Dopaminergic Therapy for Depression with Anhedonia
(DTA-2 Trial)
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking all antidepressant or other psychotropic medications (like mood stabilizers, antipsychotics, and sedatives) for at least 4 weeks before the study starts (8 weeks for fluoxetine). You also cannot use NSAIDs, glucocorticoids, or statins during the study.
What data supports the effectiveness of the drug Carbidopa Levodopa for depression with anhedonia?
Research shows that Carbidopa Levodopa is effective in treating Parkinson's disease by improving symptoms and quality of life. Although not directly related to depression, its ability to enhance dopamine levels might suggest potential benefits for conditions like depression with anhedonia, which involves a lack of pleasure.12345
Is dopaminergic therapy with Carbidopa Levodopa safe for humans?
How does the drug Carbidopa Levodopa differ from other treatments for depression with anhedonia?
Carbidopa Levodopa is unique because it targets dopamine levels in the brain, which is a different approach compared to typical antidepressants that often focus on serotonin. This drug is traditionally used for Parkinson's disease to manage dopamine deficiency, and its use for depression with anhedonia is novel, as it may help address dopamine-related symptoms.1891011
What is the purpose of this trial?
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.
Research Team
Jennifer Felger, PhD
Principal Investigator
Emory University
Eligibility Criteria
This trial is for men and women aged 25-55 with depression, specifically those who experience a lack of pleasure (anhedonia) and have high inflammation levels. Participants must not be on antidepressants or other psychotropic drugs for at least 4 weeks, have a CRP level ≥2 mg/L, and score highly on specific depression scales. Pregnant individuals, those with certain medical conditions or medication intolerances, substance abuse issues, or positive drug tests are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive L-DOPA or placebo for 8 weeks, with assessments including lab tests, medical and psychiatric evaluations, motivation and motor tasks, and MRI scans.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carbidopa Levodopa
- Placebo
Carbidopa Levodopa is already approved in European Union, United States, Canada, Japan for the following indications:
- Parkinson's disease
- Dopamine-responsive dystonia
- Restless legs syndrome
- Parkinson's disease
- Dopamine-responsive dystonia
- Restless legs syndrome
- Parkinson's disease
- Dopamine-responsive dystonia
- Restless legs syndrome
- Parkinson's disease
- Dopamine-responsive dystonia
- Restless legs syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator