An EEG Study of Intravenous Ketamine for Major Depression Disorder

• ClinicalTrials.gov Identifier: NCT05506462
• Recruitment Status: Not yet recruiting
• First Posted: August 18, 2022
• Last Update Posted: August 22, 2022
• Sponsor: Ehave Inc.
• Collaborator: Tristar Wellness
• Information provided by (Responsible Party): Ehave Inc.

Tracking Information

• First Submitted Date: August 9, 2022
• First Posted Date: August 18, 2022
• Last Update Posted Date: August 22, 2022
• Estimated Study Start Date: January 2023
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 18, 2022)

• Characterizing the changes in EEG reading frequencies from pre- IV ketamine infusion treatment (baseline). [ Time Frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes) ]
  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
• Characterizing the changes in EEG reading waveforms from pre- IV ketamine infusion treatment (baseline). [ Time Frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes) ]
  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
• Characterizing the changes in EEG reading amplitudes from pre- IV ketamine infusion treatment (baseline). [ Time Frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes) ]
  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
• Characterizing the changes in EEG reading patterns from pre- IV ketamine infusion treatment (baseline). [ Time Frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes) ]
  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
• Characterizing the changes in EEG reading frequencies from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course [ Time Frame: Pre-treatment baseline, 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
• Characterizing the changes in EEG reading waveforms from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course [ Time Frame: Pre-treatment baseline, 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
• Characterizing the changes in EEG reading amplitudes from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course [ Time Frame: Pre-treatment baseline, 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
• Characterizing the changes in EEG reading patterns from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course [ Time Frame: Pre-treatment baseline, 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

Original Primary Outcome Measures (submitted: August 16, 2022)

• Characterizing the changes in EEG reading frequencies from pre- IV ketamine infusion treatment (baseline). [ Time Frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes) ]
  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
• Characterizing the changes in EEG reading waveforms from pre- IV ketamine infusion treatment (baseline). [ Time Frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes) ]
  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
• Characterizing the changes in EEG reading amplitudes from pre- IV ketamine infusion treatment (baseline). [ Time Frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes) ]
  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
• Characterizing the changes in EEG reading patterns from pre- IV ketamine infusion treatment (baseline). [ Time Frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes) ]
  EEG reading patterns will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution
• Characterizing the changes in EEG reading frequencies from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course [ Time Frame: Pre-treatment baseline, 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
• Characterizing the changes in EEG reading waveforms from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course [ Time Frame: Pre-treatment baseline, 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
• Characterizing the changes in EEG reading amplitudes from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course [ Time Frame: Pre-treatment baseline, 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
• Characterizing the changes in EEG reading patterns from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course [ Time Frame: Pre-treatment baseline, 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

Current Secondary Outcome Measures (submitted: August 16, 2022)

• 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 ]
• 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 ]
• 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 ]
• 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 ]
• Changes from baseline in the Dissociative Experiences Scale (DES) Total Score [ Time Frame: Baseline (Day 0), follow-up visit (Day 42) ]
  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

• 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: An EEG Study of Intravenous Ketamine for Major Depression Disorder
• Official Title: An Open Label Study of Electroencephalographic Responses Pre, During and Post, a Low Dose, Weekly Intravenous Ketamine Infusion for 4 Weeks, in a Study Population With Major Depression Disorder
• Brief 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.

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.

• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Open-label, single-arm

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Major Depressive Disorder

Intervention

Drug: Ketamine Hydrochloride

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

Other Name: NDC 67457-108-00

Study Arms

Experimental: Ketamine

50-60 minutes intravenous infusion of 60mg ketamine

Intervention: Drug: Ketamine Hydrochloride

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 16, 2022): 35
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2024
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jeffrey D Kamlet, MD; 305 604 9595; jeffrey@tristarwell.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05506462
• Other Study ID Numbers: 21EERPZ01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ehave Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Ehave Inc.
• Original Study Sponsor: Same as current
• Collaborators: Tristar Wellness

Investigators

• Principal Investigator: Jeffrey D Kamlet, MD; Tristar Wellness

• PRS Account: Ehave Inc.
• Verification Date: August 2022