- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05095792
Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)
November 4, 2022 updated by: Entheon Biomedical Corp.
Evaluation of the Effect of Ketamine on Neurological Activity as Measured by Quantitative EEG
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78746
- Heading Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Male or female participants with treatment-resistant Major Depressive Disorder aged 21-60 interested in receiving intra-muscular injections of ketamine over 10 sessions in the clinic and willing to wear an electroencephalogram (EEG) headset to measure their brain wave patterns.
Description
Inclusion Criteria:
Primary Diagnostic and Statistical Manuel of Mental Disorders 5 (DSM-V) diagnosis of treatment-resistant Major Depressive Disorder (may have secondary diagnoses of general anxiety, substance disorder)
- Non-responders to at least 2 previous anti-depressant medications prescribed by a physician in the past five years
- Score of ≥20 on Montgomery-Asberg Depression Rating Scale (MADRS) (i.e., moderate to severe depression)
- All genders aged 21 to 60 years of age
- Prescribed Ketamine or currently being treated with Ketamine for treatment-resistant Major Depressive Disorder
- Willing to wear an Electroencephalogram (EEG) headset and an eye mask
- Willing to listen to ambient sound
- Willing to have a genetic cheek swab
Exclusion Criteria:
- Pregnancy
- Traumatic Brain Injury within past 3 months
- Body weight < 50 kg or > 120 kg
- Coronary heart disease
- Uncontrolled hypertension as defined in the American College of Cardiology/American Heart Association (ACC/AHA) Hypertension Guidelines
- Previous contact with Ketamine (therapeutically or recreationally) outside of treatment at the study site
- Primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
- Bipolar disorder with current manic, hypomanic or mixed state
- Post-traumatic stress disorder
- Obsessive-compulsive disorder
- Primary substance-use disorder
- Alcohol consumption 24 hours prior and 48 hours subsequent to treatment
Currently using any of the following medications:
- Benzodiazepines for 6 hours prior to treatment and 2 hours after treatment
- Lamotrigine for 6 hours prior to treatment
- Amphetamine-based stimulants for 6 hours prior to treatment
- Monoamine Oxidase Inhibitors (MAO-Is) may be taken but blood pressure must be monitored
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inter and intra patient variability in neurological activity.
Time Frame: Up to 74 days
|
Observation of the the inter and intra patient variability in neurological activity.
|
Up to 74 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genetic markers on neurological phenotypes
Time Frame: Baseline
|
Correlation of neurological phenotypes with genetic markers
|
Baseline
|
CADSS-6 correlation with neurological phenotypes
Time Frame: Up to 67 days
|
Correlation of neurological phenotypes of Clinician Administered Dissociative Symptom Scale (CADSS-6).
|
Up to 67 days
|
QIDS SR-16 correlation with neurological phenotypes
Time Frame: Up to 67 days
|
Correlation of neurological phenotypes of depressed patients with Quick Inventory of Depressive Symptomatology (QIDS SR-16)
|
Up to 67 days
|
PMQ-SF correlation with neurological phenotypes
Time Frame: Up to 67 days
|
Correlation of neurological phenotypes Psychedelic Music Questionnaire Short Form (PMQ-SF)
|
Up to 67 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven Levine, MD, Heading Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 9, 2021
Primary Completion (Actual)
October 21, 2022
Study Completion (Actual)
October 21, 2022
Study Registration Dates
First Submitted
October 5, 2021
First Submitted That Met QC Criteria
October 15, 2021
First Posted (Actual)
October 27, 2021
Study Record Updates
Last Update Posted (Actual)
November 7, 2022
Last Update Submitted That Met QC Criteria
November 4, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBIQ-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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