Dopaminergic Therapy for Depression with Anhedonia

Recruiting in Palo Alto (17 mi)

Overseen ByJennifer Felger, PhD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests L-DOPA, a medication that boosts dopamine, in people with depression who have high inflammation and can't feel pleasure. The goal is to see if increasing dopamine can improve their mood and ability to feel pleasure. L-DOPA is used to treat motor symptoms in Parkinson's disease by increasing dopamine levels in the brain.

Eligibility Criteria

This trial is for men and women aged 25-55 with depression, specifically those experiencing anhedonia (loss of pleasure) and high inflammation. Participants must have a certain score on the PHQ-9 questionnaire, not be on antidepressants or other psychotropic drugs for at least 4 weeks, and have no history of significant medical conditions or substance abuse.

Inclusion Criteria

I am between 25 and 55 years old.

I have been diagnosed with major depression.

I am between 25 and 55 years old.

I have been diagnosed with major depression.

Exclusion Criteria

I have or had an autoimmune disorder.

I have not had hepatitis B, C, or HIV, and no cancer history requiring major treatment.

My heart, blood, liver, kidney, hormone levels, and nervous system are stable.

I am not taking NSAIDs, glucocorticoids, or statins during the study.

I cannot have an MRI or take carbidopa-levodopa due to health issues.

Participant Groups

The study tests Carbidopa Levodopa's effectiveness against anhedonia in depressed individuals with high inflammation. Over six weeks, participants will receive varying doses of L-DOPA and placebos in different sequences to assess changes in their condition through lab tests, assessments, neurocognitive testing, and brain scans.

2Treatment groups

Experimental Treatment

Group I: Placebo followed by Carbidopa LevodopaExperimental Treatment2 Interventions

Participants will receive first placebo, and then Carbidopa Levodopa (L-DOPA) at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day.

Group II: Carbidopa Levodopa followed by PlaceboExperimental Treatment2 Interventions

Participants will receive first Carbidopa Levodopa at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day; and then placebo.

Carbidopa Levodopa is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Levodopa for: