Ketamine for Veterans With Parkinson's Disease (NCT06231563) | Clinical Trial Compass
RecruitingPhase 2
Ketamine for Veterans With Parkinson's Disease
United States80 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Lifetime history of schizophrenia or schizoaffective disorder or 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. Note that a positive result for cannabis is an exception; see Inclusion Criteria
✕. Pregnancy, breastfeeding, or plans to become pregnant during the period of trial participation.
✕. Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) treatment within 30 days prior to enrollment or plans to begin either therapy during the participation period
✕. High risk of self-harm/suicide that warrants immediate treatment as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening
✕. Current severity of depression symptoms warranting immediate treatment (i.e., resulting in inability to provide for basic needs/safety) at screening
✕. Meeting standard safety exclusion criteria for TMS (seizure disorder, ferrous metal or implanted devices above the chest, history of severe traumatic brain injury, tinnitus)