What side effects are associated with this type of intervention?

Common treatments for anhedonia that increase dopamine levels, such as L-DOPA, can have several side effects. These may include nausea, dizziness, headaches, and fluctuations in mood and anxiety levels. Additionally, treatments like L-DOPA can cause motor complications such as dyskinesias (involuntary movements) and may lead to neuropsychiatric side effects, including hallucinations and impulse control disorders. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

There are no specific FDA approvals for the treatment of anhedonia alone, as it is typically a symptom of broader conditions such as depression. However, treatments that increase dopamine levels, like L-DOPA, are being studied for their potential benefits. Currently, dopaminergic agents such as bupropion, which is FDA-approved for depression, are used off-label to address symptoms of anhedonia by enhancing dopamine activity in the brain.

What other types of research exist?

Promising alternatives to L-DOPA for anhedonia include dopaminergic therapies such as pramipexole and ropinirole, which have shown efficacy in early Parkinson's disease and may benefit anhedonia. Additionally, safinamide, a monoamine oxidase B inhibitor, has shown potential in improving non-motor symptoms like anhedonia. Further research and clinical trials are needed to confirm their efficacy specifically for anhedonia.

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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

Pivotal Trial

Drug Has Already Been Approved

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 days9 visits

Treatment ~ 6 weeks6 visits

Follow Up ~ 0 weeks0 visits

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

0 / 9Eligibility criteria met

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.