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Can a Parkinson's drug boost brain function in depressed seniors?

NCT ID NCT04469959

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This study tested whether levodopa, a drug used for Parkinson's disease, can improve thinking speed, walking, and mood in older adults with depression. Researchers gave 79 participants either levodopa or a placebo for three weeks. The goal was to see if boosting dopamine could help with the mental and physical slowing often seen in late-life depression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Levodopa (carbidopa/levodopa, also known as Sinemet)
What this could lead to
If it works, this could point toward a treatment that improves thinking speed and mobility in older adults with depression.
What could go wrong
This is a small, early-phase trial with only 79 participants. The treatment is short-term, and benefits may not last or apply to everyone. Levodopa can cause side effects like nausea or dizziness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

79 people

The number who actually took part.

Started

Feb 2021

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 60 years 2. Diagnostic and Statistical Manual-5 (DSM5) diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depression Not Otherwise Specified (NOS) 3. MADRS score ≥ 15 4. Decreased processing speed (0.5 SD below age-adjusted norms on the WAIS-IV Coding task or Trail Making Test, Part A) or decreased motor speed (gait speed/average walking speed on 15' course ≤ 1m/s, or 0.5 SD below age-, gender- and education-adjusted norms on the grooved pegboard test) 5. Capable of providing informed consent and adhering to study procedures Exclusion Criteria: 1. Diagnosis of substance abuse or dependence (excluding Tobacco Use Disorder) in the past 12 months 2. Other psychiatric disorders including a history of psychosis, psychotic disorder, mania, or bipolar disorder. Other comorbid psychiatric disorders are allowable if the depressive disorder diagnosis is considered to be the primary problem 3. Primary neurological disorder, including dementia, stroke, Parkinson's disease, epilepsy, etc 4. SBT \> 10 5. MADRS suicide item \> 4 or other indication of acute suicidality 6. History of inpatient psychiatric hospitalization in the last year; 7. History of suicidal ideation in the last 6 months, operationalized as a 'yes' response to item 4 or 5 in the "Suicidal Ideation" section of the Columbia-Suicide Severity Rating Scale (CSSRS) 8. Any suicidal behavior in the last year (operationalized as a 'yes' response to any item in the "Suicidal Behavior" section of the CSSRS, including actual interrupted, aborted, or preparatory acts) 9. Current or recent (within the past 2 weeks) treatment with antipsychotics or mood stabilizers, or use of antidepressants where washout is not advisable 10. History of hypersensitivity, allergy, or intolerance to Carbidopa/levodopa 11. Any physical or intellectual disability adversely affecting ability to complete assessments 12. Unstable medical illness 13. Mobility limiting osteoarthritis of any lower extremity joints, symptomatic lumbar spine disease, or history of joint replacement / spine surgery that limits mobility 14. Diagnosis of HIV 15. History of significant radioactivity exposure (nuclear medicine studies or occupational exposure).

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction depressive disorder Depressive Disorder, Treatment-Resistant dysthymic disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • Vanderbilt Psychiatric Hospital

    Nashville, Tennessee, 37212, United States

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