RecruitingPhase 2NCT06231563

Ketamine for Veterans With Parkinson's Disease

Examining Ketamine Effects on Depression, Neuroplasticity, and Inflammation in Veterans With Parkinson's Disease


Sponsor

VA Office of Research and Development

Enrollment

80 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Parkinson's disease (PD) is a devastating illness that has a growing impact on Veterans. One of the most disabling symptoms is depression, which is common in PD and linked to poor quality of life and higher risk of suicide. Unfortunately, there is a lack of effective treatments for depression in PD. Ketamine, which has rapid and potent antidepressant effects, is a potential option but has not been tested in Veterans with PD. Studies in rodents show that ketamine may not only improve depression in PD, it may target two of the underlying drivers of the disease: (1) reduced neuroplasticity, or the brain's ability to adapt and remodel itself; and (2) elevated inflammation. The investigators are conducting a randomized, placebo-controlled study to examine if a dose of intravenous (IV) ketamine improves depression in Veterans with PD. The investigators will also examine ketamine's effects on neuroplasticity and inflammation, which will help us understand how ketamine works in PD and if it can be a useful treatment for Veterans with the disease. This study will lay groundwork for a larger clinical trial across multiple VA sites.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether low-dose ketamine infusions can help relieve depression in United States military veterans who have Parkinson's disease and have not responded well to standard antidepressant medications. **You may be eligible if...** - You are a U.S. Veteran between 40 and 80 years old - You have been diagnosed with Parkinson's disease by a neurologist for at least 6 months - You have moderate or greater depression symptoms that have not responded adequately to at least one prior antidepressant - Your medications have been stable for at least 2 months and are not expected to change - You are willing and able to attend all in-person and remote study visits **You may NOT be eligible if...** - You are not a U.S. Veteran - Your Parkinson's medications are not yet stable - You have severe depression or are at high risk of suicide requiring immediate intervention - You have other conditions that make ketamine unsafe (such as uncontrolled high blood pressure or certain psychiatric conditions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

intravenous ketamine infusion 0.5 mg/kg

DRUGRemimazolam

intravenous remimazolam infusion 0.03 mg/kg


Locations(1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06231563


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