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Dopaminergic Therapy for Depression with Anhedonia
Study Summary
This trial is looking at a new treatment for people with depression who also have high inflammation and anhedonia. The study will last for 6 weeks, and participants will be given different doses of the treatment (L-DOPA) or a placebo. They will be assessed through various tests and scans (lab tests, medical and psychiatric assessments, neurocognitive testing, functional MRI scans) to see if the treatment is effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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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?
Media Library
- I am not taking NSAIDs, glucocorticoids, or statins during the study.I regularly use NSAIDs, glucocorticoids, or statins.You have a score of 10 or more on the PHQ-9.You have a plan to harm yourself, and scored more than 3 on item #3 on the HAM-D. You also have an active eating disorder, except for those with binge eating disorder where binging makes their mood symptoms worse.I have not had hepatitis B, C, or HIV, and no cancer history requiring major treatment.I am between 25 and 55 years old.I have been diagnosed with major depression.I haven't taken any antidepressants or mood-related medications for 4 weeks, or 8 weeks for fluoxetine.You have a history of a condition affecting your ability to think or remember.My heart, blood, liver, kidney, hormone levels, and nervous system are stable.I am between 25 and 55 years old.I haven't taken any antidepressants or mood-related medications for the last 4 weeks.I have or had an autoimmune disorder.You have a history of mental illness that causes hallucinations or delusions, such as schizophrenia. You also have a history of bipolar disorder, gambling addiction, or drug abuse within the past 6 months.CRP ≥2 mg/L.I cannot have an MRI or take carbidopa-levodopa due to health issues.I have been diagnosed with major depression.
- Group 1: Carbidopa Levodopa followed by Placebo
- Group 2: Placebo followed by Carbidopa Levodopa
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Weeks after you stop receiving the treatment.
Frequently Asked Questions
Is this trial accepting new participants presently?
"According to clinicaltrials.gov, this research project is still recruiting patients since it was first posted on January 29th 2021 and updated most recently in March 3rd 2022."
What are the principal applications of Carbidopa Levodopa?
"Carbidopa Levodopa has been empirically proven to treat manganese intoxication, advanced motor fluctuations, and the often uncomfortable symptoms of restless legs syndrome (RLS)."
What is the approximate enrollment of this research study?
"Affirmative. The clinicaltrials.gov website displays that this experiment, which was initially posted on January 29th 2021, is currently inviting applicants to participate. 35 participants are needed from one medical centre for the study's completion."
Has Carbidopa Levodopa been certified by the FDA?
"With Phase 4 trial data available, our team has assigned Carbidopa Levodopa a score of 3 in regards to its safety. This drug is already approved for medical use."
Have any previous investigations explored the effects of Carbidopa Levodopa?
"Currently, 16 trials related to Carbidopa Levodopa are underway. Of those, 4 have reached Phase 3 of the trial process while the majority take place in Austin, Texas. In total 253 sites across North America are conducting studies for this drug."
What are the criteria for inclusion in this medical study?
"This clinical trial is actively looking for 35 people, aged 25 to 55 and diagnosed with anhedonia. To be eligible for the study, participants must provide written consent, have a DSM-V MD diagnosis that can be verified through SCID-I assessments, have a PHQ-9 score of more than 10; not take any psychotropic medications such as antidepressant or other therapies like mood stabilizers four weeks prior to visit (eight weeks in case of fluoxetine), CRP levels >/=2 mg/L and PHQ-9 Anhedonin Question Score greater than or equal to 2."
Is this experiment open to individuals over four decades of age?
"This medical trial limits its recruitment to patients aged 25-55. Separately, there are 193 studies available for minors and 978 trials worldwide accepting senior citizens as participants."
Who else is applying?
How old are they?
What portion of applicants met pre-screening criteria?
What state do they live in?
What site did they apply to?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Emory University Hospital: < 48 hours
Average response time
- < 2 Days
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