RecruitingPhase 4NCT06075771

Dopaminergic Therapy for Anhedonia - 2

Dopaminergic Therapy for Inflammation-Related Anhedonia in Depression - 2


Sponsor

Emory University

Enrollment

70 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a dopamine-boosting treatment approach to reduce anhedonia — a condition where a person loses the ability to feel pleasure. It is a symptom seen in depression and other mental health conditions. Researchers want to understand if targeting the dopamine system directly helps. **You may be eligible if...** - You are between 25 and 55 years old - You are a man or woman willing to provide written informed consent - You have a primary diagnosis of a DSM-5 mental health condition (such as major depressive disorder) - You score above a certain threshold on anhedonia rating scales **You may NOT be eligible if...** - You are outside the 25–55 age range - You do not have a confirmed DSM-5 diagnosis - You do not meet the minimum symptom severity threshold on the screening scales Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarbidopa 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.

DRUGPlacebo

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.


Locations(1)

Emory University Hospital

Atlanta, Georgia, United States

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NCT06075771


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