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Status unknownNCT05506462Updated Aug 22, 2022

An EEG Study of Intravenous Ketamine for Major Depression Disorder

A Phase 4 interventional study of Ketamine Hydrochloride in Major Depressive Disorder, sponsored by Ehave Inc.. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-22.

Sponsored by Ehave Inc. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

This study will enroll 35 patients with major depressive disorder. Candidates for participation in the study will typically be either referred to the clinic through their healthcare provider or will have sought out participation on their own accord based on advertising. Subjects will be screened for eligibility and suitable patients will be invited to attend a screening visit in the clinic and complete informed consent.

Upon determining eligibility, subjects will have their first treatment session booked within 42 days of screening (Baseline, visit 0). Three subsequent weekly (±3 days) ketamine therapy treatment sessions will occur on days 7, 14 and 21, for a total of four ketamine infusions over four weeks. All patients will return for a follow-up visit at 4-weeks post final treatment visit, day 49.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Intravenous ketamine
  • Electroencephalogram (EEG) monitoring
  • Major depressive disorder
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 35 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

This is the only study on the registry with Ehave Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Ketamine

    50-60 minutes intravenous infusion of 60mg ketamine

    Drug: Ketamine Hydrochloride

Interventions

  • DrugKetamine Hydrochloride

    Patients with a diagnosis of Major Depressive Disorder (MDD) will be enrolled to receive four 50-60 minute infusions of 60mg ketamine hydrochloride

    Also known as: NDC 67457-108-00

06

What researchers measure

Primary outcomes

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

    Alpha, Beta, Delta, Theta and Gamma frequencies will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution

    Time frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)

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

    Alpha, Beta, Delta, Theta and Gamma waveforms will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution

    Time frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)

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

    Alpha, Beta, Delta, Theta and Gamma amplitude will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution

    Time frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)

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

    Alpha, Beta, Delta, Theta and Gamma reading patterns will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution

    Time frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)

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

    Alpha, Beta, Delta, Theta and Gamma frequencies will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution

    Time frame: Pre-treatment baseline, 4 weeks post-treatment course

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

    Alpha, Beta, Delta, Theta and Gamma waveforms will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution

    Time frame: Pre-treatment baseline, 4 weeks post-treatment course

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

    Alpha, Beta, Delta, Theta and Gamma amplitude will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution

    Time frame: Pre-treatment baseline, 4 weeks post-treatment course

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

    Alpha, Beta, Delta, Theta and Gamma amplitude will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution

    Time frame: Pre-treatment baseline, 4 weeks post-treatment course

Secondary outcomes

  1. Incidence of medically significant changes in blood pressure during ketamine infusion

    Time frame: Pre-treatment baseline; treatment initiation, 0 minutes; 20 minutes, 40 minutes; 60 minutes post-infusion

  2. Incidence of medically significant changes in Oxygen Saturation (SpO2) during ketamine infusion

    Time frame: Pre-treatment baseline; treatment initiation, 0 minutes; 20 minutes, 40 minutes; 60 minutes post-infusion

  3. Incidence of medically significant changes in heart rate during ketamine infusion

    Time frame: Pre-treatment baseline; treatment initiation, 0 minutes; 20 minutes, 40 minutes; 60 minutes post-infusion

  4. Incidence of medically significant changes in respiratory rate during ketamine infusion

    Time frame: Pre-treatment baseline; treatment initiation, 0 minutes; 20 minutes, 40 minutes; 60 minutes post-infusion

  5. Changes from baseline in the Dissociative Experiences Scale (DES) Total Score

    The Dissociative Experiences Scale (DES) is a 28-item scale assessing the subject's experiences in his/her daily life. The subject determines to what degree he/she has been facing the situation by selecting a percentage from 0% (never) to 100% (always), with 10% increments in between. Higher scores mean higher severity

    Time frame: Baseline (Day 0), follow-up visit (Day 42)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05506462
Lead sponsor
Ehave Inc.
Collaborators
Tristar Wellness
Responsible party
Sponsor
First posted
Aug 18, 2022
Start date
Jan 2023 (estimated)
Primary completion
Jan 2024 (estimated)
Completion
Feb 2024 (estimated)
Last update
Aug 22, 2022

Study contacts

Jeffrey D Kamlet, MD
Contact
jeffrey@tristarwell.com
305 604 9595
Jeffrey D Kamlet, MD
principal investigator · Tristar Wellness

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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