An EEG Study of Intravenous Ketamine for Major Depression Disorder

NCT05506462 | Unknown Phase 4 FDA Drug

• 1 other identifier: 21EERPZ01
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Keywords

Intravenous ketamine; Electroencephalogram (EEG) monitoring; Major depressive disorder

Outcome Measures

Primary Outcomes (8)

• 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

  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).

  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

  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).

  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

  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).

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Pre-treatment baseline, 4 weeks post-treatment course

Secondary Outcomes (5)

• Incidence of medically significant changes in blood pressure during ketamine infusion

  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

  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

  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

  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

  Baseline (Day 0), follow-up visit (Day 42)

Study Arms (1)

Ketamine

EXPERIMENTAL

50-60 minutes intravenous infusion of 60mg ketamine

Drug: Ketamine Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

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

Ketamine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals between 18 and 70 years of age, inclusive
• Adult patients with a documented primary Axis I clinical diagnosis meeting criteria from the DSM-V for a major depressive disorder
• Score of \<15 on the DES
• Moderate to severe symptoms objectively documented using MADRS total score of ≥ 20
• Ability to maintain scheduled appointments for screenings, 4 treatment visits and follow-up EEG visit.
• History of major depressive disorder.
• 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.
• Must have stable residence address, internet and mobile phone.
• Must speak fluent English.

You may not qualify if:

• Known allergy to ketamine or any other drug used in the study.
• Use of ketamine in a therapeutic model within the preceding 12 months of the study.
• Current or any history of schizoaffective disorder(s).
• Score of ≥ 15 on DES
• 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.
• Pregnancy, breastfeeding or desire to become pregnant during the course of the study.
• 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.
• Any history of cerebral vascular events including stroke, bleeding into the brain and subdural hematomas.
• Any implantable metallic device(s) or implant(s) above the level of shoulders.
• Any non-removable metallic piercings.
• Patients with cochlear implants and non-removable hearing aids.
• Current use of: Dilantin, Depakote, Phenobarbital, Gabapentin, Pregabalin and Benzodiazepines. Certain candidates with long use of Benzodiazepines may qualify at PI's discretion.
• Severe labile hypertension.
• Significant uncontrolled hypertension (i.e., SBP \> 150 mmHG, DBP \> 100 mmHG)
• Uncontrolled diabetes mellitus.

Sponsors & Collaborators

• Ehave Inc.: lead
• Tristar Wellness: collaborator

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jeffrey D Kamlet, MD

  Tristar Wellness

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey D Kamlet, MD

CONTACT

305 604 9595; jeffrey@tristarwell.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, single-arm

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 18, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share