Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06012916
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2023-07-14
Brief Title:
Brain Network Dynamics of Depression During Esketamine Treatment
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Brain Network Dynamics of Depression During Esketamine Treatment
Status:
COMPLETED
Status Verified Date:
2024-09
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:
K-BRAINED
Brief Summary:
This is a monocentric observational clinical trial investigating the effect of Esketamine on brain network activity and a belief updating task in people with depression We investigate the immediate and the long-term effect approx 8 weeks of Esketamine on EEG signals pupillometry and belief updating and the relation of those effects on depressive symptomatology
Detailed Description:
The FDA approved the S-enantiomer of Ketamine in a nasal spray formulation Esketamine Spravato in 2019 for treatment resistant depression in conjunction with an oral antidepressant Albeit showing impressive short term clinical effects the neurophysiological mechanism leading to clinical improvements are not understood The investigators aim to add missing knowledge about the network dynamics of Esketamine in depression Besides changes of neural signatures Esketamine might impact cognitive processes like belief updating
Previous studies have shown that people update their expectations of future life events after receiving novel information The Belief Updating Task BUT measures this belief update in reaction to new information Healthy individuals have been shown to update their beliefs optimistically making larger changes in their expectations in response to good news Individuals with depression lack this optimistic belief update bias Therefore the investigators also aim to examine if Esketamine treatment reinstates the optimistic bias how those changes are mediated by neurophysiological changes during the task and if a change in belief updated is related to a change of depressive symptoms
The first session takes place at the start of the Esketamine treatment period whereas the second experimental session is conducted closer to the end of the treatment period In both experimental sessions EEGpupillometry and cognitive measurements are taken before and after Esketamine administration Analyses will assess prepost Esketamine effects within a session and between two sessions
Previous studies have shown that people update their expectations of future life events after receiving novel information The Belief Updating Task BUT measures this belief update in reaction to new information Healthy individuals have been shown to update their beliefs optimistically making larger changes in their expectations in response to good news Individuals with depression lack this optimistic belief update bias Therefore the investigators also aim to examine if Esketamine treatment reinstates the optimistic bias how those changes are mediated by neurophysiological changes during the task and if a change in belief updated is related to a change of depressive symptoms
The first session takes place at the start of the Esketamine treatment period whereas the second experimental session is conducted closer to the end of the treatment period In both experimental sessions EEGpupillometry and cognitive measurements are taken before and after Esketamine administration Analyses will assess prepost Esketamine effects within a session and between two sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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