Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)

Treatment-resistant Depression Clinical Trial

Official title:

Evaluation of the Effect of Ketamine on Neurological Activity as Measured by Quantitative EEG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095792
• Other study ID #: EBIQ-101
• Status: Completed
• Start date: November 9, 2021
• Est. completion date: October 21, 2022

Study information

• Verified date: November 2022
• Source: Entheon Biomedical Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 21, 2022
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 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)

2. All genders aged 21 to 60 years of age

3. Prescribed Ketamine or currently being treated with Ketamine for treatment-resistant Major Depressive Disorder

4. Willing to wear an Electroencephalogram (EEG) headset and an eye mask

5. Willing to listen to ambient sound

6. Willing to have a genetic cheek swab

Exclusion Criteria:

1. Pregnancy

2. Traumatic Brain Injury within past 3 months

3. Body weight < 50 kg or > 120 kg

4. Coronary heart disease

5. Uncontrolled hypertension as defined in the American College of Cardiology/American Heart Association (ACC/AHA) Hypertension Guidelines

6. Previous contact with Ketamine (therapeutically or recreationally) outside of treatment at the study site

7. Primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder)

8. Bipolar disorder with current manic, hypomanic or mixed state

9. Post-traumatic stress disorder

10. Obsessive-compulsive disorder

11. Primary substance-use disorder

12. Alcohol consumption 24 hours prior and 48 hours subsequent to treatment

13. 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

Related Conditions & MeSH terms

• Depressive Disorder, Treatment-Resistant
• Treatment-resistant Depression

Intervention

Other:
• Observational - no intervention
This is an observational study with no intervention.

Locations

Country	Name	City	State
United States	Heading Health	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Entheon Biomedical Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter and intra patient variability in neurological activity.	Observation of the the inter and intra patient variability in neurological activity.	Up to 74 days
Secondary	Genetic markers on neurological phenotypes	Correlation of neurological phenotypes with genetic markers	Baseline
Secondary	CADSS-6 correlation with neurological phenotypes	Correlation of neurological phenotypes of Clinician Administered Dissociative Symptom Scale (CADSS-6).	Up to 67 days
Secondary	QIDS SR-16 correlation with neurological phenotypes	Correlation of neurological phenotypes of depressed patients with Quick Inventory of Depressive Symptomatology (QIDS SR-16)	Up to 67 days
Secondary	PMQ-SF correlation with neurological phenotypes	Correlation of neurological phenotypes Psychedelic Music Questionnaire Short Form (PMQ-SF)	Up to 67 days