Ketamine for Depression in Parkinson's Disease

(KPD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ellen R Bradley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: VA Office of Research and Development

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ellen R Bradley, MD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Eligibility Criteria

This trial is for Veterans with Parkinson's Disease who are experiencing depression. It aims to test if ketamine, known for its rapid antidepressant effects, can improve their condition and quality of life.

Inclusion Criteria

Commit to attend all in-person and remote study visits and participate in all data collection procedures

Is a United States Veteran

I can understand and provide written consent.

Exclusion Criteria

I have an autoimmune or cancer-related disorder.

I've been on a stable dose of medication for inflammation for at least 2 months.

I am not taking medications that increase seizure risk, or I can stop them before the trial.

Treatment Details

Interventions

• Ketamine (NMDA Receptor Antagonist)

Trial Overview The study is testing the effectiveness of intravenous (IV) ketamine compared to a placebo in treating depression in Veterans with Parkinson's Disease. It will also explore how ketamine may affect brain adaptability and inflammation.

Participant Groups

Group I: Ketamine Experimental Treatment 1 Intervention

intravenous ketamine infusion 0.5 mg/kg

Group II: Remimazolam Placebo Group 1 Intervention

intravenous remimazolam infusion 0.25 mg/kg

Ketamine is already approved in Canada for the following indications:

Approved in Canada as Spravato for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine