Back to resultsAn EEG Study of Intravenous Ketamine for Major Depression Disorder
Primary Purpose
Major Depressive Disorder
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Intravenous ketamine, Electroencephalogram (EEG) monitoring, Major depressive disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Patients on renal dialysis.
- Inability to achieve consistent IV access.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ketamine
Arm Description
50-60 minutes intravenous infusion of 60mg ketamine
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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
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
Secondary Outcome Measures
Incidence of medically significant changes in blood pressure during ketamine infusion
Incidence of medically significant changes in Oxygen Saturation (SpO2) during ketamine infusion
Incidence of medically significant changes in heart rate during ketamine infusion
Incidence of medically significant changes in respiratory rate during ketamine infusion
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
Full Information
NCT ID
NCT05506462
First Posted
August 9, 2022
Last Updated
August 18, 2022
Sponsor
Ehave Inc.
Collaborators
Tristar Wellness
1. Study Identification
Unique Protocol Identification Number
NCT05506462
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ehave Inc.
Collaborators
Tristar Wellness
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Intravenous ketamine, Electroencephalogram (EEG) monitoring, Major depressive disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open-label, single-arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
50-60 minutes intravenous infusion of 60mg ketamine
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Other Intervention Name(s)
NDC 67457-108-00
Intervention Description
Patients with a diagnosis of Major Depressive Disorder (MDD) will be enrolled to receive four 50-60 minute infusions of 60mg ketamine hydrochloride
Primary Outcome Measure Information:
Title
Characterizing the changes in EEG reading frequencies from pre- IV ketamine infusion treatment (baseline).
Description
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)
Title
Characterizing the changes in EEG reading waveforms from pre- IV ketamine infusion treatment (baseline).
Description
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)
Title
Characterizing the changes in EEG reading amplitudes from pre- IV ketamine infusion treatment (baseline).
Description
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)
Title
Characterizing the changes in EEG reading patterns from pre- IV ketamine infusion treatment (baseline).
Description
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)
Title
Characterizing the changes in EEG reading frequencies from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course
Description
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
Title
Characterizing the changes in EEG reading waveforms from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course
Description
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
Title
Characterizing the changes in EEG reading amplitudes from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course
Description
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
Title
Characterizing the changes in EEG reading patterns from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course
Description
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Changes from baseline in the Dissociative Experiences Scale (DES) Total Score
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Patients on renal dialysis.
Inability to achieve consistent IV access.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey D Kamlet, MD
Phone
305 604 9595
Email
jeffrey@tristarwell.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey D Kamlet, MD
Organizational Affiliation
Tristar Wellness
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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An EEG Study of Intravenous Ketamine for Major Depression Disorder
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