Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480201
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-19
Brief Title:
Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The core objective of this study is to enhance the translational potential of this electroencephalogram EEG biomarker by using ketamineKET-induced gamma potentiation as a prognostic marker of 4-week treatment outcome Previous research focused exclusively on KET-induced gamma band potentiation GBP in the context of a single infusion Our study design captures the clinical variation associated with real-world treatment resistant depression TRD patients and allows us to analyze the relative importance of GBP to antidepressant symptom reduction across the induction phase of treatment If successful it provides a compelling rationale for a larger prospective investigation of gamma dynamics as a moderator of outcome to varied TRD therapies which impact the balance of cortical excitation and inhibition
Detailed Description:
Treatment-resistant depression TRD is a significant public health issue and the leading cause of disability in young and middle-aged adults Treatment of depression via the rapid acting modulation of neural circuitry is at a critical stage of development with strategies such as ketamine KET infusion esketamine nasal spray and intermittent theta burst stimulation making substantial progress Determining the prognosis for an intervention however remains a challenge due to the lack of a central biomarker to indicate the potential receptiveness of the target system glutamate to modulation KET biomarker research has strong translational potential as a platform to enhance prognostic prediction of neuromodulatory therapeutics more broadly
Electroencephalography EEG gamma band power is a neurophysiological measure of cortical excitability and synaptic potentiation These processes are implicated in KETs mechanism as a N-methyl-D-aspartate NMDA receptor channel antagonist making gamma power a candidate biomarker In patients with TRD the interaction between pre- and post-ketamine EEG gamma band amplitude 30 Hz has been identified as a biomarker for the optimal state of excitationinhibition EI balance required to achieve an antidepressant response from ketamine
Theoretically the process of gamma band potentiation GBP by ketamine represents the capacity of the brain to up-regulate glutamatergic activity in response to the initial infusion In the context of the broader mechanism of action for ketamine treatment of depression GBP is likely tied to the integrity of downstream effects of ketamine These processes regulate longer term patterns of cellular learning such as synaptic long-term potentiation and therefore the efficiency with which they can be activated is a critical metric for understanding how likely patients will be to enter remission
The core objective of this study is to enhance the translational potential of this EEG biomarker by using KET-induced gamma potentiation as a prognostic marker of 4-week treatment outcome Previous research focused exclusively on KET-induced GBP in the context of a single infusion Our study design captures the clinical variation associated with real-world TRD patients and allows us to analyze the relative importance of GBP to antidepressant symptom reduction across the induction phase of treatment If successful it provides a compelling rationale for a larger prospective investigation of gamma dynamics as a moderator of outcome to varied TRD therapies which impact the balance of cortical excitation and inhibition
Electroencephalography EEG gamma band power is a neurophysiological measure of cortical excitability and synaptic potentiation These processes are implicated in KETs mechanism as a N-methyl-D-aspartate NMDA receptor channel antagonist making gamma power a candidate biomarker In patients with TRD the interaction between pre- and post-ketamine EEG gamma band amplitude 30 Hz has been identified as a biomarker for the optimal state of excitationinhibition EI balance required to achieve an antidepressant response from ketamine
Theoretically the process of gamma band potentiation GBP by ketamine represents the capacity of the brain to up-regulate glutamatergic activity in response to the initial infusion In the context of the broader mechanism of action for ketamine treatment of depression GBP is likely tied to the integrity of downstream effects of ketamine These processes regulate longer term patterns of cellular learning such as synaptic long-term potentiation and therefore the efficiency with which they can be activated is a critical metric for understanding how likely patients will be to enter remission
The core objective of this study is to enhance the translational potential of this EEG biomarker by using KET-induced gamma potentiation as a prognostic marker of 4-week treatment outcome Previous research focused exclusively on KET-induced GBP in the context of a single infusion Our study design captures the clinical variation associated with real-world TRD patients and allows us to analyze the relative importance of GBP to antidepressant symptom reduction across the induction phase of treatment If successful it provides a compelling rationale for a larger prospective investigation of gamma dynamics as a moderator of outcome to varied TRD therapies which impact the balance of cortical excitation and inhibition
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?:
None
Is an FDA AA801 Violation?:
None