Ketamine for Veterans With Parkinson’s Disease (KPD)

This double-masked, active placebo-controlled, single-dose randomised trial (n=80) will investigate the effects of intravenous (IV) ketamine versus remimazolam for depression in Veterans with Parkinson’s disease (PD).

Led by the VA Office of Research and Development, this study aims to determine if ketamine can alleviate depressive symptoms within 24 hours, and assess its impact on neuroplasticity and inflammation in PD patients.

Participants, aged between 40 to 80 years, must have neurologist-diagnosed idiopathic PD for at least six months, and a history of inadequate response to at least one trial of antidepressant medication. They should be on a stable regimen of all medications for at least two months prior to enrollment.

The primary outcome measure is the Montgomery-Asberg Depression Rating Scale (MADRS), assessing changes in depression severity within 24 hours post-infusion. Secondary measures include various scales for depression, anxiety, quality of life, and adverse events.

The study is expected to start on July 1, 2024, with a primary completion date set for June 30, 2029.

Topic Neurocognitive Disorders Depression Anxiety
Compound Ketamine Placebo
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 July 2024
End date 30 June 2029
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 80
Sex All
Age 40- 80
Therapy No

Trial 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.

Trial Number NCT06231563

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.