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Dopamine Precursor

L-Dopa for Late-Life Depression (D3 Trial)

Phase 2
Recruiting
Led By Warren Taylor, MD,MHSc
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Decreased processing speed (1 standard deviation below age-adjusted norms on the Digit Symbol test) or decreased gait speed (average walking speed on 15' course < 1m/s)
Diagnostic and Statistical Manual-5 (DSM5) diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depression Not Otherwise Specified (NOS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after week 3, and after week 6
Awards & highlights

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.

Who is the study for?
This trial is for adults aged 60 or older with late-life depression, who have slower mental processing or walking speed. They must be able to consent and follow the study's procedures. Excluded are those at high suicide risk, allergic to L-DOPA, recently on certain psychiatric meds, with mobility issues due to joint/spine problems, major neurological disorders like dementia or Parkinson's, unstable illnesses, substance abuse within a year, or other primary psychiatric conditions.Check my eligibility
What is being tested?
The study tests whether carbidopa/levodopa (L-DOPA), which enhances dopamine in the brain can improve symptoms of depression by speeding up thinking and movement in older adults. Participants will either receive L-DOPA or a placebo without active ingredients to compare effects.See study design
What are the potential side effects?
Potential side effects of L-DOPA may include nausea, dizziness upon standing up quickly (orthostatic hypotension), involuntary movements (dyskinesia), dry mouth, trouble sleeping (insomnia), and confusion.

D3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I walk slower than average or think slower than others my age.
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I have been diagnosed with a form of depression.
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I am 60 years old or older.
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I have slower thinking or walking speed than others my age.
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I have been diagnosed with a form of depression.

D3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after week 3, and after week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after week 3, and after week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Effort Expenditure for Rewards Task (EEfRT)
Change in Gait pattern
Change in Letter Comparison Test Score
+3 more
Secondary outcome measures
Change in MADRS (Montgomery Asberg Depression Rating Scale) Score
Change in NIH Toolbox Cognition Battery Scores
Change in QIDS (Quick Inventory of Depressive Symptomatology) Score
+1 more

D3 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: L-Dopa First / Placebo SecondExperimental Treatment2 Interventions
STEP 1(3 weeks): Participants initially assigned to L-DOPA will begin with a Week 1 L-DOPA daily dosage of 150mg, (1.5 25mg carbidopa/100mg levodopa capsules) at 9am. Week 2 will increase to a L-DOPA daily dose of 300mg (1.5 25mg carbidopa/100mg levodopa capsules) at 9am and 5pm, followed by a Week 3 L-DOPA daily dose of 450mg (1.5 25mg carbidopa/100mg levodopa capsules) three times daily. After completing post-trial assessments, participants then enter a 1 week taper period before proceeding to Step 2. Step 2 (3 Weeks): Participants will receive matching placebo capsules daily. Participants take placebo capusles once daily during week 1 (9am), twice daily during week 2 (9am, 5pm), and three times daily during week 3 (9am, 1pm, 5pm) over three weeks. Following post-trial assessments, participants then enter a 1-week taper period and study drug is withdrawn.
Group II: Placebo First / L-Dopa SecondPlacebo Group2 Interventions
Step 1 (3 Weeks): Participants will receive matching placebo capsules daily. Participants take placebo capsules once daily during week 1 (9am), twice daily during week 2 (9am, 5pm), and three times daily during week 3 (9am, 1pm, 5pm) over three weeks. Following post-trial assessments, participants then enter a 1-week taper period before proceeding to Step 2. Step 2 (3 Weeks): Participants will begin with a Week 1 L-DOPA daily dosage of 150mg, (1.5 25mg carbidopa/100mg levodopa capsules) at 9am. Week 2 will increase to a L-DOPA daily dose of 300mg (1.5 25mg carbidopa/100mg levodopa capsules) at 9am and 5pm, followed by a Week 3 L-DOPA daily dose of 450mg (1.5 25mg carbidopa/100mg levodopa capsules) three times daily. After completing post-trial assessments, participants then enter a 1 week taper period and study drug will be discontinued.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
L-Dopa
2011
Completed Phase 3
~30

Find a Location

Who is running the clinical trial?

University of PittsburghOTHER
1,716 Previous Clinical Trials
16,346,354 Total Patients Enrolled
University of Pittsburgh Medical CenterOTHER
70 Previous Clinical Trials
76,150 Total Patients Enrolled
Rutgers UniversityOTHER
113 Previous Clinical Trials
2,803,999 Total Patients Enrolled

Media Library

L-Dopa (Dopamine Precursor) Clinical Trial Eligibility Overview. Trial Name: NCT04469959 — Phase 2
Late-Life Depression Research Study Groups: L-Dopa First / Placebo Second, Placebo First / L-Dopa Second
Late-Life Depression Clinical Trial 2023: L-Dopa Highlights & Side Effects. Trial Name: NCT04469959 — Phase 2
L-Dopa (Dopamine Precursor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04469959 — Phase 2
Late-Life Depression Patient Testimony for trial: Trial Name: NCT04469959 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Vanderbilt Psychiatric Hospital
University of Pittsburgh Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have had major depression since middle school and everything I have tried. I would be so happy to finally find something that works for me.. it’s really frustrating and hard when you want to be better… but you just can’t… I believe that is happening this election. So be very weary of politicians trying to get you’re you vote.
PatientReceived no prior treatments
~26 spots leftby Apr 2025