhibit a clinical response (50% reduction in HAM-D scores from baseline) after 4-weeks on the 150 mg dose will escalate to 450 mg L-DOPA (three tablets per day of 150 mg levodopa administered with 37.5 mg carbidopa) and studied over an additional 4 weeks (8 weeks total in the study).

placebo comparator: Placebo Group

Participants will receive placebo tablet. Placebo-treated non-responders at 4 weeks will remain on placebo but with the same instructions to increase daily pill intake.

Interventions

Carbidopa Levodopa

Patients will receive between one and three tablets per day of 150 mg L-DOPA (administered with 37.5 mg carbidopa) to achieve doses ranging from 150 to 450 mg/day.

Placebo

A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive between one and three placebo tablets per day matching the Carbidopa Levodopa tablet.

Primary outcome measure

  • Change in depressive symptom severity measured by Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Baseline, weeks 1-4 post-intervention, weeks 5-8 post-intervention ]

Central Contacts and Locations

Central contacts

Jennifer Felger, PhD

4047273987jfelger@emory.edu

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Jennifer Felger, PhD

4047273987jfelger@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • Anhedonia
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-01-28.