Actively Recruiting
Ketamine for Veterans With Parkinson's Disease
Led by VA Office of Research and Development · Updated on 2026-04-13
80
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ketamine for Veterans With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide written informed consent
- Is a United States Veteran
- Between 40-80 years old at the time of informed consent
- Have neurologist-diagnosed idiopathic Parkinson's disease (PD) for at least six months prior to enrollment
- History of inadequate response to at least one trial of antidepressant medication
- On a stable regimen of all medications for at least 2 months prior to enrollment and have no planned medication changes during the period of active participation
- Commit to attend all in-person and remote study visits and participate in all data collection procedures
- Have a score /=20 on the Montgomery-Asberg Depression Rating Scale (MADRS), consistent with moderate or greater depressive symptom severity, at Baseline
- If already engaged in psychotherapy or other non-pharmacologic treatments for depression, agree to maintain consistent engagement throughout the period of active study participation
- If not engaged in psychotherapy or other non-pharmacologic treatments for depression, agree to avoid starting a new course of treatment for the period of active study participation
- Agree to abstain from cannabis for a minimum of 72 hours prior to assessments on Day - 1 and to remain abstinent through assessments on Day 0
- If a regular user of tobacco or nicotine, agree to maintain a consistent pattern of use throughout the period of active study participation; if an infrequent/occasional user, agree to abstain throughout the period of active study participation
- For people who can become pregnant or trying to conceive: agree to use highly effective contraception from entry into the trial through Day 7 assessments
You will not qualify if you...
- Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, or current psychosis with loss of insight
- Dementia or cognitive impairment as determined by a MoCA (telephone version) score <18 at screening
- Moderate or severe substance use disorder during the 6 months prior to enrollment or a breathalyzer test showing an alcohol level > 0% at screening or a positive urine toxicology panel at screening, except cannabis as noted in inclusion criteria
- Pregnancy, breastfeeding, or plans to become pregnant during the trial period
- Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) treatment within 30 days prior to enrollment or plans to begin either therapy during participation
- High risk of self-harm/suicide warranting immediate treatment as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) at screening
- Current severe depression symptoms preventing ability to provide for basic needs or safety at screening
- Meeting safety exclusion criteria for TMS (seizure disorder, ferrous metal or implanted devices above the chest, history of severe traumatic brain injury, tinnitus)
- Meeting safety exclusion criteria for ketamine treatment (previous hypersensitivity to ketamine, hepatitis or liver failure, cystitis, or cardiovascular conditions increasing risk with blood pressure rises)
- Use of medications that interfere with ketamine or increase adverse event risk if abstinence not feasible for at least 5 half-lives before Day -1 through Day 0 assessments
- Use of medications impacting motor cortex plasticity if abstinence not feasible for at least 5 half-lives before Day -1 through Day 0 assessments
- Use of medications increasing risk with TMS if abstinence not feasible for at least 5 half-lives before Day -1 through Day 0 assessments
- Autoimmune or neoplastic disorders
- Use of cytokine antagonists or other inflammation-modulating medications unless stable for at least 2 months with no planned changes during trial
- Other medical conditions or abnormalities posing safety concerns for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563
Actively Recruiting
Research Team
E
Ellen R Bradley, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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