Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04504175
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2020-07-30
Brief Title:
Ketamine for Older Adults Pilot
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Precision Medicine With Ketamine for Older Adults With Treatment-resistant Depression Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-02
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:
None
Brief Summary:
This pilot study will assess the safety and feasibility of intravenous IV ketamine in older adults with Treatment-Resistant Depression TRD In addition this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine and mobile health approaches in depression treatment
Detailed Description:
Participants in this study will receive ketamine infusions twice a week for 4 weeks acute phase Participants who respond or remit will continue with an additional 4 weeks of weekly ketamine infusions continuation phase Participants will be assessed at baseline end of acute phase and end of continuation phase for effectiveness safety and executive functioning Participants will be asked to complete daily surveys of their depression symptoms during their participation
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?:
False
Is an FDA AA801 Violation?:
None