Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06231563
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-09
Brief Title:
Ketamine for Veterans With Parkinsons Disease
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Examining Ketamine Effects on Depression Neuroplasticity and Inflammation in Veterans With Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KPD
Brief Summary:
Parkinsons 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 brains 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 ketamines 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
Detailed Description:
This is a double-masked active placebo-controlled single dose randomized trial of intravenous IV ketamine versus remimazolam for depression in Veterans N80 with Parkinsons disease PD The investigators hypothesize that ketamine will have a strong safety and tolerability profile and improve depressive symptoms within 24 hours Aim 1 Further its antidepressant effects will be associated with modulation of both impaired neuroplasticity Aim 2 and elevated inflammatory activity Aim 3 To test these hypotheses the investigators will use clinical assessments of adverse events tolerability and depression non-invasive brain stimulation techniques to quantify changes in LTP-like neuroplasticity and blood-based cytokine measurement to quantify changes in systemic inflammation This study will provide clinical efficacy data and elucidate ketamines mechanisms of action in PD using accessible neuroscience-informed markers of neuroplasticity and inflammation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23-40158 | OTHER | None | None |
| CX002606 | OTHER_GRANT | Department of Veterans Affairs | None |