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TerminatedN/A

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

NCT05095792 · Entheon Biomedical Corp.

Closed to entry
Status
Not accepting participants
Not applicable
Phase
1
Target enrolment
1
Study sites
1 US states

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Inter and intra patient variability in neurological activity.

    Measured over Up to 74 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 60 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Heading HealthAustinTexasUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05095792 on ClinicalTrials.gov →

Last updated in the registry 2024-11-14. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in