Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-27 @ 6:47 AM
Study NCT ID:
NCT05095792
Status:
TERMINATED
Last Update Posted:
2024-11-14
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)
Sponsor:
Entheon Biomedical Corp.
Organization:
Study Overview
Official Title:
Evaluation of the Effect of Ketamine on Neurological Activity as Measured by Quantitative EEG
Status:
TERMINATED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision to stop enrollment after 1 participant completed the study. Will not be reopening.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study will allow data to be collected to demonstrate changes in brain activity following administration of standard of care (SOC) Ketamine. By comparing genetic markers across participants, data on impact of genetic markers and response to Ketamine will also be analysed. This data will contribute to the design of future studies utilizing Ketamine for various psychiatric disorders. This study will focus on treatment-resistant Major Depressive Disorder (MDD).
Detailed Description:
This is an Open Label Observational Study with the primary objective to assess brain activity in patients prior to, during and after Ketamine treatment and to assess genetic markers prior to Ketamine treatment. This is a non-interventional study that will observe the Electroencephalogram (EEG) pattern of participants who, per standard of care, are treated with intramuscular Ketamine. The administration of the Ketamine during this study is not considered investigational. The experimental intervention, measurements via EEG, will be offered to patients of the study site presenting for intramuscular (IM) ketamine treatment per the site's established and evidence-based protocol as part of their regular clinical care. Participants in this study have already been determined to have a medically appropriate indication for IM Ketamine treatment, independent of enrollment in this study. Given the requirement, per study protocol, to wear an EEG headset and complete study measures, participants will be compensated by having treatment costs paid by the study sponsor. There will be 36 participants enrolled at one study site.
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?: