Actively Recruiting

Phase 4
Age: 25Years - 55Years
All Genders
NCT06075771

Dopaminergic Therapy for Anhedonia - 2

Led by Emory University · Updated on 2026-01-28

70

Participants Needed

1

Research Sites

162 weeks

Total Duration

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Sponsors

E

Emory University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Dopaminergic Therapy for Anhedonia - 2

Who Can Participate

Age: 25Years - 55Years
All Genders

Eligibility Criteria

Eligible

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 confirmed by Structured Clinical Interview for DSM-5
  • 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 other psychotropic therapy for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine)
  • C-reactive protein (CRP) level of 2 mg/L or higher
  • PHQ-9 anhedonia score 2 or higher
Not Eligible

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 any cancer requiring more than minor surgery
  • Unstable cardiovascular, endocrine, hematologic, liver, kidney, or neurological disease
  • History of non-mood-related psychotic disorder, active psychotic symptoms, bipolar disorder, gambling disorder, or substance abuse/dependence within 6 months
  • Active suicidal plan with a 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 head injury with loss of consciousness
  • Pregnancy or lactation
  • 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 toxicology screen for drugs of abuse
  • Any contraindication for MRI scanning
  • Intolerance or contraindication to carbidopa-levodopa including certain eye, skin, gastrointestinal, bleeding disorders, or migraines

AI-Screening

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Trial Site Locations

Total: 1 location

1

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

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Research Team

J

Jennifer Felger, PhD

CONTACT

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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