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

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ClinicalTrials.gov Identifier: NCT05095792
Recruitment Status : Completed
First Posted : October 27, 2021
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
Entheon Biomedical Corp.

Study Description
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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).

Condition or disease Intervention/treatment
Treatment-resistant Depression Other: Observational - no intervention

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 Design
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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Effect of Ketamine on Neurological Activity as Measured by Quantitative EEG
Actual Study Start Date : November 9, 2021
Actual Primary Completion Date : October 21, 2022
Actual Study Completion Date : October 21, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Observational - no intervention
    This is an observational study with no intervention.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Genetic markers on neurological phenotypes [ Time Frame: Baseline ]
    Correlation of neurological phenotypes with genetic markers

  2. CADSS-6 correlation with neurological phenotypes [ Time Frame: Up to 67 days ]
    Correlation of neurological phenotypes of Clinician Administered Dissociative Symptom Scale (CADSS-6).

  3. 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)

  4. PMQ-SF correlation with neurological phenotypes [ Time Frame: Up to 67 days ]
    Correlation of neurological phenotypes Psychedelic Music Questionnaire Short Form (PMQ-SF)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05095792


Locations
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United States, Texas
Heading Health
Austin, Texas, United States, 78746
Sponsors and Collaborators
Entheon Biomedical Corp.
Investigators
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Principal Investigator: Steven Levine, MD Heading Health
More Information
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Responsible Party: Entheon Biomedical Corp.
ClinicalTrials.gov Identifier: NCT05095792    
Other Study ID Numbers: EBIQ-101
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder, Treatment-Resistant
Depressive Disorder
Mood Disorders
Mental Disorders