Major Depressive DisorderPhase 4NCT05506462
An EEG Study of Intravenous Ketamine for Major Depression Disorder
A Phase 4 study testing Ketamine Hydrochloride in people with Major Depressive Disorder, run by Ehave Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Ketamine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Ketamine Hydrochloride
- Keywords
- Intravenous ketamine, Electroencephalogram (EEG) monitoring, Major depressive disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Also called NDC 67457-108-00
Patients with a diagnosis of Major Depressive Disorder (MDD) will be enrolled to receive four 50-60 minute infusions of 60mg ketamine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | 50-60 minutes intravenous infusion of 60mg ketamine Receives: Drug: Ketamine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-treatment baseline, 4 weeks post-treatment course
Secondary outcomes (5)
Incidence of medically significant changes in blood pressure during ketamine infusion
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: Baseline (Day 0), follow-up visit (Day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single-arm
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ehave Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tristar Wellness
- Responsible party
- Sponsor
- Investigators
- Jeffrey D Kamlet, MD, Principal investigator, Tristar Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506462
- Sponsor's protocol ID
- 21EERPZ01
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05506462
- Acronym / sponsor ID
- 21EERPZ01
- Conditions
- Major Depressive Disorder
- Keywords
- Intravenous ketamine, Electroencephalogram (EEG) monitoring, Major depressive disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Ehave Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tristar Wellness
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single-arm
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: Ketamine Hydrochloride50-60 minutes intravenous infusion of 60mg ketamine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine HydrochlorideAlso: NDC 67457-108-00Patients with a diagnosis of Major Depressive Disorder (MDD) will be enrolled to receive four 50-60 minute infusions of 60mg ketamine hydrochloride | Drug | Ketamine |
Primary outcome
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
5 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey D Kamlet, MD principal investigator
Tristar Wellness
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine Hydrochloride in people with Major Depressive Disorder, run by Ehave Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey D Kamlet, MD (305 604 9595, jeffrey@tristarwell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.