Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-27 @ 10:28 PM
Study NCT ID:
NCT04928703
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2021-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers
Sponsor:
ERP Biomarker Qualification Consortium
Organization:
Study Overview
Official Title:
A Phase 0, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Assess Ketamine-induced Changes in ERP Biomarkers in Healthy Volunteers
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 is a Phase 0, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to assess the changes in ERP Biomarkers in Healthy Volunteers before and after administration of a sub-anesthetic dose of ketamine. Primary objectives are to quantify the effect size of ketamine-induced changes on MMN from a duration-deviant auditory oddball ERP test and to quantify the variability of ketamine-induced changes on MMN from a duration-deviant auditory oddball ERP test.
Detailed Description:
The effects of ketamine and similar compounds on brain function have become of significant interest to pharma companies in the past few years. These effects are often used as a model for the glutamatergic hypofunction hypothesis of schizophrenia and therefore drugs targeting schizophrenia are being trialed to reverse or block the effects of ketamine. Esketamine has been recently approved as a potent treatment for depression so many pharma companies are trying to leverage ketamine-like modulation of the NMDA receptors as novel targets for depression.
This heightened focus on NMDAr modulators has lead industry and academia to advance methods to measure these effects. Many studies have been performed using EEG and ERP techniques to measure the effect on brain function of ketamine administration but no study has been performed, to our knowledge, that has attempted to measure the variability and reproducibility of these effects. Furthermore, there is some evidence from the scientific literature and from unpublished results from industry-sponsored studies that ketamine may have a disordinal effect on various electrophysiologic measures, particularly the amplitude of the mismatch negativity (MMN) from an auditory oddball ERP test.
In this study we will run various EEG/ERP tests on participants during a placebo administration and during two ketamine administrations separated by washout periods. This will allow, for the first time, the evaluation of the test-retest variability of a range ERP/EEG measures under ketamine administration vs placebo. This may also allow us to test the hypothesis that ketamine has a disordinal effect on different subjects and this disordinality can be predicted from a baseline (placebo) measurement.
This heightened focus on NMDAr modulators has lead industry and academia to advance methods to measure these effects. Many studies have been performed using EEG and ERP techniques to measure the effect on brain function of ketamine administration but no study has been performed, to our knowledge, that has attempted to measure the variability and reproducibility of these effects. Furthermore, there is some evidence from the scientific literature and from unpublished results from industry-sponsored studies that ketamine may have a disordinal effect on various electrophysiologic measures, particularly the amplitude of the mismatch negativity (MMN) from an auditory oddball ERP test.
In this study we will run various EEG/ERP tests on participants during a placebo administration and during two ketamine administrations separated by washout periods. This will allow, for the first time, the evaluation of the test-retest variability of a range ERP/EEG measures under ketamine administration vs placebo. This may also allow us to test the hypothesis that ketamine has a disordinal effect on different subjects and this disordinality can be predicted from a baseline (placebo) measurement.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: