Treatment-resistant DepressionNCT05095792
Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)
An observational study of Treatment-resistant Depression, run by Entheon Biomedical Corp. at 1 site in United States.
Trial summary
This observational study will allow data to be collected to demonstrate changes in brain activity following administration of standard of care (SOC) Ketamine. By comparing genetic markers across participants, data on impact of genetic markers and response to Ketamine will also be analysed. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Treatment-resistant Depression
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 21 Oct 2022
- Phase
- Observational
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Male or female participants with treatment-resistant Major Depressive Disorder aged 21-60 interested in receiving intra-muscular injections of ketamine over 10 sessions in the clinic and willing to wear an electroencephalogram (EEG) headset to measure their brain wave patterns.
Who may be able to join
- Primary Diagnostic and Statistical Manuel of Mental Disorders 5 (DSM-V) diagnosis of treatment-resistant Major Depressive Disorder (may have secondary diagnoses of general anxiety, substance disorder)
- Non-responders to at least 2 previous anti-depressant medications prescribed by a physician in the past five years
- Score of ≥20 on Montgomery-Asberg Depression Rating Scale (MADRS) (i.e., moderate to severe depression)
- All genders aged 21 to 60 years of age
- Prescribed Ketamine or currently being treated with Ketamine for treatment-resistant Major Depressive Disorder
- Willing to wear an Electroencephalogram (EEG) headset and an eye mask
- Willing to listen to ambient sound
- Willing to have a genetic cheek swab
Who cannot join
- Pregnancy
- Traumatic Brain Injury within past 3 months
- Body weight < 50 kg or > 120 kg
- Coronary heart disease
- Uncontrolled hypertension as defined in the American College of Cardiology/American Heart Association (ACC/AHA) Hypertension Guidelines
- Previous contact with Ketamine (therapeutically or recreationally) outside of treatment at the study site
Show all 17Show fewer
- Primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
- Bipolar disorder with current manic, hypomanic or mixed state
- Post-traumatic stress disorder
- Obsessive-compulsive disorder
- Primary substance-use disorder
- Alcohol consumption 24 hours prior and 48 hours subsequent to treatment
- Currently using any of the following medications:
- Benzodiazepines for 6 hours prior to treatment and 2 hours after treatment
- Lamotrigine for 6 hours prior to treatment
- Amphetamine-based stimulants for 6 hours prior to treatment
- Monoamine Oxidase Inhibitors (MAO-Is) may be taken but blood pressure must be monitored
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Ketamine on Neurological Activity as Measured by Quantitative EEG
This observational study will allow data to be collected to demonstrate changes in brain activity following administration of standard of care (SOC) Ketamine. By comparing genetic markers across participants, data on impact of genetic markers and response to Ketamine will also be analysed. This data will contribute to the design of future studies utilizing Ketamine for various psychiatric disorders. This study will focus on treatment-resistant Major Depressive Disorder (MDD).
Read the detailed description
This is an Open Label Observational Study with the primary objective to assess brain activity in patients prior to, during and after Ketamine treatment and to assess genetic markers prior to Ketamine treatment. This is a non-interventional study that will observe the Electroencephalogram (EEG) pattern of participants who, per standard of care, are treated with intramuscular Ketamine. The administration of the Ketamine during this study is not considered investigational. The experimental intervention, measurements via EEG, will be offered to patients of the study site presenting for intramuscular (IM) ketamine treatment per the site's established and evidence-based protocol as part of their regular clinical care. Participants in this study have already been determined to have a medically appropriate indication for IM Ketamine treatment, independent of enrollment in this study. Given the requirement, per study protocol, to wear an EEG headset and complete study measures, participants will be compensated by having treatment costs paid by the study sponsor. There will be 36 participants enrolled at one study site.
- Conditions
- Treatment-resistant Depression
- Being tested
- Observational - no intervention
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational - no interventionOther
This is an observational study with no intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter and intra patient variability in neurological activity.
Observation of the the inter and intra patient variability in neurological activity.
Measured: Up to 74 days
Secondary outcomes (4)
Genetic markers on neurological phenotypes
Correlation of neurological phenotypes with genetic markers
Measured: Baseline
CADSS-6 correlation with neurological phenotypes
Correlation of neurological phenotypes of Clinician Administered Dissociative Symptom Scale (CADSS-6).
