Ketamine for Veterans With Parkinson's Disease

Part of paid clinical trials in San Francisco, California.

Sponsor
VA Office of Research and Development
Study ID
NCT06231563
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine — DRUG
    intravenous ketamine infusion 0.5 mg/kg
  • Remimazolam — DRUG
    intravenous remimazolam infusion 0.03 mg/kg

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ketamine
    intravenous ketamine infusion 0.5 mg/kg
  • Placebo Comparator: Remimazolam
    intravenous remimazolam infusion 0.03 mg/kg

Primary Outcome Measure

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline and 24 hours post-infusion. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical Center, San Francisco, CASan FranciscoCalifornia94121-1563
Anusha Badathala, MD
[email protected]
415-688-1923
Rebecca Yu
[email protected]
(415) 221-4810
Ellen R Bradley, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
San Francisco VA Medical Center, San Francisco, CA· San Francisco, CA

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