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Dopaminergic Therapy

Dopaminergic Therapy for Depression with Anhedonia

Phase 4
Recruiting
Led By Jennifer Felger, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
men or women, 25-55 years of age
a primary diagnosis of DSM-V MD, current, as diagnosed by the SCID-I;
Must not have
history or evidence (clinical or laboratory) of an autoimmune disorder ;
history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection; - history of any type of cancer requiring treatment with more than minor surgery;
Timeline
Screening 3 days
Treatment 6 weeks
Follow Up 0 weeks
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from Carbidopa Levodopa may include nausea, dizziness upon standing up quickly due to low blood pressure (orthostatic hypotension), involuntary movements (dyskinesia), dry mouth, trouble sleeping (insomnia), constipation or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 55 years old.
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I have been diagnosed with major depression.
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I am between 25 and 55 years old.
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I have been diagnosed with major depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had an autoimmune disorder.
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I have not had hepatitis B, C, or HIV, and no cancer history requiring major treatment.
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My heart, blood, liver, kidney, hormone levels, and nervous system are stable.
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I am not taking NSAIDs, glucocorticoids, or statins during the study.
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I cannot have an MRI or take carbidopa-levodopa due to health issues.

Timeline

Screening ~ 3 days
Treatment ~ 6 weeks
Follow Up ~0 weeks
This trial's timeline: 3 days for screening, 6 weeks for treatment, and 0 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in targeted ventral striatum to ventromedial prefrontal cortex (VS-vmPFC) connectivity
Secondary study objectives
Change in Effort-Expenditure for Rewards Task (EEfRT)
Change in Hamilton Depression Rating Scale (HAM-D)
Change in Inventory of Depressive Symptomatology- Self-Report (IDS-SR)
+2 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Carbidopa Levodopa
2018
Completed Phase 1
~20

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Anhedonia, characterized by a diminished ability to experience pleasure, is often linked to dysregulation in the brain's reward system, particularly involving dopamine. Treatments like L-DOPA, which increases dopamine levels, aim to enhance dopaminergic transmission and improve reward processing. Other common treatments include dopaminergic agents such as bupropion, which inhibits the reuptake of dopamine and norepinephrine, and psychostimulants like methylphenidate, which increase dopamine availability. These treatments are crucial for anhedonia patients as they target the underlying neurochemical deficits, potentially restoring the ability to experience pleasure and improving overall quality of life.

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,679 Previous Clinical Trials
2,583,631 Total Patients Enrolled
4 Trials studying Anhedonia
448 Patients Enrolled for Anhedonia
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,501 Total Patients Enrolled
17 Trials studying Anhedonia
1,807 Patients Enrolled for Anhedonia
Jennifer Felger, PhDPrincipal Investigator - Emory University
Emory University
3 Previous Clinical Trials
187 Total Patients Enrolled
2 Trials studying Anhedonia
130 Patients Enrolled for Anhedonia

Media Library

Carbidopa Levodopa (Dopaminergic Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04723147 — Phase 4
Anhedonia Research Study Groups: Carbidopa Levodopa followed by Placebo, Placebo followed by Carbidopa Levodopa
Anhedonia Clinical Trial 2023: Carbidopa Levodopa Highlights & Side Effects. Trial Name: NCT04723147 — Phase 4
Carbidopa Levodopa (Dopaminergic Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04723147 — Phase 4
~8 spots leftby Nov 2025
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