Measured: Up to 67 days
QIDS SR-16 correlation with neurological phenotypes
Correlation of neurological phenotypes of depressed patients with Quick Inventory of Depressive Symptomatology (QIDS SR-16)
Measured: Up to 67 days
PMQ-SF correlation with neurological phenotypes
Correlation of neurological phenotypes Psychedelic Music Questionnaire Short Form (PMQ-SF)
Measured: Up to 67 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start9 Nov 2021
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Why it stopped: Business decision to stop enrollment after 1 participant completed the study. Will not be reopening.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-resistant DepressionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entheon Biomedical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Levine, MD, Principal investigator, Heading Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095792
- Sponsor's protocol ID
- EBIQ-101
- Status last verified
- Nov 2024
- First submitted
- 5 Oct 2021
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Ketamine on Neurological Activity as Measured by Quantitative EEG
- ClinicalTrials.gov ID
- NCT05095792
- Acronym / sponsor ID
- EBIQ-101
- Conditions
- Treatment-resistant Depression
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision to stop enrollment after 1 participant completed the study. Will not be reopening.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Entheon Biomedical Corp.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 27 Oct 2021 (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.
This observational study will allow data to be collected to demonstrate changes in brain activity following administration of standard of care (SOC) Ketamine. By comparing genetic markers across participants, data on impact of genetic markers and response to Ketamine will also be analysed. This data will contribute to the design of future studies utilizing Ketamine for various psychiatric disorders. This study will focus on treatment-resistant Major Depressive Disorder (MDD).
Detailed description
This is an Open Label Observational Study with the primary objective to assess brain activity in patients prior to, during and after Ketamine treatment and to assess genetic markers prior to Ketamine treatment. This is a non-interventional study that will observe the Electroencephalogram (EEG) pattern of participants who, per standard of care, are treated with intramuscular Ketamine. The administration of the Ketamine during this study is not considered investigational. The experimental intervention, measurements via EEG, will be offered to patients of the study site presenting for intramuscular (IM) ketamine treatment per the site's established and evidence-based protocol as part of their regular clinical care. Participants in this study have already been determined to have a medically appropriate indication for IM Ketamine treatment, independent of enrollment in this study. Given the requirement, per study protocol, to wear an EEG headset and complete study measures, participants will be compensated by having treatment costs paid by the study sponsor. There will be 36 participants enrolled at one study site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male or female participants with treatment-resistant Major Depressive Disorder aged 21-60 interested in receiving intra-muscular injections of ketamine over 10 sessions in the clinic and willing to wear an electroencephalogram (EEG) headset to measure their brain wave patterns.
Key inclusion criteria (8 listed)
- Primary Diagnostic and Statistical Manuel of Mental Disorders 5 (DSM-V) diagnosis of treatment-resistant Major Depressive Disorder (may have secondary diagnoses of general anxiety, substance disorder)
- All genders aged 21 to 60 years of age
- Prescribed Ketamine or currently being treated with Ketamine for treatment-resistant Major Depressive Disorder
- Willing to wear an Electroencephalogram (EEG) headset and an eye mask
- Willing to listen to ambient sound
Key exclusion criteria (17 listed)
- Pregnancy
- Traumatic Brain Injury within past 3 months
- Body weight < 50 kg or > 120 kg
- Coronary heart disease
- Uncontrolled hypertension as defined in the American College of Cardiology/American Heart Association (ACC/AHA) Hypertension Guidelines
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 |
|---|---|---|
| Observational - no interventionThis is an observational study with no intervention. | Other | – |
Primary outcome
Inter and intra patient variability in neurological activity.
Time frame: Up to 74 days
Observation of the the inter and intra patient variability in neurological activity.
4 secondary outcomes
Genetic markers on neurological phenotypes
Time frame: Baseline
CADSS-6 correlation with neurological phenotypes
Time frame: Up to 67 days
QIDS SR-16 correlation with neurological phenotypes
Time frame: Up to 67 days
PMQ-SF correlation with neurological phenotypes
Time frame: Up to 67 days
Results and safety
The study was stopped early (reason given: Business decision to stop enrollment after 1 participant completed the study. Will not be reopening.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Treatment-resistant Depression
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression
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.
Steven Levine, MD principal investigator
Heading Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment-resistant Depression, run by Entheon Biomedical Corp. at 1 site in United States.
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 8 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: stopped early, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: Business decision to stop enrollment after 1 participant completed the study. Will not be reopening.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter and intra patient variability in neurological activity. (time frame: Up to 74 days). 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 14 Nov 2024.