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Unknown statusPhase 4

An EEG Study of Intravenous Ketamine for Major Depression Disorder

NCT05506462 · Ehave Inc.

Closed to entry
Status
Not accepting participants
Phase 4
Phase
35
Target enrolment
Study sites

What it is testing

Summary

There are many common pharmacological treatments for major depression disorder (MDD), however the efficacy of these drugs often fails in severe cases. Intravenous (IV) administered ketamine may offer the potential for remission of the symptoms in patients with MDD; however it has not yet been approved by FDA for this purpose. This study will make use of an electroencephalography (EEG) machine to measure the brain's activity and response while the IV ketamine is being delivered. The objective of this study is to characterize the change in EEG response of patients with MDD, during and 4 weeks after a course of IV ketamine infusions.

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

  • Characterizing the changes in EEG reading frequencies from pre- IV ketamine infusion treatment (baseline).

    Measured over 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)

  • Characterizing the changes in EEG reading waveforms from pre- IV ketamine infusion treatment (baseline).

    Measured over 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)

  • Characterizing the changes in EEG reading amplitudes from pre- IV ketamine infusion treatment (baseline).

    Measured over 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)

  • Characterizing the changes in EEG reading patterns from pre- IV ketamine infusion treatment (baseline).

    Measured over 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)

  • Characterizing the changes in EEG reading frequencies from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course

    Measured over Pre-treatment baseline, 4 weeks post-treatment course

  • Characterizing the changes in EEG reading waveforms from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course

    Measured over Pre-treatment baseline, 4 weeks post-treatment course

  • Characterizing the changes in EEG reading amplitudes from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course

    Measured over Pre-treatment baseline, 4 weeks post-treatment course

  • Characterizing the changes in EEG reading patterns from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course

    Measured over Pre-treatment baseline, 4 weeks post-treatment course

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

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Individuals between 18 and 70 years of age, inclusive 2. Adult patients with a documented primary Axis I clinical diagnosis meeting criteria from the DSM-V for a major depressive disorder 3. Score of \<15 on the DES 4. Moderate to severe symptoms objectively documented using MADRS total score of ≥ 20 5. Ability to maintain scheduled appointments for screenings, 4 treatment visits and follow-up EEG visit. 6. History of major depressive disorder. 7. Females of child-bearing potential who are sexually active must agree to use two forms of contraception. A pregnancy test will be performed before the first treatment. 8. Must have stable residence address, internet and mobile phone. 9. Must speak fluent English. Exclusion Criteria: 1. Known allergy to ketamine or any other drug used in the study. 2. Use of ketamine in a therapeutic model within the preceding 12 months of the study. 3. Current or any history of schizoaffective disorder(s). 4. Score of ≥ 15 on DES 5. History of illicit active substance abuse or dependence including ketamine as determined on by the SCID-5-CT and/or drug urine screening during study visits. 6. Pregnancy, breastfeeding or desire to become pregnant during the course of the study. 7. Serious, unstable illnesses including, but not limited to; hepatic, gastro-intestinal, respiratory, cardiovascular (including ischemic heart disease and coronary heart disease). History of ischemic stroke, atrial fibrillation, severe endocrinological, neurological, immunological or hematological disease. 8. Any history of cerebral vascular events including stroke, bleeding into the brain and subdural hematomas. 9. Any implantable metallic device(s) or implant(s) above the level of shoulders. 10. Any non-removable metallic piercings. 11. Patients with cochlear implants and non-removable hearing aids. 12. Current use of: Dilantin, Depakote, Phenobarbital, Gabapentin, Pregabalin and Benzodiazepines. Certain candidates with long use of Benzodiazepines may qualify at PI's discretion. 13. Severe labile hypertension. 14. Significant uncontrolled hypertension (i.e., SBP \> 150 mmHG, DBP \> 100 mmHG) 15. Uncontrolled diabetes mellitus. 16. Patients on renal dialysis. 17. Inability to achieve consistent IV access.

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.

NCT05506462 on ClinicalTrials.gov →

Last updated in the registry 2022-08-22. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits