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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)

Must not have

Mobility limiting osteoarthritis of any lower extremity joints, symptomatic lumbar spine disease, or history of joint replacement / spine surgery that limits mobility

Diagnosis of HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after week 3, and after week 6

Summary

This trial tests L-DOPA, a medication that increases dopamine levels in the brain. It targets elderly individuals with depression who have issues with motivation, thinking speed, and movement. By boosting dopamine, the treatment aims to improve mood, cognitive function, and mobility. L-DOPA is used to treat the motor symptoms associated with Parkinson's disease by increasing dopamine levels in the brain.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe joint pain or back issues that limit my ability to move.

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I have been diagnosed with HIV.

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I have a primary neurological disorder such as dementia, stroke, Parkinson's, or epilepsy.

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I have a disability that makes it hard for me to complete health assessments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after week 3, and after week 6

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Effort Expenditure for Rewards Task (EEfRT)

Change in Gait pattern

Change in Letter Comparison Test Score

+3 more

Secondary study objectives

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

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

L-Dopa

2011

Completed Phase 3

~30

Placebo

1995

Completed Phase 3

~2670