Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620042
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
FMRI of Patients Receiving IV Ketamine for Treatment Resistant Bipolar Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Functional Magnetic Resonance Imaging of Patients Receiving Intravenous Ketamine for Treatment Resistant Bipolar Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective open-label observational study of patients with treatment resistant bipolar depression referred for intravenous ketamine with an interventional component of fMRI
Detailed Description:
This is a prospective open-label observational study of patients with treatment resistant bipolar depression referred for intravenous ketamine All participants will receive an acute series of ketamine consisting of twice weekly infusions over three weeks Non-responders will have their End of Study visits within 5 days of the last ketamine infusion Responders participants who achieve a greater than or equal to 50 decrease on their QIDS-SR-16 score from Baseline will return for three weeks of continuation treatment weekly ketamine and then have their End of Study visit within 5 days of the last continuation treatment All participants will undergo fMRI the prior to their first ketamine infusion and after completion of their acute series
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None