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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 : Recruiting
First Posted : October 27, 2021
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Entheon Biomedical Corp.

Tracking Information
First Submitted Date October 5, 2021
First Posted Date October 27, 2021
Last Update Posted Date November 10, 2021
Actual Study Start Date November 9, 2021
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2021)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 15, 2021)
  • Genetic markers on neurological phenotypes [ Time Frame: Baseline ]
    Correlation of neurological phenotypes with genetic markers
  • CADSS-6 correlation with neurological phenotypes [ Time Frame: Up to 67 days ]
    Correlation of neurological phenotypes of Clinician Administered Dissociative Symptom Scale (CADSS-6).
  • 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)
  • PMQ-SF correlation with neurological phenotypes [ Time Frame: Up to 67 days ]
    Correlation of neurological phenotypes Psychedelic Music Questionnaire Short Form (PMQ-SF)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)
Official Title Evaluation of the Effect of Ketamine on Neurological Activity as Measured by Quantitative EEG
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Treatment-resistant Depression
Intervention Other: Observational - no intervention
This is an observational study with no intervention.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 15, 2021)
36
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kim McDonald-Taylor, MSc 6472672942 Kmcdonald-taylor@rogers.com
Contact: Andrew Hegle, PhD 6047155958 andrew@entheonbiomedical.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05095792
Other Study ID Numbers EBIQ-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Entheon Biomedical Corp.
Study Sponsor Entheon Biomedical Corp.
Collaborators Not Provided
Investigators
Principal Investigator: Steven Levine, MD Heading Health
PRS Account Entheon Biomedical Corp.
Verification Date November 2021