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L-Dopa for Late-Life Depression (D3 Trial)
D3 Trial Summary
This trial is testing whether the drug L-DOPA can help improve symptoms of late-life depression, which is characterized by deficits in processing speed and executive function, as well as mobility impairments.
D3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowD3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.D3 Trial Design
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Who is running the clinical trial?
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- You have a history of severe mental health conditions like psychosis, mania, or bipolar disorder. However, if your main issue is depression and you have other mental health conditions, you may still be eligible.Your depression score on the MADRS scale is 15 or higher.I am currently on or recently stopped taking medication for mental health.You have had a bad reaction or allergy to L-DOPA medication in the past.I have severe joint pain or back issues that limit my ability to move.I walk slower than average or think slower than others my age.I have been diagnosed with a form of depression.You have shown signs of feeling extremely sad or having thoughts of hurting yourself.I am 60 years old or older.I have been diagnosed with HIV.I have slower thinking or walking speed than others my age.I have been diagnosed with a form of depression.I have a primary neurological disorder such as dementia, stroke, Parkinson's, or epilepsy.You have a medical condition that is not well controlled or stable.I have a disability that makes it hard for me to complete health assessments.You have been diagnosed with substance abuse or addiction, except for tobacco use, within the past year.
- Group 1: L-Dopa First / Placebo Second
- Group 2: Placebo First / L-Dopa Second
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What medical conditions may respond positively to L-Dopa treatment?
"L-Dopa is often prescribed to counteract manganese toxicity, as well as the symptoms of advanced motor fluctuations and carbon monoxide poisoning. It has also been used therapeutically for restless legs syndrome (RLS)."
Is the recruitment of participants ongoing for this experiment?
"According to information on clinicaltrials.gov, this clinical trial is currently recruiting participants; it was originally posted in February 2021 and most recently updated in the same month a year later."
How many participants are included in this research project?
"Affirmative. Data hosted on clinicaltrials.gov confirms that the trial, which was first opened for enrollment on February 15th 2021, is actively recruiting patients at this time. The study is searching for 60 participants from a single medical centre."
What previous experiments have been conducted involving L-Dopa?
"At the moment, there are 16 ongoing clinical trials related to L-Dopa with 4 of them in Phase 3. Most of these studies are occuring in Austin, Texas but participants around the world can participate as there is a total of 253 medical centres running this trial."
What did researchers intend to ascertain through this investigation?
"This experiment is designed to assess the alteration in WAIS-IV Coding Test Score over a Baseline to post-week 3 period. Secondary metrics include changes in NIH Toolbox Cognition Battery scores, MADRS (Montgomery Asberg Depression Rating Scale) score, and QIDS (Quick Inventory of Depressive Symptomatology) score. Each evaluation has its own range; higher values indicate greater severity."
Does the Food and Drug Administration recognize L-Dopa as a viable treatment option?
"As this clinical trial is in Phase 2, there are only limited safety data available on L-Dopa. Therefore, our team has assigned it a score of 2."
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